A highlight was welcoming a new observer member – Singapore’s Health Sciences Authority (HSA) – as well as new affiliate members: Mexico’s Cofepris, and Kenya’s Kenya Pharmaceutical Poison Board (KPPB). The RAC chair from Australia outlined MDSAP’s strategic priorities, focusing on sustainability, transparency, and efficiency, and discussed potential program expansion.

Use of MDSAP by ANVISA

ANVISA has increasingly relied on MDSAP reports to issue Good Manufacturing Practice (GMP) Certificates. The table below highlights the number of GMP certificates issued based on MDSAP reports over the years:

Furthermore, as emphasized in ANVISA’s presentation at the ABIMED Regulatory Journey held in May this year, ANVISA aims to achieve the goal of having 80% of issued certificates utilizing the MDSAP program. Fifteen Auditing Organizations evaluated and approved through the MDSAP program have already received ANVISA recognition. According to information provided by ANVISA at the event, approximately seven thousand companies are already participating in the MDSAP program globally.

Regulatory Development: RDC 850/2024

In March 2024, ANVISA announced a significant regulatory development with the publication of Resolution RDC 850/2024. This regulation extends the validity period of the Brazilian Good Manufacturing Practices (BGMP) Certificate from two to four years for manufacturers participating in the MDSAP.

GMP Certification Database

ANVISA offers a comprehensive GMP Certification Database designed to support effective management and oversight. This database allows users to perform searches based on relevant criteria, view geographic distributions of certifications, and filter by certification status. Updated on a weekly basis, it ensures that stakeholders have access to the most current information. The database is a valuable resource for companies and regulatory bodies to monitor compliance and maintain high standards in manufacturing practices. For more details and to access the database, visit here.

The next in-person RAC meeting is scheduled to be held alongside the International Medical Device Regulators Forum (IMDRF) in Seattle, USA, in September 2024.

For updates on key developments in the Brazilian regulatory system, follow us on social media.

DOMO Salute Team

O post MDSAP Forum: Highlights Include Strategic Discussions, New Member Inductions, and Regulatory Developments apareceu primeiro em Domo Salute.

In force since January 2022, RDC 591/2021, which provides for the Unique Device Identification (UDI) system, was amended by ANVISA just days before the deadline for attributing and affixing UDI to risk class IV devices. The amendment was published in RDC 884/2024 on June 1, 2024, and is already in force.

According to ANVISA, as the deadlines for adapting to the obligations stipulated by RDC 591/2021 approach, specific adjustments have been identified in the Resolution that could enhance their regulatory impact.

The new deadlines set by ANVISA for attributing and affixing UDI to medical devices, based on their risk classification and calculated from the effective date of RDC 591/2021, are as follows:

In summary, medical devices in classes II, III and IV have been granted an additional year to comply, while risk class I products retain the same previously established deadline.

ANVISA utilized RDC 884/2024 to implement specific adjustments to RDC 591/2021, including:

The essential data elements to be provided to the UDI database, as well as information about the UDI system, are detailed in the annexes of RDC 591/2021, which have been updated by RDC 884/2024.

The regulated sector is eagerly awaiting ANVISA’s publication of a normative instruction regarding the transmission of information to the UDI database to transmit the UDI in notifications of adverse events, technical complaints, and field actions. This normative instruction should explicitly state that ANVISA’s UDI database is fully equipped to receive and incorporate UDI information, and it should outline the procedures for data submission.

These adjustments offer manufacturers and stakeholders more time to ensure compliance with UDI requirements, thereby facilitating smoother integration and alignment with regulatory standards. This extension acknowledges the complexities involved in adopting UDI systems and aims to enhance the effectiveness and readiness of the healthcare sector in Brazil.

For updates on key developments in the Brazilian regulatory system, follow us on social media.

DOMO Salute Team
by Ângela Soska

Updated on July 4th to reflect ANVISA’s correction of the Resolution number from RDC 886/2024 to RDC 884/2024.

O post ANVISA’s Latest Guidelines and Regulatory Updates for UDI Compliance apareceu primeiro em Domo Salute.

According to the IN, effective on June 3, 2024, medical devices classified as risk III and IV, and previously authorized by at least one of the four Recognized Equivalent Foreign Regulatory Authorities (EFRAs) – Australia, Canada, the USA, and Japan – are eligible to undergo optimized dossier analyses upon request from interested companies.

To qualify for review by regulatory reliance, the medical device intended for the Brazilian market must mirror the one already approved by the recognized foreign regulatory authority. Evidence of the registration or authorization issued by the EFRA must be provided, demonstrating that the device to be regulated in Brazil shares identical production characteristics, indications, and uses as approved by the equivalent regulatory authority.

The request for streamlined analysis, including the documents specified by IN 290/2024, must be submitted as a secondary petition along with the registration request. It should be noted that the registration request must still contain documents required by other pertinent Brazilian regulatory standards for medical devices and IVDs, which remain necessary.

ANVISA’s retains decision-making autonomy, allowing independent decisions regardless of EFRA approvals, and may request a standard registration process if necessary.

At DOMO, our priority is keeping our clients accurately and timely informed. Stay updated on the latest developments in the Brazilian regulatory landscape by following us on social media to. For more information, do not hesitate in contacting our Regulatory Affairs team.

O post ANVISA implements regulatory reliance mechanisms to streamline the evaluation process of medical devices already approved by Equivalent Foreign Regulatory Authorities (EFRAs) apareceu primeiro em Domo Salute.

Today, ANVISA has announced a significant regulatory development with the publication of Resolution RDC 850/2024. This regulation brings forth a crucial amendment concerning the validity period of the Brazilian Good Manufacturing Practices (BGMP) Certificate for manufacturers operating under the Medical Device Single Audit Program (MDSAP) framework. It approves the extension of BGMP certificate validity from two to four years, exclusively for manufacturers participating in the MDSAP.

Key Points from RDC 850/2024:

• The Resolution becomes effective on April 1^st, 2024;
• The extension of the BGMP certificate’s validity period allows to reduce the financial burden on companies, by elongating the interval between payments of associated certification fees in Brazil.

Important Notes to Consider:

• The 4-year validity period is contingent upon the manufacturer’s continued participation in the MDSAP program during the BGMP Certification period;
• For petitions submitted before the Resolution’s effective date but not yet published, the extended validity period will apply.
• BGMP Certificates already issued will retain their original 2-year validity. Only new certificates and renewals will benefit from the extended validity.

MDSAP certification stands as a valuable strategy for manufacturers, given that the certification process with ANVISA is expedited and now boasts an extended validity compared to BGMP certificates obtained outside the program.

At DOMO, we are dedicated to staying at the forefront of regulatory developments, ensuring our clients benefit from timely and accurate information. Stay connected with us on social media for the latest updates on key developments in the Brazilian regulatory landscape.

For further inquiries or assistance in navigating these regulatory updates, do not hesitate to reach out to our Regulatory Affairs team.

O post Navigating Regulatory Changes: ANVISA Extends BGMP Validity for Manufacturers under MDSAP apareceu primeiro em Domo Salute.

One of the significant changes brought about by the new RDC is the consolidation of information to be submitted to ANVISA, eliminating the need for the submission of two separate dossiers for the study approval process. Now, all documentation related to the medical device and the clinical investigation plan will be submitted under a single dossier process known as the Clinical Investigation Dossier for Medical Devices (DICD), streamlining the analysis.

In terms of ANVISA’s approval scope, starting from the effective date, only clinical investigations with results that may support the registration of Risk Class III and IV medical devices in Brazil will be eligible for submission to the Agency. Consequently, the regulation eliminates the need to submit post-commercialization studies and those related to Risk Class I and II medical devices for ANVISA’s prior approval. 

The regulatory update also adopts a more convergent terminology, harmonizing with RDC 751/2022 regarding the development of medical devices. Additionally, it eliminates the requirement for the detailed opinion of the Research Ethics Committee (CEP) from the list of documents for the initial submission of clinical research with medical devices.

Concerning the importation of medical devices exclusively for clinical trials in Brazil, the regulation specifies that importations are subject to analysis and approval by the health authority through the SISCOMEX (Integrated Foreign Trade System) platform, which makes import-related processes more efficient and standardized.

Our team continues to monitor Brazilian regulatory trends, ensuring our clients benefit from accurate and timely information.

Stay connected with us on social media for the latest updates on key developments in the Brazilian regulatory landscape.

*Article based on ANVISA’s publication, available here.

O post Insights into the Practical Implications for Medical Device Clinical Investigation requirements in Brazil apareceu primeiro em Domo Salute.

The new RDC, effective from June 1, 2024, is a comprehensive revision that consolidates risk classifications and regularization procedures across all IVD risk classes, rendering the previous RDC 36/2015 obsolete. Furthermore, it encompasses procedures for modifications, the mandatory provision of instructions for use in ANVISA’s documentary repository and non-printed formats, leading to the revocation of RDCs 340/2020 and 431/2020, as well as IN 4/2012.

In light of the integration of previously scattered themes in various regulations, the implementation of RDC 830/2023 streamlines the oversight of regulatory processes necessary for upholding the regularization of in vitro diagnostic (IVD) devices with ANVISA.

The risk classification and registration procedures for other medical devices (materials and equipment) remain in line with the directives of RDC 751/2022. Both RDC 830/2023 and RDC 751/2022 share analogous structures and requirements, delineating technical specifics based on each product’s scope.

Key changes in the new resolution include:

• Comprehensive Regulations: RDC 830/2023 consolidates Notification, Registro, changes, and revalidation regulations for IVDs, streamlining compliance requirements;
• The numbering of classification rules closely aligns with EU MDR standards, fostering global regulatory coherence, including:
  • Specific risk classification rules for IVD instruments that do not use reagents; products for detecting transmissible agents, or for evaluating immunological compatibility in cell administration procedures;
  • Classification rules for companion diagnostics and products for neonatal screening;
  • Controls without assigned values are now considered in vitro diagnostic medical devices and must be registered before ANVISA within 1 year after the normative becomes effective;
  • Furthermore, there will no longer be differentiation regarding risk-classification for products aimed at blood gases or glucose, whether or not they are Point of Care Testing (PoCT).
• New definitions, concepts, and modernized text with updated terminology;
• Incorporation of Essential Regulations: The resolution incorporates crucial regulations, including:
  • Modification on registered IVDs: Describes the types of alterations and requirements for petition and implementation. Previously described in RDC 340/2020 (to be revoked);
  • Document Repository: ANVISA’s Documentary Repository for Medical Devices mandates the provision of product instructions for use on the ANVISA website, enhancing accessibility and transparency. Previously outlined in RDC 431/2020 (to be revoked);
  • Non-Printed Format Guidelines: Regulations regarding non-printed format instructions for use and their prerequisites are incorporated, aligning with contemporary documentation practices, applicable for calibrators and controls. Previously described in IN 4/2012 (to be revoked);
• Adoption of the Table of Contents structure (IVD MA ToC) from IMDRF for Technical Dossiers, signaling a commitment to regulatory convergence and international alignment;
• Provision for stock depletion of products, packaging, labels, and instructions for use in the event of changes to in vitro diagnostic medical devices;
• Formalization of the procedural reassessment for in vitro diagnostic devices, a process a process wherein previously approved Notifications and Registros may undergo scrutiny by ANVISA’s technical area;
• For cases of medical devices transitioning from a Notification to a Registro process due to the updated classification rules, the regulation establishes a one-year period from its effective date for the submission of sanitary reclassification petitions.

Our team continues to monitor Brazilian regulatory trends, ensuring our clients benefit from accurate and timely information.

Stay connected with us on social media for the latest updates on key developments in the Brazilian regulatory landscape.

By Ângela Soska

O post Navigating the Impacts of RDC 830/2023 apareceu primeiro em Domo Salute.

In the dynamic landscape of medical device regulations in Brazil, obtaining the Brazilian Good Manufacturing Practices (BGMP) certification is a mandatory request for manufacturers of Class III and Class IV devices seeking Registro.

In a recent move towards regulatory efficiency, ANVISA introduced a Public Consultation (Consulta Pública n° 1.208, October 16, 2023) proposing the extension of BGMP certificates validity from two to four years for manufacturers participating on the MDSAP program.

The consultation period invites stakeholders to contribute their perspectives on this potential regulatory amendment. If approved, the change would signify a strategic shift, amplifying the benefits of an MDSAP certified manufacturer, contingent upon the maintenance of participation in the MDSAP program during the term of the BGMP certificate.

The Medical Device Single Audit Program (MDSAP) represents a stride towards regulatory convergence, fostering greater global alignment based on international best practice standards and streamlining health regulation. The program’s efficiency is evident in the prompt application of Good Manufacturing Practices, frequently achieved exclusively through document analysis, possibly eliminating the necessity for a new audit by ANVISA. The manufacturer’s MDSAP certification provides a streamlined pathway for the granting and renewal of the BGMP certificate, thereby expediting the process of product registration and commercialization in Brazil.

The new proposal may allow for a reduction in the financial burden on companies, as the extension of the certificate’s validity will result in a longer interval between payments of fees associated with the certification process.

At DOMO, we are committed to staying at the forefront of regulatory developments, ensuring our clients benefit from timely and accurate information. Stay connected with us on social media for the latest updates on key developments in the Brazilian regulatory landscape.

By Thatiana Terroso & Ângela Soska

O post Proposed Extension of BGMP Certificate’s Validity: Navigating Regulatory Efficiency with MDSAP apareceu primeiro em Domo Salute.

Starting today – March 1st 2023 – the new Resolution RDC nº 751/2022  comes into force. The Resolution provides for risk classification, Notification and Registro processes, and the requirements for medical devices’ labeling and instructions for use.

In order to meet the new requirements and procedures, ANVISA has already made available new forms for Notification and Registro, as well as updated the list of necessary documents for the regularization of medical devices in Brazil.

Click here to read the full article containing more information on major updates and highlights prepared by our team.

O post New Resolution regarding medical devices’ risk classification and regularization comes into force apareceu primeiro em Domo Salute.

The new RDC consolidates the risk classification and regularization regimes for all risk classes, unifying RDC 185/2001 (classification rules and procedures for Registro – class III and IV medical devices) and RDC 40/2015 (procedures for Notification and technical dossier – risk class I and II medical devices), which will be revoked. The new resolution also includes the requirements for BGMP’s proof of compliance, currently described in RDC 15/2014 – which will also be revoked.

The procedures for risk classification and regularization of in vitro diagnostic devices (IVDs) are not covered by this resolution and will still follow the guidelines established in RDC 36/2015.

We highlight the main changes of the new resolution:

• Inclusion of new risk classification rules: specific classification rules will be adopted for new technologies, such as Software as Medical Device (SaMD) and nanomaterials. The new classification rules are closely aligned with the EU MDR rules.
• Consolidation of the rules for Notification, Registro, alterations and renewals;
• Adoption of new definitions and concepts, such as updating the definition of a medical device, including the definition of a registration holder, among others;
• Incorporation of the regulation for Medical Devices’ Documentary Repository (mandatory upload of Instructions for Use on ANVISA’s portal), already in force according to RDC 431/2020;
• Incorporation of rules for Instructions for Use in electronic format and their requirements;
• Adoption of the Table of Contents structure (IMDRF’s Table of Contents) for Technical Dossiers, enabling the use of dossiers prepared for multiple jurisdictions (regulatory convergence);
• Possibility of stock depletion of the products, including their packaging, labels and instructions for use in case of alteration of medical devices;
• Formalization of the procedural reassessment process, in which approved Notifications and Registro can be audited by ANVISA’s technical team;
• Text modernization and terminology update.

RDC 751/2022 comes into force on March 1^st, 2023.

In case a medical device registered through the Notification route falls into a higher Risk Class according to the new rules, and needs to be reclassified as a Registro, the new resolution establishes a timeframe of one year from the beginning of its validity for a reclassification petition to be filed.

With the new text, RDC 751/2022 consolidates a series of previous regulations issued by ANVISA, strengthening itself as the main rule regarding the regularization of medical devices in Brazil. The revision of terms and concepts and the modernization of the wording are also factors that lead to communication gain with the regulated sector. Finally, the new Resolution becomes a more internationally aligned normative, either with Mercosur, through the internalization of Mercosur Resolution GMC nº 25/2021, which updated the documentary requirements and classification rules for medical devices applicable to the region, or with European regulation, through the establishment of rules for risk classification similar to the EU MDR.

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DOMO Salute Team

O post ANVISA updates the main resolution which guides medical devices’ risk classification and regularization in Brazil apareceu primeiro em Domo Salute.

RDC 687/2022 applies to risk class III and IV medical devices’ manufacturing units producing final products on their behalf or for other companies (including Software as a Medical Device – SaMD), or that carry out final releases of final products and that are involved in at least on stage of production other than design, distribution, sterilization, packaging or labeling stages.

Check the main changes when comparing to the previous resolution:

• Extends the scope of the resolution to all national and international establishments, no longer being restricted to establishments located outside of the national territory and Mercosur.

• Includes the mandatory certification for manufacturing units with packaging activities considered as a sterile barrier system for products declared as sterile, as well as manufacturing units of medical devices for in vitro diagnostics that perform the steps of impregnation, immunochromatography lamination or strip cutting.

• Updates the list of documents required for BGMP petition of granting and renewal processes.

• Accepts inspection reports issued by auditing bodies within the scope of a specific audit program recognized by ANVISA which were issued up to 3 years before the protocol date.

• Establishes that, in case of non-conformities listed in the audit report, an action plan must be forwarded to ANVISA and – if the non-conformity is still open – a request to comply with additional requirements will be issued.

• Certificates issued based on documentation analysis will not exempt the company from receiving on-site inspection by ANVISA, at any time. Refusal to receive the inspection or requests to change dates not accepted by ANVISA results in cancellation of the BGMP Certificate.

• Establishes a maximum period of 180 (one hundred and eighty) days for new manufacturing units within the scope of the new Resolution to apply a request for BGMP Certification.

Manufacturers must submit the following documents to request a BGMP Certificate:

To renew the BGMP Certificate, it is necessary to present the application Form as well as inspection and audit reports carried out. The other documents are necessary only in case it is necessary to update the information previously presented.

The resolution RDC 687/2022 also mentions the publication of the Risk Matrix used for risk analysis which subsidizes the granting of the BGMP Certificate through documentary evaluation, allowing greater understanding of the evaluation criteria. The Matrix disclosed considers the result of documents’ evaluation, the complexity of the manufacturing unit, the technologies involved and the intrinsic risk of the devices and indication of use, amongst others.

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DOMO Salute Team

O post ANVISA updates the resolution for Brazilian Good Manufacturing Practices Certification granting and renewal apareceu primeiro em Domo Salute.

The Brazilian Good Manufacturing Practices (BGMP) requirements apply to manufacturers of medical devices and in vitro Diagnostic Products, as well as distributors, storers and importers of products that are marketed in Brazil. RDC No. 665/2022 establishes the requirements that describe the Good Manufacturing Practices for methods, controls and other processes related to the design, purchase, and manufacture of devices and IVDs. The updated BGMP requirements also address the packaging, labeling, storage, distribution, installation and service processes applicable to medical devices and IVDs.

In the process of updating the standard which deals with Good Manufacturing Practices, RDC No. 665/2022 revokes RDC No. 16/2013 and incorporates and revokes IN No. 8/2013. The update of the normative act does not, however, represent changes in merit compared to the norms that were revoked. Nevertheless, authorization letters and QMS documents must be updated with reference to current regulations.

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DOMO Salute Team

O post Brazilian Health Regulatory Agency updates Good Manufacturing Practices for medical devices and IVDs apareceu primeiro em Domo Salute.

According to the Agency, traditional regulations for medical devices present a gap, as they do not cover specific aspects for this type of products. Among ANVISA’s goals were the development of a regulatory model on the virtual and disruptive context of medical softwares, international alignment and cybersecurity regulation in connected devices.

The Resolution published by ANVISA defines SaMD as “software that meets the definition of a medical device, whether in vitro diagnostic (IVD) or not, being intended for one or more medical indications, and which performs these purposes without being part of a medical device”. Also included in the definition are mobile applications and software with in vitro purposes, if their indications are included in the general definition of medical devices, as well as software licensed by subscription and centrally hosted (Software as a Service), provided that it falls within the scope of medical devices’ definition.

The Resolution does not apply to:

* Software for well-being, intended to encourage and maintain well-being or control health and healthy lifestyle, without carrying out prevention, diagnosis, treatment, rehabilitation or contraception activities;

* Software listed as non-regulated products (in a list made available by ANVISA);

* Software used exclusively for administrative and financial management in health services;

* Software that processes demographic and epidemiological medical data, without any clinical diagnostic or therapeutic purposes;

* Software embedded in a medical device under sanitary surveillance.

For regularization purposes, SaMDs (including those for in vitro diagnostic use) must be classified according to the rules and classes presented in RDC 185/2001, or subsequent regulations.

In case of software’s distributed online, the label information and instructions for use can be made available in the software itself, in order to be exempt from physical presentations. In addition to the information required under current regulations for medical devices, instructions for use of SaMDs must include procedures for updating the SaMD; minimum hardware and software requirements; operating principle, including generic descriptions of algorithms, routines and formulas used to generate clinical processing; alerts and warnings; interoperability specifications, indication of software compatibilities and incompatibilities, hardware and technological environment; and cybersecurity information.

SaMDs’ regularization follows the general provisions for the regularization of medical devices. However, additional requirements related to the particularity of these devices must be included in the Technical Dossier – to be kept in the possession of the holding company, for class I and II SaMDs; or presented at the time of product registration, for Class III and IV SaMDs. Among these documents, the declaration of compliance with international standards or their national versions stands out, including:

I – IEC 62304:2006 – Medical device software — Software life cycle processes;

II – IEC 62366-1:2015 Medical devices — Part 1: Application of usability engineering to medical devices; e

III – ISO 14971:2007 Medical devices — Application of risk management to medical devices.

Other requirements can be checked in articles 11 and 12 of the Resolution.

SaMDs’ alterations must follow the general provisions contained in RDC 340/2020. Additionally, alterations that (I) create new functionalities or clinical indications of use; (II) significantly affect clinical functionality, clinical safety and efficacy, or performance associated with the foregoing purposes; and (III) mischaracterize the visual identity, so that the software is no longer recognizable in the images sent to ANVISA – must have an alteration petition filed with ANVISA.

The Resolution also addresses SaMD’s proof of safety and efficacy. It should be noted that the regularization processes granted prior to the effectiveness of this Resolution must be adequate or complemented when filing future alterations.

Despite the new Regulation, there were no changes regarding the rules for classifying SaMDs, which follow general rules for classifying medical devices according to RDC 185/2001. The legislation that will replace and update RDC 185/2001 is expected to be published this year, and will bring specific classification rules for SaMDs.

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DOMO Salute Team

O post ANVISA publishes Resolution for Software as a Medical Device – SaMD’s Regularization apareceu primeiro em Domo Salute.

Here are a few highlights on the requirements:

– COVID 19 test kits registrations that are already on the market cannot be turned into self-test registrations;

– ANVISA has defined minimum sensitivity and specificity values which the tests must meet. The tests will have to undergo prior analysis in a Brazilian laboratory (National Institute for Quality Control in Health);

– BRH must have a call center for user support, with direct access to qualified personnel to meet, guide and forward the interested party’s demands on the use of the product, interpretation of results and on how to proceed after obtaining the results;

– Additional requirements for Instructions for Use are: clear instructions for lay user to collect and perform the test, using photos or illustrations to facilitate the test and subsequent interpretation; hygiene conditions in order to proceed with the test, information related to covid-19’s prevention;

– BRH may make registry systems of test results available in the form of the National Testing Expansion Plan for Covid-19.

ANVISA will prioritize the analysis of COVID-19 self-test kits’ registration petitions, while the COVID-19 public health emergency persists in Brazil. COVID-19 self-test kits aim to bring additional aid to the Brazilian population to better detect and monitor infections, although in terms of guidance, it will not be considered conclusive as a diagnosis. It is worth mentioning that self-tests do not replace the diagnosis performed by a healthcare professional.

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DOMO Salute team

O post BRAZILIAN AGENCY ANVISA APPROVES USE OF COVID-19 SELF-TEST apareceu primeiro em Domo Salute.

The Unique Devices Identification is an international standard that complies with the International Medical Device Regulators Forum’s (IMDRF) guidance. It is defined as a series of numeric or alphanumeric characters created using a globally accepted device ID and encoding standard. These combined characters allow unambiguous identification of a particular medical device on the market.

With the beginning of the resolution’s validity, the deadlines stipulated by ANVISA for the UDI’s implementation to medical devices begins, according to their risk classification as follows:

For coronary artery stents, drug-eluting coronary artery stents and implants for hip and knee arthroplasty, the inclusion of the IDU support in traceability labels is mandatory as of the effective date of this Resolution.

The essential data elements to be provided to the UDI database, as well as information about the UDI system, are included in RDC 591/2021’s annexes.

Subsequently, ANVISA will publish normative instruction regarding the transmission of information to the UDI database and the transmission of the UDI in adverse events’ notifications, technical complaints and field actions. The normative instruction shall state that the Agency’s UDI database is able to receive and include UDI information, as well as the conditions to upload data.

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DOMO Salute Team

O post Regulation for Unique Device Identification (UDI) comes into force in Brazil apareceu primeiro em Domo Salute.

On the 18^th of November ANVISA informed that Resolution RDC 483/2021 was not extended. The Resolution, originally published in March this year, defined extraordinary and temporary requirements for the import of medical devices identified as priority by ANVISA due to the international public health emergency resulting from the new Coronavirus.

During the term of the Resolution, medical devices that fit the criteria were allowed to be imported on exceptional and temporary basis, and were exempted from sanitary regulation by ANVISA.

In addition, while the Resolution was in force, the strategic medical devices in fighting the pandemic listed in the Regulation could be imported with packaging, labels and package inserts according to the standards and language established by the foreign health authority responsible for approving their regularization.

This Resolution – which losts its effects on November 13th – also extended by one year the validity of medical device’s registrations granted in accordance with RDC nº 349/2020 (Temporary procedures for personal protective equipments, pulmonary ventilators and strategic medical devices). However, medical device’s registrations granted under the terms of RDC 349/2020 and which validity were extended by RDC 483/2021 will not be affected – they remain with 2 year valitidy since approval. After their expiration, a new registration under regular process will be requested before ANVISA in order to keep the medical device commercialization in Brazil.

According to ANVISA “It is worth noting that entities from the productive sector and technical areas of the Agency understand that the consumption-demand ratio of medicines and health products regulated in Brazil is once again balanced.” ANVISA also reitarates its commitment to remain alert and vigilant to adopt appropriate measures if necessary.

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DOMO Salute Team

O post medical devices’ import processes by RDC 483/2021 are extinct apareceu primeiro em Domo Salute.

Resolution RDC No. 431/2020, which came into force on November 1st 2020, granted a period of 1 year to make registered devices’ instructions for use available, for products which were approved by ANVISA before the rule came into force. For new registrations or product alterations approved after the Resolution, the deadline to upload instructions for use is up to 30 days after the approval.

Uploading the instructions for use is a responsibility of the Registration Holder, and the information must be aligned with the sanitary legislation and exactly according to the registration approved.

ANVISA provided a Guide for companies to upload the instructions for use.

The full text of Resolution RDC No. 431/2020 can be accessed here.

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O post Stay tuned! apareceu primeiro em Domo Salute.

The publications are part of the 4th stage of the review and consolidation process of the Agency’s normative acts, in compliance with Decree 10,139 / 2019 – known as the Revision Decree.

It is important to clarify that the new standards do not present technical changes in their content. The revision improves the legislative technique and the wording, updates normative terms and references and eliminates obsolete provisions, among other measures.

See the list of normative acts for the medical devices’ area:

*Resolution – RDC No. 539/2021: Establishes the minimum identity and quality requirements for Transfusion sets for single use with pressure infusion apparatus, gravitational infusion and infusion equipment for use with an infusion pump.
Revokes and replaces Resolutions – RDC No. 4/2011, RDC No. 9/2011, RDC No. 29/2014 and RDC No. 342/2020.

*Resolution – RDC No. 540/2021: Establishes the minimum identity and quality requirements for hypodermic needles and gingival needles.
Revokes and replaces Resolutions – RDC No. 5/2011, RDC No. 7/2012, RDC No. 28/2014 and RDC No. 344/2020

*Resolution – RDC No. 541/2021: Establishes the minimum identity and quality requirements for single-use sterile hypodermic syringes.
Revokes and replaces Resolutions – RDC No. 3/2011, RDC No. 8/2012, RDC No. 27/2014 and RDC No. 341/2020

*Resolution – RDC nº 542/2021: Defines “group of products” to which item 5.3 of Annex II of Law 9,782 of January 26^th, 1999 applies.
Revokes and replaces Resolution – RDC No. 97/2000

*Resolution – RDC nº 543/2021: Extends the application of notification of medical devices to textile yarns with thermal properties, indicated for the composition of garments with therapeutic, beautifying or aesthetic correction effects.
Revokes and replaces Resolution – RDC No. 6/2010

*Resolution – RDC No. 544/2021: Addresses plastic bags for the collection, storage and transfer of human blood and its components.
Revokes and replaces Resolution – RDC No. 35/2014

*Resolution – RDC No. 555/2021: Addresses the framing of the “Limulus Amebocyte Lysate (LAL) Reagent” in the medical devices’ Technical Regulation – Resolution – RDC No. 185, of October 22^nd, 2001.
Revokes and replaces Resolutions – RDC No. 301/2005 and RDC No. 104/2006

*Resolution – RDC No. 556/2021: Provides the grouping requirements for materials for health use for the purposes of Registro and Notification in the National Health Surveillance Agency, and adopts traceability labels for implantable devices.
Revokes and replaces Resolution – RDC No. 14/2011

*Normative Instruction – IN No.101/2021: Establishes specific criteria for grouping materials for health use into families for Registro and Notification purposes.
Revokes and replaces Normative Instructions – IN No. 6/2011 and IN No. 13/2016 

*Resolution – RDC No. 557/2021: Alters, revokes and replaces normative acts that are part of the fourth stage of the review and consolidation process of normative acts within the scope of ANVISA, in compliance with Ordinance No. 201/GADIP-DP/ANVISA, of 20th February 2020, and Decree No. 10.139, of November 28th, 2019.
Alters Normative Instruction – IN No. 21/2017
Amends Resolutions – RDC No. 67/2009, RDC No. 52/2015, RDC No. 145/2017, RDC No. 173/2017, RDC No. 375/2020 and RDC No. 448/2020
Revokes Normative Instructions – IN No. 3/2010, IN No. 7/2011 and IN No. 1/2013
Revokes Resolutions – RDC No. 3/2010, RDC No. 22/2013, RDC No. 348/2020, RDC No. 356/2020 and RDC No. 379/2020

*Resolution – RDC No. 560/2021: Addresses the organization of health surveillance actions, carried out by the Union, States, Federal District and Municipalities, related to the Operating Permit, Licensing, Registration, Good practices Certificate, Inspection and Standardization, within the scope of the National Health Surveillance System – SNVS.
Revokes and replaces Resolutions – RDC No. 207/2018, RDC No. 215/2018 and RDC No. 259/2018

DOMO Salute’s team will remain attentive to the Brazilian Regulatory Agencies movements and is available to clarify any doubts concerning the recent changes.

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O post ANVISA – 25 RDCs and 1 IN come into force apareceu primeiro em Domo Salute.

As well as defining more clearly the criteria for issuing all certificates (according to Annex C), the new RGCP also updated the version of the quality management system requirements to be verified in factory audit, and made it mandatory to carry out the certification’s closure process.

All RACs (Conformity Assessment Requirements) that previously did not mention the RGCP, shall be required to take this new regulation as basis for the following items:

• Certificate Issuance;
• Certification Request;
• Certificate of conformity;
• Activities Performed by OCP accredited by a IAF MLA member;
• Certification Transfer;
• Certification Closure;
• Conformity Identification Seal;
• Authorization to Use the Conformity Identification Seal;
• Responsibility and Obligations;
• Market Monitoring;
• Penalties;
• Complaints;
• ANNEX B – Certification Transfer – exclusively in cases of omission;
• ANNEX C – Additional Criteria for Certificate Issuance.

Therefore, within a maximum period of 6 months after their effectiveness, the new guidelines will impact all scopes of products that require compulsory certification in Brazil, thus unifying the general requirements for product certification processes.

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DOMO Salute Team

O post New General Product Certification Requirements – INMETRO apareceu primeiro em Domo Salute.

The Report shows that 161 regulatory instruments were published in 2020, covering Collegiate Board Resolutions (RDC), Normative Instructions (IN), Joint Normative Instructions (INC) and Guides. Regulations on drugs and medical devices were prevalent among those related to products subject to health regulation.

Due to the Covid-19 pandemic, there was an increase of 39.2% on regulations published by ANVISA. A total of 53 normative acts and 2 Guides were issued regarding the access to essential products and services in the fight against the new coronavirus.

ANVISA has also released a set of 106 proposals for Regulatory Projects that will compose the 2021-2023 Regulatory Agenda, which is expected to be published in April. There are 11 regulatory projects for the medical devices’ field:

• Implementation of the National Implant Registry (RNI) in Brazilian’s public and private health services
• Unique Device Identification (UDI) for medical devices
• Revision of the medical devices clinical trials’ normative (Resolution RDC No. 10/2015)
• Creation of a normative to increase the access to medical devices
• Updates on the Normative of Blood Bags Good Manufacturing Practices
• Reprocessing of Reusable Medical Devices
• Regulation of importation, commercialization and donation of used and refurbished medical devices
• Regulation for Software as a Medical Device
• Regularization of orthopedic implants
• Parametric release of medical devices
• Review of the Resolution RDC No. 183/2017, which provides the procedures to obtain the Brazilian Good Manufacturing Practices (BGMP) Certification for medical devices.

In addition, 140 Regulatory Process have been initiated, formalizing the start of the regulatory assessment that ends with the publication of normative by the Agency.

One of the stages of the regulatory processes is related to the Regulatory Impact Analysis (AIR). The first AIR concluded according to the new model in force is related to Economic monitoring and dissemination of medical devices’ information, wherewith ANVISA intends to face the regulatory problem of the “wide dysfunctionality of the Brazilian market for medical devices in Brazil, regarding imperfect and asymmetric information”. The subject was already assessed in Public Consultation and the new Regulatory Framework was published at Resolution RDC No. 478/2021, to enter into force on April 1^st 2021.

ANVISA also built a theoretical framework with the 1st Guideline for the implementation of the Monitoring and Evaluating Regulatory Results (M&ARR) within the scope of the Agency. The document aims to establish the bases to construct a governance and implementation model of procedures for M&ARR at ANVISA.

In order to simplify processes, ANVISA carried out the “Descarimba” Project and adapted 12 normative, exempting the authentication of copies and the signature recognition of certain documents presented to the Agency. With this measure, it is estimated that the sector will save R$ 693 thousand Brazilian reais per year.

Also in 2020, ANVISA decided about “frontier products”, which are products that weren’t clearly defined by the Agency within the regulatory framework. In this process, all artificial tears indicated exclusively for ocular lubrication had their sanitary framework defined as medical device.

In order to improve the regulatory quality of the Agency, ANVISA has 4 Strategic Goals and 5 Objectives defined in the Regulatory Quality Improvement Project. The Strategic Goals comprise the 2020-2023 ANVISA’s Strategic Plan, and includes expanding to 90% of the normative acts published as a result of its Regulatory Agenda, implementing 100% of the AIRs according to the new model in force, increasing to 24 medical devices with historical price monitoring and actions to reduce administrative costs. The Objectives of the regulatory improvement project includes the establishment of the AIR using culture, qualification of the access to the regulatory inventory, implementing the Monitoring and Evaluation of Regulatory Results and implementing the simplified model for measuring of the administrative burden.

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DOMO Salute Team

O post ANVISA: the advances of 2020 in regulatory quality improvement apareceu primeiro em Domo Salute.

Under the terms of the new Resolution, medical devices listed in Annex I of the Resolution may be imported on an exceptional and temporary basis by public and private bodies and entities, including health establishments and services, and are exempted from sanitary regulation by ANVISA.

Devices such as patient ventilator equipment, oximeter, patient monitor, infrared thermometer, among others listed on the World Health Organization’s (WHO) priority list, can be imported since they meet the criteria of the Resolution, such as presenting a proof of pre-qualification by WHO or a valid Registration in a country member of the International Medical Devices Regulators Forum – IMDRF. In addition, a proof of compliance with the Good Manufacturing Practices in the origin country, or equivalent, must be presented.

The importer must guarantee their origin, quality, safety and effectiveness, carry out post-market monitoring, guaranteeing the traceability, and comply with the applicable regulation.

In addition, while the Resolution is in force, the strategic medical devices in fighting the pandemic listed in the Regulation may be imported with packaging, labels and package inserts according to the standards and language established by the foreign health authority responsible for approving their regularization. It will be up to the importer to adopt risk mitigation actions considering the differences in information and formats between the original packaging, labels and package inserts in comparison with the national regulatory guidelines.

However, when important for the correct use of the product, the importer shall provide labels and instructions for use in Portuguese. The importer must also make public that the product has not been evaluated by Anvisa regarding the criteria of quality, efficacy and safety, and that the product is approved by a foreign health regulatory authority.

Moreover, the new Resolution extended by one year the validity of medical device’s registrations granted in accordance with RDC nº 349/2020 (Temporary procedures for personal protective equipments, pulmonary ventilators and strategic medical devices).

The alternative and temporary procedures described in the Resolution will be valid for 60 (sixty) days and may be renewed for equal and successive periods, and comes into force since the publication date.

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DOMO Salute Team

O post New temporary procedures to import medical devices announced to fight the new Coronavirus apareceu primeiro em Domo Salute.

The new regulation replaces Ordinance 54/2016 with new requirements for conformity assessment for equipment under health surveillance, establishing more clearly the competence of Certfication Bodies and ANVISA.

Amongst the main changes, we highlight:

– The certification body can now review the results of previous audit reports, performed according to MDSAP or ISO 13485, for example, and determine whether the test routine reports can be attested through document analysis, a desktop audit, or if an on-site audit will be required in order to comply with the test routine reports requirements.

– In case the device hasn’t been updated or altered after testing, there is no longer a requirement related to the issuance date of the report. Up to the publication of the new Ordinance, INMETRO certifiers could only accept 2 years old test reports for small and medium-sized equipment, and 4 years old test reports for large equipment.

– According to the new Ordinance, in some cases manufacturers are not obliged to insert INMETRO’s seal at the origin, being now allowed to insert the seal in Brazil, before marketing the devices. Also concerning INMETRO’s seal, in some cases for disposables and/or non-sterile devices, the seal can now be attached to the packaging only, and not the device itself.

In addition, the new Ordinance 384/2020 instated that INMETRO certificates, issued under the new regulation, will not expire after 5 years (as the previous Ordinance 54/2016). The certificates will require maintenances to be carried out properly every 15 months.

It is worth mentioning that the new Ordinance defines applicable requirements that must be met to allow the new possibilities to apply.

During the next 6 months, maintenance process, audits and recertifications can still be carried out through Ordinance 54/2016, however, they must be revised according to Ordinance 384/2020 on the next maintenance. For existing certificates issued according to Ordinance 350/2010 though, maintenance process and audits can be performed according to Ordinance 350/2010 until the end of the 5 year’s certificate validity.

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DOMO Salute Team

O post INMETRO’s new Ordinance 384/2020 has brought new alternatives for conformity assessment apareceu primeiro em Domo Salute.

According to Resolution No. 185/ 2001, a medical device is a health equipment, apparatus, material, or system of medical, dental or laboratory use, designed for the prevention, diagnosis, treatment, rehabilitation or conception and which do not uses pharmacological, immunological or metabolic means to perform its main function in human beings but can be assisted in their functions by such means.

Therefore, ANVISA included 33 new items to the list, and informed that those which had been previously registered will be cancelled. Some of the products are:

• Pliers and scissors for cutting nails;
• Wheelchair cushions, except for ulcer prevention;
• Bib for dental use;
• Trays / Boxes / Cases, including for sterilization (Labels to identify boxes / racks);
• Pen for surgical marking;
• Device that destroys and disables a medical device / counter (needles, scalpels, and others);
• Packaging for sterilizing medical products;
• Organ transport and storage packaging;
• Canvas / device / field for patient transfer;
• Gloves with no indication of health use;
• Nipple protector;
• Patient identification bracelets (including mother-child bracelets) and risk classification bracelets,
• Restrictors used to contain the patient;
• Disposable hospital bedding;

The full list contains 9 categories of products and is available here.

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DOMO Salute Team

O post ANVISA adds 33 products to the list of exempted healthcare products apareceu primeiro em Domo Salute.

Last year (March 1st) ANVISA had established the NOTIFICATION route for Risk Class I devices through RDC 270/2019. Under the new Resolution, risk classes I and II will undergo a simplified process that does not require ANVISA to technically analyze the device prior to granting the registration.

The changes in the regulation have no impact on the productive sector, since there will be no changes in the way petitions are applied, nor in the necessary documentation. Since NOTIFICATION processes take up to 30 days after the application, RDC 423/2020’s publication will allow greater balance and agility in the analysis of products with higher risk, as well as less time for products with lower risk to reach the Brazilian market.

As previously mentioned, the documentation required and the technical requirements for Risk Class II products remain the same. However, it is important that companies are attentive to possible requests for additional information in cases of processes that undergo documentary audit or procedural review. In these cases, ANVISA will send communications directly to the companies, establishing a deadline for them to reply.

DOMO’s team is working to keep clients and community updated on the latest moves from Brazilian Regulatory Agencies, follow us on social media to get an update on the top news regarding the Brazilian regulatory system.

DOMO Salute Team

O post ANVISA publishes RDC 423/2020 extinguishing the CADASTRO route apareceu primeiro em Domo Salute.

One of the platforms is the Post-Market Monitoring of the quality of Covid-19 related devices subject to health surveillance, which provides data on products that are or have been in an irregular situation.

The issues might be related to unsatisfactory performance on tested products, lack of Good Manufacturing Practices Certification (CBPF) or of the local ANVISA Operating Permit  (AFE), absence of registration, irregular labelling, amongst others.

The panel shows products divided into categories (medical devices, IVD, sanitizers and cosmetics), and brings informations such as the name of the company, product and actions taken.

Anvisa clarifies that, if the company complies with the rules and solves the problem detected, the measures can be revoked. For this reason, the panel also has information on the status of the product and a link to the publication of the measure adopted.

According to data available on the platform until August 26, most of the products targeted by restrictive measures were cosmetics (43.27%), such as hand sanitizers. Next are sanitizers (33.65%), IVD (17.31%) and other medical devices (5.77%).

There is also another panel solely with data from the Post-market Monitoring of the quality of Covid-19 IVDs achieved through laboratory analyzes. The data comes from a partnership established between ANVISA and the National Institute for Quality Control in Health (INCQS).

The goal is to assess, through laboratory tests, the accuracy and precision of  IVDs being marketed in the country, in order to guarantee the safety and effectiveness of diagnostic tests.

After ANVISA and the INCQS’ evaluation the following measures can be adopted: precautionary interdiction (preventive action); suspension of manufacture, commercialization, distribution, import and use; apprehension, destruction and withdrawal.

The panel provides organized data on the number of analyzes performed, results obtained and precautionary measures adopted. There is also a table with the commercial name of the device, the manufacturer’s identification, the number of the analyzed batch(s), the type of the report and its date of issue.

Of the 216 samples analyzed until August 26, 134 products were in compliance with the expected performance. Another 82 did not perform according to what was claimed by the supplier, being classified as “non-compliant”.

Routinely, the analytical data obtained from monitoring diagnostic tests and the measures adopted by ANVISA are updated on the public Analytical Panel. The list of regularized products is also updated daily.

According to the current rules, previous laboratory tests are not carried out by ANVISA or the INCQS before the Registration is granted. The Holder is responsible for the information provided and the production control must follow the precepts of Good Manufacturing Practices (BGMP).

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DOMO Salute Team

O post Covid-19 Post market surveillance apareceu primeiro em Domo Salute.

RDC 346/2020, published in March, was originally valid for 180 days. With this new Resolution, RDC 346/2020 will now be valid for as long as the Public Health Emergency, declared by the Ministry of Health in February (Ordinance nº 188), is in force.

Under the terms of the Resolution, temporary and emergency use of information from Foreign Regulatory Authorities is allowed to replace Health Inspections carried out by ANVISA.

In addition, the emergency use of remote inspection mechanisms are temporary allowed, replacing the on-site sanitary inspection for purposes of obtaining GMP Certification. Although it is not yet being practiced by ANVISA, remote inspections may be carried out by means of videoconferencing technologies and data transmission to verify compliance with the GMP.

Good Manufacturing Practices Certifications granted under the terms of the Resolution will be valid for two years, counting from the publication date in the Brazilian Official Gazette (DOU).

In case the manufacturer can’t comply with the terms previously described, a tem­porary GMP Certificate can be granted if:

*      The medical device is used in cases of serious health risk for the control, diagnosis, prevention or treatment to meet the health needs caused by Covid-19 and;

*      It is an essential product to maintain life whose availability is threatened by shortages (imminent or installed) in the national market due to the pandemic and;

*      GMP Certificate is the only impediment to the registration and commercialization of the product.

It is still necessary to present technical documentation and ANVISA’s fee will be still applicable.

The Certificate granted under those terms will be valid for 180 days. After the temporary certification is over, ANVISA must adopt, on a priority basis, the conventional certification mechanisms.

Domo team is working to keep clients and the community updated on the latest moves from Brazilian Regulatory Agencies, and working closely with ANVISA and INMETRO. Therefore, we have made available for Download a complete overview on the actions taken by the Agencies.

Click here to download “An Overview on Brazilian Regulatory Agencies’ temporary measures to enable market

access of COVID-19 related medical devices”.

Follow us on social media to get an update on the top news regarding the Brazilian regulatory system.

DOMO Salute Team

O post RDC Nº 346/2020 validity extended apareceu primeiro em Domo Salute.

Alterations, as defined by ANVISA, are changes on the information presented to ANVISA in the process of medical device’s registration. The new regulation classified those alterations in three categories, according to the type of change requested and the devices’ risk for health:

• Approval required Alterations
• Alterations with immediate implementation
• Non-reportable Alterations

Approval required Alterations

Alterations considered to be of greater health relevance, which deal with changes to be introduced in the regularization process, authorized only after technical document analysis and the issuance ANVISA’s approval.

Examples of approval required alterations are:

• Changes in the indication of use; type of operator or patient or use environment;
• Changes in the operation principle;
• Alteration or inclusion of resources;
• Addition of new models in a family;
• Alteration or addition of a new manufacturing unit in the Registro;
• Clinical performance;
• Manufacturing process, etc. 

Alterations with immediate implementation

Alterations classified as of medium sanitary relevance, that deal with changes to be introduced in the regularization process. Their implementation is authorized in the national territory upon petition protocol before ANVISA.

Immediate implementation changes will be published on ANVISA’s website, within 30 (thirty) days from the petition, regardless of document analysis.

Although the alterations with immediate implementation do not require ANVISA’s evaluation, the petition may be subject to documentary or technical assessment at any time and, if necessary, additional information or clarifications may be requested.

Examples of immediate implementation changes are:

• Change on the commercial name;
• Changes on contraindications;
• Adverse effects; warnings or precautions;
• Alteration or addition of a new manufacturing unit in the Notification or Cadastro;
• Company name for foreign manufacturers, etc.

The request for changes to Risk Class I medical devices will be carried out under the immediate implementation regime, except in the case of changes classified as non-reportable alterations.

Non-reportable alterations

Any other change of lesser sanitary relevance, resulting from a change that is not classified as required approval or immediate implementation, and that does not depend on a protocol at ANVISA for implementation.

Examples of non-reportable changes are:

• Non-technical changes such as images, formatting, layouts, symbols and text adaptations of documents without adding risk;
• Updates to Company Operation Authorization information;
• Changes to company contact and website;
• Alteration of technical assistance;
• Bug fixes in software, etc.,

Non-reportable changes must be controlled by the Brazilian Registration Holder’s Quality System, and be incorporated in subsequent petitions. 

Monitoring

According to the General Management of Medical Devices’ Technology (GGTPS), audits will be conducted focused on petitions for Alterations with immediate implementation. The goal will be to identify deviations and inconsistencies, working with companies to provide the necessary adjustments, when necessary. It is important to highlight that any alterations must comply with the rules of good manufacturing practices.

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DOMO Salute Team

O post ANVISA: Alterations on your regularized medical device apareceu primeiro em Domo Salute.

The report shows that the Agency has achieved good results and an increasing number of medical devices registered, comparing to the previous year, and the lowest timeframe from the registration application to the final publication in 10 years. The good results in terms of deadlines can be attributed, in part, to the greater availability of the technical evaluation teams, since Risk Class I products started to undergo a Notification path, which does not require ANVISA’s technical evaluation. Learn more from our post about Notification.

Moreover, the report brings important data about the MDSAP program, which represented approximately 45% of the Good Manufacturing Practices certificates in foreign manufacturing plants issued by ANVISA in 2019. That suggests optimistic perspectives for the world’s regulatory convergence, a movement in which ANVISA aims to participate in a leading role.

DOMO’s Team has evaluated the report and summarized the highlights and key results achieved by the agency regarding medical devices:

21 medical devices approved per day

The Management Report highlights that in 2019 approximately 7,800 new medical devices were approved/registered  by ANVISA. The requests were distributed as follows: 200 orthopedic implants, 5,000 materials, 1,400 in vitro diagnostic devices and 1,300 equipment. The amount of new regularized products corresponded to the regularization of approximately 21 new devices per day. In addition to the large volume of approvals granted, the number also represented an important growth – increasing 35% when compared to 2018.

Brazilian Good Manufacturing Practice Certification

During 2019, 415 Good Manufacturing Practices (BGMP) application processes for medical device manufacturing plants were submitted to ANVISA through the regular procedure (in which ANVISA itself conducts technical inspection to ensure compliance with requirements), and 359 processes were requested to ANVISA via Medical Device Single Audit Program (MDSAP).

The MDSAP is a way through which medical device manufacturers can be audited once to be in compliance with the standard and regulatory requirements of the participants medical device markets. The main goal is to promote more efficient and flexible use of regulatory resources through worksharing and mutual acceptance among regulators while respecting the sovereignty of each authority.

According to ANVISA, with the increasing number of companies participating in the program, the Brazilian Agency was able to carry out a smaller number of international inspections, guaranteeing the efficient use of public money. In addition to saving resources, the MDSAP represents an increase in the sanitary safety of medical devices, since the auditing bodies inspect companies more frequently, sending annual reports to the Agency and to the other authorities participating in the program.

A total number of 462 BGMP certifications were granted by regular means (on-site inspection by ANVISA) to foreign manufacturers, while 48 had their application rejected. In addition, 374 certifications were granted through the MDSAP program, and only 2 requests were rejected. It is worth mentioning that automatic renewals granted are included in the amounts mentioned.

Deadlines and average time

The average time for the first manifestation from ANVISA in the processes during 2019 was of 36.88 days, or the lowest since 2009. The average time for the result’s publication for requests in 2019 was around 79 days, this being the second lowest average time since 2009.

Post-Market Surveillance

The surveillance of adverse events (harmful reactions to health, which occur under normal conditions of use, abuse or misuse) and technical complaints (notifications of suspected alteration or irregularity of a product or company in technical or legal aspects) in the post-use, or post-marketing, has as fundamental objective the early detection of problems related to use, aiming to trigger measures so that the risk is eliminated or minimized.

ANVISA received 15,224 technical complaints through the NOTIVISA system. The majority (92.47%) refer to materials, while 4.46% were related to medical equipment and 3.07% to IVD products.

Among the 3,286 adverse event notifications received, the majority were also related to materials (69.2%), and 30.8% to medical equipment.

It is worth noting that in numbers, the data related to post-market surveillance did not show a great variation, when compared to data collected by ANVISA in 2018.

Field Actions are carried out by manufacturers or medical device’s registration holders in order to reduce the risk of adverse events related to the use of products already on the market. Throughout 2019, 1,026 Field Action reports were received, which can be initial, monitoring and completion reports. Initial Field Action reports are evaluated and posted on ANVISA’s website in the form of Post-Market Surveillance Sanitary Alerts. In 2019, 356 alerts were released.

They are available here for public consultation.

New Regulatory Model

A new regulatory model – that aims to improve and qualify the country’s health standards has been into force since April 1st, 2019. The model, called the Regulatory Cycle and supported by Ordinance No. 1,741, has several advantages: it promotes changes in dealing with the preparation and review of regulatory acts, contributes to improving the planning and organization of regulatory processes; encourages the use of technical-scientific evidence; expands and values ​​the engagement of society.

Regulatory stock management

Managing the regulatory stock means organizing the current rules, monitoring their effectiveness and generating inputs for their review. The main goal is making the stock more efficient, rational, clear and understandable. During 2019, 103 standards were incorporated, while 227 were withdrawn from ANVISA’s regulatory stock. Most of these were eliminated through the action known as “Regulatory Guillotine”. Learn more about that here.

Click here to download 2019 Management Report (Portuguese only).

Click here to check ANVISA’s Management Report summary folder 2019 (Portuguese only).

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DOMO Salute Team

O post ANVISA’s special report: 2019 results apareceu primeiro em Domo Salute.

Remote auditing is one of the audit methods described in ISO 19011:2018 Annex A1. The value of this method resides in its potential to provide flexibility to achieve the audit objectives. In order to accomplish that, all interested parties should be aware of their role in the process, inputs, expected outputs, risks and opportunities that will provide the basis to achieve the audit and audit program objectives.

The feasibility of remote audits using Information and Communication Technology (ICT) in accordance with ISO 19011:2018 should be considered when establishing the audit program. It is important to verify the adequacy of resources required to ensure an effective audit outcome. ISO 19011 – Annex A.1 provides several examples for the application of remote audit methods in combination with on-site methods, such as: “Remote audits refer to the use of ICT to gather information, interview an auditee, etc., when “face-to-face” methods are not possible or desired.”

IIAF MD 4 is another mandatory document for the use of ICT for audit/assessment purposes. It defines the rules that certification bodies and their auditors shall follow to ensure that ICT are used to optimize the efficiency and effectiveness of the audit/assessment, while supporting and maintaining the integrity of the audit process. Both ISO 19011 and IAF MD 4 should be known and considered by the auditors.

The ICT resources open the opportunity to audit sites and people remotely, shortening distances, reducing travel time, costs, and associated environmental impact , adapting audits to different organizational models. ICT can help increasing the size or quality of sampling in the audit process, when prepared, validated and used properly. Using video cameras, smart phones, tablets, drones or satellite image to verify physical settings such as pipe identification in the petroleum industry, machinery settings, storage areas, production processes or forest or agricultural sites, for example. Those resources have definitely transformed the way we work.

However, we must consider the limitations and risks posed by ICT in the fulfilment of audit objectives, such as information security, data protection and confidentiality issues, veracity and quality of the objective evidence collected, amongst others.

How are the Brazilian Regulatory Agencies dealing with this?

Due to the COVID-19 pandemic, all Notified Bodies accredited by CGCRE (INMETRO General Coordination for Accreditation) as a Certification Body (CB) for the local INMETRO-scheme to conduct medical devices approvals for Brazil are allowed to perform remote audits until the 30^th of June, according to  INMETRO Ordinance 111:2020. The reshaped Ordinance will allow INMETRO medical devices certification for factories to be carried out anywhere in the world, making the process faster and more practical. But INMETRO’s Ordinance 111:2020 also postponed all certification deadlines in 06 months. So far almost all CBs in Brazil are using this 06-month deadline for internal adjustments, the majority did not have ICTs resources available, trained auditors and internal procedures to provide remote audits.

ANVISA’s RDC 346/2020, published on the 13^th of March, stablished that the emergency use of remote inspection mechanisms will be temporary allowed (while the Resolution is in force – 180 days), replacing the on-site sanitary inspection for purposes of obtaining Brazilian Good Manufacturing Practices (GMP) Certification. Remote inspections are carried out by means of videoconferencing technologies and data transmission to verify compliance with the GMP.

At first, the alternative and temporary certification mechanisms described in the Resolution apply only to petitions submitted prior to the publication of this Resolution, with the exception of the request for GMP certification for medicines or medical devices intended for control, diagnosis, prevention or treatment of  the new Coronavirus OR essential products to maintain life. However, Resolution nº 385/2020, published on May 12^th removed that restriction and opened the possibility of remote audits for other products and for petitions submitted after RDC 346/2020, while the Resolution is in force.

Therefore, ANVISA has taken actions to be aligned with this new reality concerning Certificate issuance for factories entering the Brazilian market during the 180 days-period established by RDC 346/2020. Moreover, they kept open the possibility of renewing those measures for equal and successive periods of 180 days, in case inspections by ANVISA are still unviable due to the pandemic scenario. INMETRO and ANVISA remote audits are likely to be more frequent in the coming months, but one big question remains. After the pandemic the Brazilian Regulatory Agencies will continue to authorize the use of remote audits? DOMO Salute team will remain attentive on the Brazilian Regulatory Agencies movements.

Follow us on social media to get an update on the top news regarding the Brazilian regulatory system.

This article was written by our Business Developer Maurício Avila. Maurício is a lead auditor for ISO13485 and MDSAP, through his career he has engaged in product certification and the standardization area, building up a deep understanding of the regulatory paths foreign companies can face entering the Brazilian market.

O post Are Remote Audits an option when accessing the Brazilian medical device market? apareceu primeiro em Domo Salute.

The regulations include new temporary regulatory pathways to speed up market access to ventilators, face masks and PPE, test kits, and others.

ANVISA recently launched the Business Intelligence (BI) platform, which presents the full line of IVD products for Covid-19 and the status of requests filed at the Agency. The platform makes it possible to access various data, such as the number of registries granted, rejected, under analysis, awaiting the certificate of Good Manufacturing Practices (BGMP), among others.

DOMO Salute is committed to fulfilling our role in the society and working hard to bring quality health solutions closer to people everywhere.

We are working to keep our clients and community updated on the latest moves from Brazilian Regulatory Agencies, and working closely with ANVISA and INMETRO. Therefore, we are making available for Download a complete overview on the actions taken by the Agencies so far.

Click here to download “An Overview on Brazilian Regulatory Agencies’ temporary measures to enable market

access of COVID-19 related medical devices”.

Count on us to navigate through unstable sea. Stay safe and healthy.

DOMO Salute’s team

O post Brazilian Regulatory Agencies & Covid-19 apareceu primeiro em Domo Salute.

INMETRO published, on the 27^th of March, Ordinance nº 111, regarding extraordinary and temporary procedures for Conformity Assessments, due to the international public health emergency resulting from the new Coronavirus.

The Ordinance establishes alternative conditions for Product Certification Bodies (CBs) to carry out Conformity Assessment activities in manufacturing plants located in countries affected by the coronavirus epidemic (COVID-19), including Brazil.

The Ordinance is only applicable for processes initiated between January 1^st 2020 and June 30^th  2020. For maintenance or recertifications processes, the regulation is effective only if the maintenance/expiration date of the certificate or registration is within the informed period.

For maintenance and recertification processes, the CB shall perform a risk analysis based on the records of the latest internal audits, top management´s critical analysis and complaints handling, as well as the history of non-conformities in testing. After the analysis, the CB may take the decision to postpone the maintenance or recertification audit.

In the event of the postponement, the Audit must necessarily be carried out within a maximum period of 6 (six) months, counting from the date on which the decision is registered by the CB. Alternatively, based on the risk analysis and considering the existence of adequate conditions, the CB may decide to perform a remote audit.

In the case of remote auditing, the initial, maintenance or recertification audit activity may be performed, at the CB’s discretion, dismissing the need for in house audit or scheduling a subsequent in house audit to confirm the certification. If the risk analysis does not support the audit’s postponement or if the operating conditions of the factory do not support the performance of remote auditing, the certificate must be suspended.

Regarding testing and test reports, Ordinance 111 gives the possibility for tests to be performed by the manufacturer in 1st or 3rd party laboratories accredited in Brazil or abroad, within the scope of the ILAC Mutual Recognition Arrangement (ILAC MRA), regardless of the lab acceptance criteria provided in the medical device specific Conformity Assessment Requirements.

Regardless of the extraordinary conditions, technical requirements provided for in the regulations published by INMETRO must continue to be complied with by manufacturers.

Follow us on social media to get an update on the top news regarding the Brazilian regulatory system.

DOMO Salute Team

O post INMETRO’s temporary procedures facing the new Coronavirus apareceu primeiro em Domo Salute.

Our team prepared a few highlights with important changes:

* The manufacture and import of surgical masks, N95, PFF2 or equivalent particulate respirators, goggles, face shields, disposable hospital garments (waterproof and non-waterproof aprons / cloaks), caps and props, valves, respiratory circuits and connections for use in health services, they are exceptionally and temporarily exempt from ANVISA Authorization for Company Operation (AFE), from Notification to ANVISA, as well as from other health authorizations.

* The purchase of new and not yet regularized by ANVISA personal protective equipments, pulmonary ventilators, respiratory circuits, connections and valves, parametric monitors and other medical devices essential to combat the COVID-19 pandemic, by public and private bodies and entities as well as health services, is as long as they have been previously regularized and marketed in a jurisdiction member of the International Medical Device Regulators Forum (IMDRF). It is only  temporarily allowed when similar devices regulated by Anvisa are not available.

Specific requirements that must be met for each device is detailed in the Resolution. The Resolution comes into force immediately and will be valid for 180 days.

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DOMO Salute Team

O post New temporary procedures for the manufacture, import and acquisition of strategic medical devices announced to fight the new Coronavirus apareceu primeiro em Domo Salute.

Our team prepared a few highlights with important changes:

* For situations in which the manufacturing company does not have the Good Manufacturing Practices Certification issued by ANVISA, Medical Device Single Audit Program (MDSAP) or ISO 13485 Quality Management System Certification will be exceptionally accepted.

* The proof of registration, free trade certificate or equivalent document, can be replaced by a simple statement issued by the Legal and Technical Responsible of the requesting company informing that the product in question is regulated and marketed in a jurisdiction member of the International Medical Device Regulators Forum (IMDRF) .

* Exceptionally, products covered by this Resolution are exempt from certification under the Brazilian Conformity Assessment System (SBAC).

* Registrations granted under the terms of the Resolution will be valid for 1 (one) year from the publication date in the Federal Official Gazette.

* For products subject to this Resolution, necessary declarations for Cadastro and Notification petitions are exempt from consularization or apostille.

* Requests for medical devices’ registration referred to in this Resolution will be analyzed in priority, overriding the chronological criteria.

Regularization may be granted in accordance with this Resolution, when the indication of use is identified to preventing or treating diseases caused by the new Coronavirus (COVID-19). The Resolution comes into force immediately and will be valid for 180 days.

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DOMO Salute Team

O post Temporary procedures for personal protective equipments, pulmonary ventilators and strategic medical devices regularization in Brazil announced to fight the new Coronavirus  apareceu primeiro em Domo Salute.

Last Thursday (03/12/2020) ANVISA published an update regarding IVD products for Covid-19 diagnosis aiming to speed products regularization and the offer of diagnostics.

ANVISA will prioritize the analysis of all processes related to products for Covid-19 diagnosis and other agents that cause respiratory infections.

The measure aims to expand access to IVDs and support health professionals in identifying positive cases.

Brazil has declared public health emergency through the Ministry of Health.

Alternatives to GMP certification: RDC Nº 346/2020

Last Friday (03/13/2020) ANVISA published RDC Nº 346/2020, which defines extraordinary and temporary criteria and procedures for GMP Certification, for the purposes of registration and post-registration changes to active pharmaceutical ingredients, medicines and medical devices, due to the international public health emergency of the new Coronavirus.

Under the terms of the new Resolution, temporary and emergency use of information from Foreign Regulatory Authorities is allowed to replace Health Inspections carried out by ANVISA. According to the Resolution, Foreign Regulatory Authority members of the MDSAP (Medical Device Single Audit Program) are the ones entitled to share information for certifications related to medical devices.

In addition, while the Resolution is in force (180 days), the emergency use of remote inspection mechanisms will be temporary allowed, replacing the on-site sanitary inspection for purposes of obtaining GMP Certification. Remote inspections are carried out by means of videoconferencing technologies and data transmission to verify compliance with the GMP. Moreover, remote inspections replace the need for inspectors to be physically present at the productive plant.

Good Manufacturing Practices Certifications granted under the terms of the Resolution will be valid for two years, counting from the publication date in the Brazilian Official Gazette (DOU).

The alternative and temporary certification mechanisms described in the Resolution apply only to petitions submitted prior to the publication of this Resolution, with the exception of the request for GMP certification for medicines or medical devices intended for control, diagnosis, prevention or treatment of  the new Coronavirus OR essential products to maintain life, when the availability is threatened by shortages (imminent or installed) in the national market motivated by reason proven to be linked to the new Coronavirus.

It is important to highlight that the Resolution can be renewed for equal and successive periods of 180 days in case inspections by ANVISA are still unviable due to the pandemic.

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DOMO Salute Team

O post ANVISA’S measures on medical devices during the Covid-19 Pandemic apareceu primeiro em Domo Salute.

According to the Normative Instruction, foreign companies must open a National Corporate Taxpayer Registry (CNPJ) in Brazil only in case of winning the bidding process. Therefore, foreign suppliers can freely participate in the bids, only needing to constitute a legal representative in the country in the execution of the contract.

To participate in a national public bidding process, the only requirement will be the inclusion of the foreign company in the Unified Supplier Registration System (SICAF).

The measure, informed the ministry, will affect 99% of the public procurement processes of the Federal Executive Branch, including purchases of common goods and services, currently carried out through electronic trading.

In September, the government had removed the sworn translation requirement for the SICAF’s registration of the foreign company. According to Decree 10,024 / 2019, the requirements for qualification with free translation are now accepted for joining the System. Only if the winner of the bid is a foreigner, sworn translation will be mandatory for the signing of the Contract or the Price Registration Draft.

Public purchases by the federal government are carried out through the portal Comprasnet. With the new rules, it will be possible to access the system and register for tenders anywhere in the world. The bidding platform will be translated into English in the near future, to facilitate the participation of international suppliers.

During the World Economic Forum, in Davos, Switzerland, in January, the Minister of Economy, Paulo Guedes, had announced the intention of Brazil to adhere to the Public Procurement Agreement (GPA) of the World Trade Organization (WTO). With 48 member countries so far, GPA aims to promote the mutual opening of government purchases (made by the public sector), regardless of origin, imposition of barriers for imported items or preference margin for domestic products.

In Brazil, according to data from the Brazilian Institute of Geography and Statistics (IBGE) from the year 2012, health expenditures represented around 8.8% of the Gross Domestic Product. The distribution of government spheres in health service financing distributed by 47.8% at the federal level, 21.41% at the state level and 30.8% at the municipal level. In 2012, the public sector in Brazil represented around 42% of health spending.

In addition, data from the year 2015 showed that the public sector was then responsible for 36% of the total 450 thousand hospital beds. Nowadays, 46% of the Health System is supported by the Government through the Unified Health System.

The recent changes represent huge business opportunities for foreign companies wishing to enter the Brazilian market. In order to market medical devices in Brazil companies must be in compliance with ANVISA and possibly other Brazilian Regulatory Bodies.

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Font: Agência Brasil

DOMO Salute Team

O post Foreign participation in Brazilian public tenders becomes more simple apareceu primeiro em Domo Salute.

Audits are conducted by Auditing Organizations authorized by the participating Regulatory Authorities to audit under MDSAP requirements. The audit is performed based on ISO 13485, plus the country in which the certification is being applied specific regulatory requirements. The MDSAP is a way through which medical device manufacturers can be audited once to be in compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States. The main goal is to promote more efficient and flexible use of regulatory resources through worksharing and mutual acceptance among regulators while respecting the sovereignty of each authority.

Since 2017 the Brazilian medical device market regulator ANVISA recognizes Auditing Organizations and up to now a sum of 13 bodies are officially authorized to perform audits that include Brazilian GMP’s requirements in their scope. The updated list of Auditing Organizations is available here. (link in Portuguese).

A report from the end of 2019, released by ANVISA, shows a significant increase in medical device manufacturers participating in the MDSAP, reporting that 48,7% of all international GMP certificates issued by ANVISA in 2019 were through MDSAP audit. It is the largest number of participating companies since the beginning of the program, in 2015.

In addition to saving resources, ANVISA reports that the MDSAP program represents an increase in the health security of medical devices, as the auditing bodies inspect companies more frequently, sending reports annually to the Agency and the other authorities participating in the Program.

Doubts about joining the MDSAP Program to get a BGMP certificate? Do not hesitate in contacting our experts! Follow us on social media to get an update on the top news regarding the Brazilian regulatory system.

DOMO Salute Team

O post Using the MDSAP Program to enter the Brazilian Market apareceu primeiro em Domo Salute.

The Agency aims to develop a new regulatory model exclusively for the virtual and disruptive context of medical software, to be in alignment with international regulatory bodies, to make developers aware of regularization and to bring cybersecurity regulation on connected devices.

The Report is the result of work that was foreseen in the Regulatory Agenda – 2017, and has been carried out since 2018, to identify and compare regulatory options for regularizing software as medical devices (SaMD), which, as defined by ANVISA, are those that “by themselves (without considering the hardware connection) are considered medical devices”. Examples are image processing software for diagnostics, health diagnostics software, radiotherapy planning software and even certain cell phone applications. In addition to these, there are still software that runs on medical devices. All of those, according to ANVISA, are called medical software.

Recent discussions in the scope of the International Medical Device Regulators Forum (IMDRF), of which Brazil is a part and works in synergy with concerning regulations, resulted in the creation of 5 Guides for the countries participating in the forum to build their regulations.

The regulatory alternatives were analyzed according to regulatory documents available in other countries (USA, Europe, Australia, Canada) and led the Agency to conclude that the best option available is the creation of a specific regulation for the area. The general plan is to publish a specific regulation for software and a Guide, which will clarify the scope and details of application of the new standard. ANVISA also highlights that the approach will keep in mind solutions that are less costly for companies in general.

The regulation is expected to be out for public consultation during the 1st trimester of 2020, with the publication of the final result expected for July 2020. The Guide (clarifying the scope of the standard) and Webinar should be carried out after, with a deadline for the third trimester of 2020.

The full report is available and demonstrates the extensive research carried out by the Agency, through consultations with the sector, the general public, and a review of the international software as medical devices market and worldwide regulatory trends for the area.

Our team will be monitoring Brazilian regulatory trends. Follow us on social media to get an update on the top news regarding the Brazilian regulatory system.

DOMO Salute Team

O post ANVISA’s upcoming regulation on SaMD’s – Software as Medical Device – apareceu primeiro em Domo Salute.

The Guides express ANVISA’s understanding of best practices regarding procedures, routines and methods deemed appropriate to meet technical or administrative requirements by the Agency’s legislative and regulatory frameworks regarding clinical evaluation.

– They are non-normative regulatory instruments, of a non-binding and advisory nature –

Therefore, it is possible to use alternative approaches to the propositions set forth, provided they are compatible with the requirements related to the specific case. Failure to comply with the contents of the documents does not characterize a sanitary infraction, nor does it constitute grounds for rejecting petitions, provided that the requirements of the law are met.

The first Guide, which is titled Medical Device Clinical Evidence Guide – Concepts and Definitions, aims to provide information to assist in building clinical evidence to support the safety and efficacy of medical devices. The second Guide, which is titled Medical Device Clinical Investigation Guide, aims to provide information to assist in the design and conduct of clinical investigations. While the  third document, Clinical Medical Device Evaluation Guide, aims to provide information to assist in outlining the clinical evaluation of medical devices.

The recommendations contained in the Guides take effect from the date of their publication on the ANVISA Portal, but are open to receive suggestions from the company through an electronic form, available at:

https://pesquisa.anvisa.gov.br/index.php/22341?lang=pt-BR (Portuguese only).

Contributions received will be evaluated and may support the revision of the Guides and the consequent publication of a new version of the documents.

The documents were built from a working group within IMDRF, the world’s largest forum for medical device regulators. Through the implementation of them, ANVISA seeks to provide more accurate and deeply harmonized guidance on the regulatory guidelines that establish the need for proving the safety and efficacy of medical devices for registration in Brazil.

Join DOMO in reviewing and contributing with ANVISA! Our team is available to answer any questions regarding the Guides.

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DOMO Salute Team

O post ANVISA publishes IMDRF Guides for medical devices’ Clinical Evaluation apareceu primeiro em Domo Salute.

In order to approve and update the list of Technical Standards equipment under Health Surveillance must comply with, ANVISA published last November the Normative Instruction number 49, which came into effect immediately after the publication (22^nd November 2019). It is important to highlight that Normative Instructions No. 4  (September 24, 2015), No. 22 (October 20, 2017) and No. 29 (November 27, 2018) have been repealed from this date.

The new list of standards includes updates, additions, and deletions that must be considered for new medical device compliance certification processes (Notification, Cadastro, Registro, , alterations and revalidations).

Most of the additional standards are already in force, with some exceptions such as ISO 7176-1: 2018 and ISO 7176-15: 2009 concerning the determination of static stability and disclosure requirements, documentation and identification of Wheelchair and also IEC 60601-2-2: 2017 regarding the particular requirements for basic safety and essential performance of high frequency surgical equipment and accessories that will come into effect from December 1^st 2020. In addition, ABNT NBR ISO 7176-8: 2018 Standards for Wheelchair Static, Impact and Fatigue Test Requirements and Test Methods, IEC 60601-2-28: 2017 and IEC 60601-2-54: 2018 regarding specific requirements for basic safety and the essential performance of medical diagnostic X-ray tube assemblies as well as radiographic and radioscopic X-ray equipment will be effective only from December 1^st 2021.

You can access the regulation and the list of complete standards through the link:

Portal ANVISA

In case you have any questions regarding the new regulation, please do not hesitate in reaching out to us.

Our experienced team can meet your medical device certification project needs within INMETRO.

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DOMO Salute Team

O post Normative Instruction 49/2019 updates list of Technical Standards for medical device compliance certification apareceu primeiro em Domo Salute.

Updates regarding Definitions, Classification, Registration Pathways, Labeling and Instructions for Use requirements for Medical Devices and IVD Medical Devices

ANVISA has opened in last October the Public Consultation 730/2019 to discuss with the community updating RDC 185/2001, the standard that drives medical device registration in Brazil. The main goal of the proposed new resolution is the modernization of the Brazilian legislation as well as the regulatory convergence regarding medical devices’ classification rules to match the criteria stated in the European Medical Devices Regulation (MDR).

It was also published by ANVISA the Public Consultation 734/2019 which aims to discuss updates for RDC 36/2015, legislation related to IVDs registration, and it is also focused on regulatory convergence with international rules of classification.

DOMO experts prepared highlights concerning the changes being proposed in comparison to the current regulation (RDC 185/2001 and 36/2015):

• Stock depletion allowance to enable manufacturers selling previous versions of certain devices up to these products’ expiration dates, concomitantly with the commercialization of the new version.
• Provision for registration cancellation by ANVISA in case of cancellation proof of any of the documents that instructed the product’s regulation process.
• Provision for increased cooperation between MERCOSUR States Parties’ competent health authorities, so that an authority canceling or suspending medical devices registration must communicate the decision to other authorities, presenting technical justification.
• Inclusion of new definition terms in the legislation glossary, such as: cluster, aggregate, nanomaterial, particle, software as a Medical Device (SaMD), expansion of the definition of IVD Medical Devices.
• Updating existing risk classification rules and adding new rules, such as adding a software-specific rule and a device including nanomaterials-specific rule.
• Update of the Risk Class III and IV’s petition form (Annex IIIA).

ANVISA will accept comments on the new consultations for a 60-day period from their publication (up to the end of December).

We believe that the modernization of the legislations governing the registration of medical devices in Brazil is of paramount importance to keep ANVISA’s guidelines in line with worldwide guidelines. An effective participation and the inputs from the community are important mechanisms for the Agency to know the point of view of the regulated sector and help in building this new regulatory instrument.

Join in!

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DOMO Salute team

O post ANVISA’s Public Consultation nº 730/2019 and 734/2019 apareceu primeiro em Domo Salute.

We are proud to participate once again the world’s largest event for the medical sector – MEDICA 2019 – from November 18th to November 21st in Düsseldorf, Germany.

We’ll be at MEDICA 2019 to talk about how we’re helping medical device companies bring to market new products to Brazil, and discuss the key areas of opportunity that exist today in the Brazilian Market.

Brazil is the largest healthcare market in Latin America and spends 9.1 percent of its GDP in healthcare. For medical devices, the market size is approximately $10.5 billion. The consumption of healthcare products increased 13.3 percent in 2018 (Source: ABIMED). Approximately 80% of all medical products used in Brazilian hospitals are estimated to be imported.

The Brazilian Market holds good opportunities for foreign manufacturers, but it is important to be fully prepared. Our clients are challenged with:

· Understanding the rather complex Brazilian Regulatory System

· Knowing the paths a product will face entering the Brazilian market, as well as timetables and costs

· Managing costs of having an office in Brazil and/or finding the right holder for your Registry

· Developing a robust, secure technical dossier to comply with Brazilian Regulatory bodies

· A lack of expertise in addressing compliance

If these challenges ring a bell, we’d love to chat about how you’re solving them.

Book a meeting with us at MEDICA 2019 by reaching out at domosalute@domosalute.com.br

We look forward to meeting you.

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ANATEL – New regulation for Conformity Assessment and Homologation of Telecommunication Products

ANATEL approved on October 17^th, the new Regulations for Conformity Assessment and Homologation of Telecommunications Products.

The new Regulation institutes the end of fee charges for the homologation certificate’s issuance. The exemption from the fee is immediate and valid for all telecommunications products approved by ANATEL.

In the conformity assessment process, the equipment is subjected to verification of technical standards and laboratory tests that seek to ensure that they are properly tested and approved for use in Brazil.

The Regulations to which it refers shall enter into force within 180 days from the date of publication of the Resolution in the DOU (Brazilian Official Gazzete), except in relation to the obligations contained in Title IV and art. 58, concerning, respectively, the Market Surveillance Program and the exemption from the fees, which will enter into force on the date of publication of the new Resolution.

The changes, comparing it to the current regulation, concern the gratuity of the Homologation Fee, the Market Supervision Program, with the collection of samples made by the OCDs or ANATEL, and Certificates of Technical Compliance that will be issued only considering the applicant established regularly in the country.

Also, the Market Surveillance Program – where OCDS will collect samples directly from the market, according to procedure to be defined by ANATEL, came into effect with the publication. OCDs may also have Memorandum of Understanding with foreign Certification Bodies, as long as they are accredited by an accrediting Body recognized by INMETRO / ANATEL.

Petition Analysis Cycle Panel – ANVISA’s new online tool

ANVISA has recently made available on its website the Petition Analysis Cycle Panel, a tool that shows all the steps of the petition process, from the entry in the analysis queue to the moment the registrations and authorizations are finalized.

The purpose is to present, at various levels of analysis, the main stages and life cycle times of petition analysis.  With the aid of the new instrument, companies now have the opportunity to know the average and median deadlines for the granting of product registration and Business Operation Authorizations (AFEs).

ANVISA’s Webinar

ANVISA periodically hosts a Webinar – virtual seminars that bring updated content and knowledge to the public. This week, the Webinar addressed medical equipment’s registration main technical requirements. In addition, ANVISA presented the main reasons for medical equipment’s registration refusal and notification’s cancellation.

The purpose of the seminar was to explain the process of regularization of risk class I and II equipments according to Collegiate Board Resolution (RDC) 270/2019, RDC 40/2015 and Normative Instruction (IN) 22/2017, among other norms and understandings on the subject.

The recording of the seminar and comments made during the transmission are available in portuguese.

“20 years of Medical Device Regulation at ANVISA – next steps”

Registration is now open for participation in the Regulatory Dialogue “20 years of Medical Device Regulation at ANVISA – next steps”. The activity will be held next November 6, in Brasilia. The program of the event includes the discussion of topics such as advances and regulatory perspectives in the country, highlighting the challenges related to custom-made medical devices, software and product’s cybersecurity.

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DOMO Salute Team

O post Brazilian Regulatory System – News Roundup apareceu primeiro em Domo Salute.

Throughout 2019 we have had significant progress regarding medical devices within ANVISA, with the implementation of electronic petitions and protocols for primary and secondary processes. However, only 19% percent of all ANVISA’s services are currently digital, and 35% digital or partially digital. The goal is to achieve 75% of all services by 2020. ANVISA’s CEO, William Dib, states that the novelty signals a change in the way the Agency interacts and provides services.

It’s beyond technology, it creates savings and opportunities to review work processes in an integrated manner to better meet the needs of users and citizens, while optimizing the services of our technicians. – emphasizes Dib.

Luis Felipe Monteiro, secretary of digital government, noted that the digital plan is crucial to the Brazilian population. “The government has to be simple and available to citizens, 24 hours a day. ANVISA takes here an important step in its modernization”.

The mission of the project is to facilitate citizen access to information and services offered by the Agency.

Out of 180 services offered by Anvisa, the Digital Plan includes a transformation of 120 of them to digital format by 2020. The schedule was divided into two stages. The first will have 62 services implemented by the end of 2019. The second will have 58 digital services by the end of 2020.

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DOMO Salute Team

O post ANVISA’s Digital Plan apareceu primeiro em Domo Salute.

The new regulation distinguishes four terms regarding custom-made products and categories: Personalized medical devices (Dispositivo médico personalizado), Adaptable medical devices (Dispositivo médico adaptável), Patient-specific medical devices (Dispositivo médico paciente-específico) and custom-made medical devices (Dispositivo médico sob medida) as detailed above:

Personalized medical devices (Dispositivo médico personalizado): generic term to describe any type of medical devices intended for use by particular individuals, which may be custom-made devices, patient-specific medical devices or adaptable medical devices.

Custom-made medical devices (Dispositivo médico sob medida): intended exclusively for use by particular individuals, and manufactured specifically according to an authorized healthcare professional. The professional is responsible for specific design features, even in cases where a project can be developed in collaboration with the device manufacturer. Such product is intended to meet a specific anatomical or physiological condition or condition of a particular individual.

Adaptable medical devices (Dispositivo médico adaptável): mass-produced devices that undergo adaption, adjustment, fitting or molding based on a manufacturer’s instructions at the point of care to address a patient’s particular anatomic and physiological characteristics before use.

Patient-specific medical devices (Dispositivo médico paciente-específico): devices made compatible to a patient’s anatomy via anatomical reference sizing techniques, or using anatomical features obtained from imaging examinations. They are typically batch-produced through a process that can be validated and reproduced, under the responsibility of the manufacturer even if the project can be developed in collaboration with a qualified healthcare professional.

According to the new regulation, adaptable medical devices and patient-specific medical devices must undergo ANVISA’s regulation according to the criteria established by Resolutions RDC nº 185/2001 and nº 40/2015, and other current regulations. Therefore, these products must comply with regulations previously established for regular products (not custom-made).  Manufacturers and importers of patient-specific medical devices will have twenty-four months to adapt, counting from the date when the new regulation comes into effect.

Custom-made medical devices are subject to pre-market health control through a different mechanism than regular products. This procedure will be done through two steps: the first is a consent that ANVISA issues to the manufacturer or importer to be able to manufacture or import custom-made devices (Anuência à fabricação ou importação); the second is the notification that the manufacturer or importer has to request ANVISA prior to starting the manufacturing or import of each device (Notificação de fabricação ou importação).

According to the resolution, the national manufacturer or importer of custom-made medical devices must be in compliance with the Health Surveillance. Manufacturers and importers of Class III and IV products must file with ANVISA (one-time only) a request for consent to manufacture or import medical device tailored to each manufacturing unit. In order to do that, the product manufacturer needs Good Manufacturing Practices certification valid for the device’s risk class, as well as proof of valid ANVISA registration of devices manufactured on a commercial scale, in the same factory, with the same risk class and indication of use of the custom-made device. The consent request will be reviewed by ANVISA and the decision will be published on ANVISA’s portal and through electronic letter.

After obtaining the consent letter, the consent holder has to notify ANVISA at least 30 days prior to Risk Class III and/or IV custom-made devices’ manufacture or importation. The notification includes information regarding the product, the prescriber and the patient for which the custom product is intended, as well as technical justification for using the custom product instead of existing therapeutic alternatives registered by ANVISA. In addition, the national manufacturer or importer must keep a dossier for each device, including complete product documentation, as well as detailed case description, pathology and justification for the use of a custom-made device. The dossier must be kept filed within the company for a period of fifteen years from the date of manufacture, in case of implantable products, and five years for non-implantable products.

It’s important to highlight that the resolution does not apply to active medical devices, in vitro diagnostic medical devices (IVDs), medical devices for clinical trials, custom-made products tailored by technical orthopedics and footwear manufacturers, and dental prosthesis services provided by qualified professional.

Please let us know if you have any questions or concerns.

Check the full Resolution. (http://www.in.gov.br/en/web/dou/-/resolucao-rdc-n-305-de-24-de-setembro-de-2019-218018815)

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DOMO Salute Team

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ANVISA

Central de Atendimento / Call Center

The phone number 0800 642 9782 is available on weekdays from 7h30 to 19h30 (except for holidays). General information about ANVISA’s services are immediately available through their database that contains a variety of the most common queries. In case the information needed isn’t available, ANVISA will provide the answer within 15 working days.

The information available on ANVISA’s database is also accessible on their website.

Webchat

Webchats were recently made available by ANVISA and can be used to reach out to ANVISA online and get prompt answers. The service is available on weekdays, from 7h30 to 19h30, and it is recommended for general queries.  In case the information needed isn’t available, ANVISA will provide the answer within 15 working days.

Formulário Eletrônico / Contact Form

Using the Contact Form on their website is recommended for specific/technical queries. The form allows you to attach files related to your query in order to clarify technical issues with ANVISA technical sectors. ANVISA will provide the answer within 15 working days.

Ouvidoria / Ombuds Office 

The Ombuds Office is the proper channel to report a situation and/or express   complaints, suggestions, requests and compliments. An online form is available on their website and the answer can take up to 15 working days.

Audiências / Audience

A space called Parlatório is available for meetings between ANVISA and the community. Using the online form available on their website you can request a meeting with an specific area of ANVISA, informing the subject of the meeting. The request must be submitted at least 10 working days before the proposed meeting date. You also have the option of requesting an online Skype meeting.

Serviço de Informação ao Cidadão (SIC) / Citizen Information Service

Face-to-face service available at ANVISA’s headquarters, in Brasília, on weekdays from 8h to 18h, no previous appointment needed. Depending on the query, ANVISA might take up to 15 working days to provide the answer.

A Customer Satisfaction Survey is conducted by ANVISA every year in order to get feedback from citizens who attended the service and identify weak aspects and possible changes. The results are published on their website.

Contacting ANVISA in English and/or Spanish

There is an exclusive online form available on their website to receive queries in foreign languages – preferably Spanish or English.

INMETRO

Fale Conosco / Contact us

INMETRO provides five phone numbers in different Brazilian States: Rio de Janeiro, Rio Grande do Sul, Goiás and Brasília.

Perguntas Frequentes / FAQ

Available on their website list of frequently asked questions received through the Ombuds Office.

Ouvidoria / Ombuds Office

The Ombuds Office is the proper channel to report a situation and/or express   complaints, suggestions, requests and compliments. The Office operates online through a government platform called Fala.BR.

There is also a contact number (0800 285 1818) available Monday to Friday, from 9h to 17h.  Queries can also mailed or delivered to INMETRO’s office in Rio de Janeiro on weekdays from 8h to 17h.

Complaints can be sent by e-mail to saccgcre@inmetro.gov.br.

Carta de Serviços / Services Menu

INMETRO provides, for online consultation or download, a list of the services and activities performed by the Institute. Details concerning timeframes, reaching out to the Institute and standards defined by INMETRO are all presented in the document.

ANATEL

Internet

The online service channel is recommended to report a situation or express complaints, suggestions, requests and compliments. The access to the system, called FOCUS, requires previous user registration.

App

ANATEL Consumidor App can be used to report a situation and/or express complaints, suggestions, requests and compliments, through your phone or tablet. A FAQ section on the app can be checked for general queries. The app is available for Android, iOS and Windows Phone and can be downloaded on your App Store for free. The same username can be used for the App and online service.

Android: https://goo.gl/YMBdQS
iOS: https://goo.gl/d5RYtF
Windows Phone: http://goo.gl/SwMFEk

On-site Service

A space called Sala do Cidadão (citizen room) is available in each capital city in Brazil to provide customer service for those who choose not to use the app, online service or phone. Check the addresses and open hours on their website.

Call Center

ANATEL’s call center operates on weekdays from 8h to 20h, except from holidays.  The phone number 1331 is available for those who wish to report a situation and for general queries.

Perguntas Frequentes / FAQ

Available on their website list of frequently asked questions.

___________

Our team has the experience to work as link between you and all the Brazilian Regulatory Agencies and contacting the regulatory agencies is a key factor in sucessifully achieving the best results. In case you have any questions or comments, our team is more than willing to assist you.

Follow us on social media to get an update on the top news regarding the Brazilian regulatory system.

DOMO Salute Team

O post Contacting Brazilian Regulatory Agencies – ANVISA, INMETRO e ANATEL apareceu primeiro em Domo Salute.

Brazilian medical device market regulator ANVISA recently published the annual Management Report concerning 2018’s results. According to Willian Dib, ANVISA’s CEO, presenting the annual report to the society reaffirms the Agency’s commitment and transparency.

DOMO’s Team has evaluated the report and summarized the highlights and key results achieved by the agency regarding medical device:

Almost 16 new registrations per day

The management report highlights that 5.780 new medical device were approved in 2018, composed by 1.106 Registro (products classified as Risk Class III and IV) and 4.674 Cadastro (products classified as Risk Class I* e II). The amount of products being registered in 2018 corresponds to almost 16 new medical device per day. The numbers also represent new registrations increasing 11,4% in the past 3 years (2016 to 2018).

*Before May 2019, products classified as Risk Class I had to comply with the Cadastro route. Since then, a new path has been created, and Risk Class I products are now regularized by Notification. Learn more from our post about Notification. https://domosalute.com.br/blog-1/new-regularization-for-class-i-medical-devices-notification

Brazilian Good Manufacturing Practice Certification – 513 granted to foreign manufacturers

Manufacturers of Risk Class III and IV medical devices must be in compliance with the Brazilian Good Manufacturing Practice (BGMP). During 2018, 99 on-site audits were performed abroad in order to achieve the certification. Also, 513 BGMP certification were granted to foreign manufacturers (new certification and renewals), while 13 applications were rejected.

Technovigilance

Technovigilance is designed to ensure that approved medical devices function in accordance by early detecting problems related to use, and promoting measures to eliminate or minimize the risks. Adverse incidents must be reported in case of malfunction and inadequate labeling, for example.

ANVISA received 13.227 formal complaints through the system NOTIVISA. The majority (93,7%) were related to medical device, whilst 4,7% were related to medical equipment and 1,6% to IVD products.

The majority of adverse events reported to ANVISA were also related to medical device (73,7%), and 26,3% related to medical equipment.

Regulatory stock management 

Managing the regulatory stock means organizing the current rules, monitoring their effectiveness and generating inputs for their review. The main goal is making the stock more efficient, rational, clear and understandable. ANVISA has been working towards a more effective regulatory stock management since 2014, and has achieved significant results in 2018. Check our post about ANVISA’s Regulatory Guillotine to learn more.

Economic Studies and Regulatory Intelligence

Since May 2018 a health product pricing panel is available for consultation on ANVISA’s website. The pricing panel gathers information on more than 5,000 model-products. The data is available for consultation by business name, product model, registration number, among others.

In addition to the basic information, the price to be practiced in the domestic market and prices in other countries are also available. The information is consolidated in an interactive panel provided by ANVISA on their website.

Download 2018 Management Report (Portuguese only).

Check ANVISA’s Management Report summary folder 2018 (English).

Follow us on social media to get an update on the top news regarding the Brazilian regulatory system.

DOMO Salute Team

O post ANVISA’s special report: 2018 results apareceu primeiro em Domo Salute.

According to Leandro Rodrigues Pereira, General Manager of the GGTPS, the performance report is a management tool that attends to the Agency’s duty and commitment on being transparent and providing useful data to society and the industry. It also serves the purpose of monitoring the medical device sector’s services demands.

Check below DOMO Salute’s team analysis on the report and GGTPS’ more important results ion 2019:

Petition balance positive in 2019

The petition balance is calculated by taking into consideration the number of petitions completed (outcomes) and the number of petitions filed (incomes) at a set period of time. It is interesting to observe that the number of petitions waiting to be analyzed and/or under analysis, during the second trimester is lower comparing to the first trimester of 2019. The balance now is positive with 10.425 being the number of petitions entering GGTPS for analysis (incomes) and 11.823 the number of petitions completed (outcomes) in 2019.

The new regulatory path for lower risk products (Notification) is certainly one of the responsible for the better results achieved. Notification is a simple registration path for Class Risk I medical device, that came into effect on May 2019, and doesn’t require technical evaluation from the Agency. The measure has clearly impact positively on the balance.

Rejection rates are lowest since 2018

Rejection rates for the second trimester were 8,2%, the lowest since the beginning of 2018. Comparing to the first trimester of the year, the rejection rate is significantly lower, especially if we look at Registro submissions (Class risk III and IV) and secondary petitions.

ANVISA believes the good results are a reflection of a series of webinars that have been available at the Agency’s website as they might have helped companies to better understand the requirements, therefore reducing rejection rates.

Timeframe averages 

Regarding the timeframe to get ANVISA’s first response (being the approval issue or additional requirements) the average for the second trimester was 31.82 days – the lowest since the beginning of 2018. Certainly the good performance is also reflecting the advent of Notification path – which takes an average of 10 to 20 days to be issued by ANVISA.

Considering only the timeframe to get ANVISA to publish the approval (not their first response) – it rises up to 74.90 days. There’s been a small increase on the timeframe to issue Cadastro (Risk Class II) and Registro’s approval comparing to last year, but 2019 numbers are still satisfactory considering ANVISA’s performance throughout the years. The average is expected to decrease during the next semester due to Notification process reducing the workload and allowing ANVISA’s evaluators to focus on Cadastro and Registro petitions.

Taking a closer look on the different divisions’ performances (GEMAT – the division responsible for materials, GQUIP – division responsible for equipment and GEVIT – division responsible for IVDs) we can see that they share the same tendencies, which demonstrates they are working consistently and towards the same goals.

The performance report also presents a few highlights from the trimester such as:

• National and International Regulatory events with ANVISA’s participation;
• Important regulatory publications such as the Notification process and the public consultation on custom made devices.

To download the second trimester performance report for 2019, check ANVISA’s website.

Follow us on social media to get an update on the top news regarding the Brazilian regulatory system.

DOMO Salute Team

O post ANVISA’s performance report: An analysis on medical device and IVD registration apareceu primeiro em Domo Salute.

Field safety correction action information is now submitted to ANVISA by electronic system

Since the 22th of July manufacturers must submit field safety correction action information via ANVISA’s electronic system – called Solicita. Before that, the information was submitted to ANVISA by e-mail or hard copies.

Field safety correction actions are actions taken by manufacturers and medical devices’ registry holders to reduce the risk of adverse events and other incidents related to products marketed in Brazil.

By making all the information electronic ANVISA aims to organize the documentation received by the agency, give transparency to the actions taken and better manage the work flow.

QMI-SAI Canada new Notified Body recognized by ANVISA to perform MDSAP Audits

ANVISA recently (August 6) published the Resolution RE Nº 2.138, DE 5 DE AGOSTO DE 2019 granting QMI-SAI Canada Limited the status of notified body able to perform MDSAP on-site audits for medical devices’ manufacturers.

ANVISA is a member of the IMDRF and along with four other countries – Australia, Canada, Japan and the United States – compose the MDSAP participating regulators.

BGMP (Brazilian Good Manufacturing Practices) inspection requests for foreign manufacturers must be applied by a Brazilian Registration Holder, who will also be the holder of the certificate issued by ANVISA.

INMETRO is working on reducing the average time to issue Import Permits

INMETRO is working alongside with Global Alliance for Trade Facilitation and developing a project to reduce the deadline to issue Import Permits from 5 to 2 days by automating 70% of the requests. The results will start to show by the end of the year, informs INMETRO.

INMETRO gets through approximately 200 thousands of processes requesting Import Permits every year.  Low risk products’ Permits will be issued by an automatized, simple process which will allow INMETRO’s specialists to focus on high-risk products – improving the safety for importers and consumers. The risk level will be periodically reevaluated.

The action is a part of INMETRO’s effort to propose a new regulatory model aiming to create a less bureaucratic and more simple system.

INMETRO’s new Ordinance makes the approval of  measuring  instruments faster

INMETRO’s Ordinance 302/2019 published by the end of June has altered the procedures that must be taken in order to approve measuring instruments such as  blood pressure meters and clinical thermometers.

Before, the manufacturer or importer had to open a process with INMETRO, submit the instrument for INMETRO’s lab evaluation, wait for INMETRO´s reply, then send the instrument to an accredited lab and wait approximately 3 months for  the lab  to provide a test report to be evaluated by INMETRO. Waiting time could be up to 145 days.

Now, the company can submit the sample directly to the lab and the report, issued by the accredited lab, can be submitted directly to INMETRO thus making the process up to 3 months faster. The changes increase the process predictability and efficiency making it easier for the manufacturer to plan his entrance in the market.

INMETRO also published, on July 15th, the Ordinance 336/2019 concerning measuring instruments. Manufacturers and importers of certain measuring instruments can now obtain authorization to issue a declaration of conformity  instead of the initial verification that needs to be done to every instrument before they can be marketed in Brazil. Before the ordinance, the initial verification could only be carried by Brazilian Metrology and Industrial Quality Bodies.

Follow us on social media to get an update on the top news regarding the Brazilian regulatory system.

DOMO Salute Team

O post Brazilian Regulatory System – News Roundup apareceu primeiro em Domo Salute.

According to civil servant Raianne Liberal Coutinho, the agency realized that they weren’t providing easy access to the set of rules. The consequence was a large volume of conflicting, obsolete and unclear regulations.  In order to achieve a better control, the agency has created a cyclical management model that focuses on reviewing its normative acts. With this in mind, three initiatives have been set up.

The first one is the Themes Library, which is a way of providing society and the agency’s departments with access to all ANVISA’s rules, categorized into subjects. The system reduces the risk of creating conflicting rules, as the areas have easy access to all the regulations in force. The organized collection made it possible to easily identify the existence of obsolete normative acts.

“When the areas analyzed the library for validation, they identified rules that were no longer being used and that could be withdrawn entirely”, observes Coutinho.

Another mechanism created was The problem identification tool: an online form available on ANVISA’s website that anyone – inside or outside the agency – can access in order to easily report a problem with any specific rule. When the Agency identifies problems with a rule, it goes back into the regulatory agenda.

The third initiative is the so-called Regulatory Guillotine. “It is an unique mechanism to revoke a set of rules”, said Coutinho.  The first time ANVISA has taken actions to reduce the regulatory stock by eliminating obsolete regulations was in 2016. Since then, the Regulatory Guillotine has revoked 349 rules, which represents one-third of the existing regulation.

The last resulting action was RDC 292, published in June 26th , that withdrew 174 rules that were considered obsolete after public consultation.

“The Regulatory Guillotine is extremely important in the context of ANVISA’s amount of published rules. Since 1999 ANVISA publishes an average of 87 rules per year. From 2003, it has reached the amount of 126 rules per year, which means a new rule every two working days” – states ANVISA’s director Fernando Mendes.

By removing obsolete rules, the Agency is cleaning up the regulatory stock and making it easier to understand the normative set – that will now comprehend only the rules that are currently in effect.

Our team believes actions such as The Regulatory Guillotine are important to keep a simple coherent regulatory stock and they also demonstrate how actively the agency is working towards that goal. Talking specifically about medical devices, we had 12 revoked resolutions that were obsolete – they had been substituted in the past or set deadlines that were already expired.

Follow us on social media to get an update on the top news regarding the Brazilian regulatory system.

DOMO Salute Team

Check the list of rules that have been nominated for the Regulatory guillotine and the specific reason. (Portuguese)

Check RDC 292 and learn which rules have been recently revoked. (Portuguese)

O post ANVISA`s Regulatory guillotine apareceu primeiro em Domo Salute.

Also according to director Gustavo Kuster, manufacturers will have more responsibilities as well as freedom to market their products. “It takes us up to seven years to implement new measures nowadays. The solution is to rethink the entire model. Our strategy is to simplify, that’s why it is important that the community takes part in the public audiences that will be open aiming to narrow the existent proposals and to make the simplest regulation process possible. This is one of the new government’s goals.”

Making it less bureaucratic helps to increase competitiveness among products (either locally manufactured or imported) marketed in Brazil. It is vital to help companies by making INMETRO’s certification process faster – he adds.

“We need a simpler and less prescriptive regulation, that allows innovation” – highlights the director.
Currently, INMETRO works with a framework that covers 684 items, including a wide range of medical devices, which represents only 10% of the products marketed in Brazil. Kruse points out that we need to modernize our present regulation rules by creating basic general principles that will ensure the safety and quality of all products. The goal is to cover 100% of the products traded in the national market.

All citizens and companies will have 60 days to answer seven questions that will contribute to the first step into the changing process. In order to participate and make suggestions, please check INMETRO’s website.

INMETRO is concerned about making the future transition to the new model as smooth as possible for manufacturers, certification bodies and the society. In due course, changes regarding all the regulated products and categories will be scheduled considering the proper time for everyone to adjust. We believe the current public consultation indicates INMETRO’s intentions of building this project with the participation of the parties involved.

DOMO Salute’s team will take active part in the process and keep you informed on the following projects and changes regarding INMETRO’s certification.
Follow us on LinkedIn to get an update on the top news regarding the Brazilian regulatory system.

DOMO Salute Team

Check INMETRO’s proposal (Portuguese)
Watch Gustavo Kuster’s invitation to take part on the public consultation (Portuguese)
Access to the public consultation (Portuguese)

O post BRAZIL’s INMETRO proposing new model apareceu primeiro em Domo Salute.

In its 26th edition, the fair provided business opportunities, as well as new contacts, relationship strengthening, visibility, brand positioning support, and hosted several lectures and events promoted by major organizations and companies of the sector. Among the events that take place concurrently with the fair, the 10th Industrial Political Action and Medical Devices Regulation Day stands out. It is promoted by ABIMO and traditionally features numerous lectures presented by representatives of ANVISA and other regulatory bodies, among them INMETRO. Domo Salute’s regulatory specialist team was present at the event and kept a watchful eye on the new updates in the area.

Part of the event’s agenda included Sebrae Panel: Health in Brazil – Trends and Opportunities, which Domo Salute was privileged to be part of. On this occasion, Domo Salute gave lectures on three days, addressing the following subjects: “The Main Regulatory Challenges for European Medical Devices Registration” and “Current Issues Regarding Medical Devices Registration before ANVISA”.
Domo Salute’s regulatory manager and also a lecturer during the event, Amanda Frasson, observes, “Hospitalar is already a big event our company’s calendar and, as in previous years, its results have been very significant. Partnership strengthening, new business prospecting and further consolidation of our brand name in the market are some of the benefits Hospitalar provides us. Moreover, having the opportunity to speak in the biggest fair of the sector in Latin America has undoubtedly been a great achievement for our company.”

Diego Louzada, business developer in the company, also highlights the importance of the fair: “We are pleased and thrilled to have once again been part of Hospitalar, a mandatory event in Domo Salute’s calendar. This year we had the opportunity to speak during the fair for the first time, and we kicked off with three lectures. Meeting our customers and partners, being alert to innovations in our market, as well as prospecting new possibilities sort of outline our day-to-day in the fair. Our participation was very substantial and we already look forward to Hospitalar 2020, an event which will be held at a new venue.

O post Domo Salute at the 26th edition of Hospitalar Trade Fair apareceu primeiro em Domo Salute.

Regarding the medical devices market, there are INMETRO ordinances which require certification for several different types of products, although it doesn’t apply to all types of medical devices. The ordinance determines the certification system, procedures and requirements such as:
· factory audit;
· testing (applicable standards);
· documentation needed;
· applicant audit (Brazilian Company);
· certification maintenance.

Products INMETRO Ordinance
Equipment under Sanitary Surveillance 54/2016
Hypodermic and Gingival Needles 501/2011
Sterile Hypodermic Syringes for Single Use 503/2011
Single Transfusion, Gravitational Infusion and 502/2011
Infusion equipment for use with Infusion Pump.
Surgical Gloves and Gloves for Non-Surgical 332/2012
Procedures under Sanitary Surveillance
Male Natural Rubber Latex Condoms 50/2002
Breast Implants 162/2012
The certification is performed by the accredited certification bodies.
The INMETRO certificate, issued by the certification body, is one of the documents that must be delivered over to ANVISA when requesting the registration of the medical devices listed above.
The certification requires time and energy from the regulatory specialists; choosing the right certification body to conduct the process is one of the first but most important steps.
If you decide to enter the Brazilian market and reckon INMETRO is one of the steps needed for the registration, our experts will be pleased to clarify any registration requirements and guide you through the process, avoiding surprises that might affect the product launching schedule.

O post What about INMETRO apareceu primeiro em Domo Salute.

SAHE, which took place from March 12th to March 14th, held more than twenty forums, gathering over 400 speakers throughout the three-day schedule, thus offering around 400 hours of content to the visitors.

In terms of public, the fair joined all health chain links – including public authorities; hospital, clinic and laboratory executives; researchers; service and industry managers – from all Brazilian states, as well as other South American countries.

The Swiss Business Hub’s event, which DOMO Salute had been invited to participate, the main changes for the Swiss Hub Brazil were presented, including perspectives for 2019. In addition, the event featured an excellent talk by Tony Volpon, Chief Economist at UBS Brasil, which addressed the main economic challenges of the country for the coming months.

O post How were SAHE (South America Health Exhibition) and Expert Directory Event 2019 apareceu primeiro em Domo Salute.

To date, the regularization of Class I medical devices has taken place through the cadastro process. Under the new Resolution, the lowest risk products will be regularized through notification – a simplified system in which there will be no prior technical analysis of the petitions. The publication of the notification is expected within 30 days following the notification’s application and the payment of the ANVISA fee; that’s regardless of any documentary analysis by ANVISA. Only after the granting of the notification number can the product be industrialized or commercialized.

Here are some important topics featured in RDC 270/2019:
– The documentation required for the initial request and alteration of Class I medical devices remains the same, only with the change from the cadastro form to the notification form.

– The labels and instructions for use of notified products must comply with the requirements established in RDC 185/2001.- The notified products are exempt from revalidation.

– ANVISA may cancel product notification in such cases when it is proven that the product or the manufacturing process poses a risk to the health of the consumer, the patient, the operator or third parties involved; it’s also the case when information is deemed insufficient or there is an error in the sanitary framework of the notified products.

– The Technical Product Dossier remains mandatory for notified products.
– The notifications, their alterations and other actions will be published exclusively in the ANVISA website, in the section of consultation to regularized products.

– There will be no prior technical analysis of the notification requests; however, ANVISA reserves the right to make documentary evaluations of the notification processes at any time.

– The new legislation applies to the processes awaiting the first manifestation upon its entry into force.
– Class I devices already registered in ANVISA will have their cadastrosautomatically converted into notifications, maintaining the same registration number.

O post Class I Medical Devices Notification apareceu primeiro em Domo Salute.

More detailed information about the fair: https://www.arabhealthonline.com/en/Home.html

O post Arab Health 2019 in Dubai and DOMO Salute will be there apareceu primeiro em Domo Salute.

Jair Bolsonaro, Brazil’s new president, began his four-year mandate on January 1st. One of the attributions of the new Brazilian leader is the structuring of his team and his ministers are the most important people in this group.

The new Health Minister, Luiz Henrique Mandeta, is a doctor from Campo Grande city, Mato Grosso do Sul state (MT). He was invested in this position on January 2nd. In his inaugural speech he said, “We will write together a new page in public health” and pointed out his priorities: health promotion and disease prevention with the strengthening of Primary Care, strengthening of vaccination rates and computerization of the whole Health network, among others.

About sanitary surveillance and consequently ANVISA’s role, the minister mentioned: “We will reorganize sanitary surveillance so that we will have a more organized, attentive and fast system. Surveillance will do surveillance, and do it well”.

DOMO Salute wishes that the new minister exert his mandate with competency and responsibility, while we will continue performing our mission in the sanitary surveillance field: enabling the access of the new medical technologies to the Brazilian population and strictly enforcing what is predicted in the Brazilian legislation.

Know more about his professional career:

Luiz Hernique Mandetta is a doctor and he has a degree in Orthopedics, with specialization on Pediatrics Orthopedics (Atlanta, Georgia – USA). He has studied Health System and Service Management at FGV, Brazil.

In the beginning of his career, he he was a doctor at HGE and in the 1990s worked at SCCGH and the University Hospital. He taught post-graduate courses at the FUMS. In the early 2000s, he was technical counselor at Santa Casa Hospital, president at Unimed and counselor at Regional Medicine Council of Mato Grosso do Sul.

In the public sector, he was City Health Secretary of Campo Grande city between 2005 and 2010. After this time, he has elected as a congressman by Mato Grosso do Sul State for two mandates (2011 to 2018), where his effort was concentrated on social assistance, mainly in health, medicine, social assists and education, besides being the representative of the of the Brazilian Congress in Mercosur Parlament.

Diego Louzada – Co-founder and Business Developer of Domo Salute

Fonts:

http://portalms.saude.gov.br/o-ministro

http://portalms.saude.gov.br/noticias/agencia-saude/45054-luiz-henrique-mandetta-assume-ministerio-da-saude

http://www.planalto.gov.br/ccivil_03/leis/L9782.htm

O post Brazil has a new Minister of Health: Luiz Henrique Mandetta apareceu primeiro em Domo Salute.

A survey conducted by Media Group noted that 55% of respondents believe that the current government will be good for the sector and also indicated a perspective of growth of the health sector for this year.

The talk, made by Mauro Junqueira, President of Conasems, addressed the dimensions and challenges of the Unified Health System (SUS). Mauro Junqueira defended the SUS despite understanding that there is a great opportunity for improvement in the execution of the services provided by the SUS.

The second lecture, given by Ricardo Valentim, from Lais – Laboratory of Technological Innovation in Health, covered Humanitarian Health and showed an analysis on primary care. Ricardo Valentim defends the idea of ​​developing an anti-disciplinary leadership model, which is not hierarchical yet horizontal and focused on solving problems, which makes the system more resilient and responsive. He said, “A well-solved problem in Brazil may have a scale of world-wide resolution.”

After the two talks, the roundtable discussions began. “Building the future of health: the role of the protagonists of the sector in face of the new times of Brazilian politics” was the subject of the first round table of Welcome Saúde 2019(link).

The second table included New horizons: The influence of the economy in the construction of a more efficient health. The debates brought together representatives of the main links in the health chain with the presence of Mauro Junqueira, from Consems; Ricardo Valentim, Lais; Ruy Baumer, Comsaúde, Rodrigo Lopes, the Lefort Group; Alceu Alves da Silva, VP of MV; Luiz Aramicy Pinto, FBH; Claudia Cohn, Abramed; Paulo Fraccaro, Abimo; Giovanni Guido Cerri, the Radiology Institute of HCFMUSP; Marcos Marques, Abradimex; Francisco Balestrin, IHF; and Franco Pallamolla, Abimo.

We believe that initiatives and events such as Welcome Saúde 2019 promote more discussions and contribute to the development of health in the country. Entities, companies and people should take a close look at the economic and political aspects of that and contribute to the resolution of problems along with the competent bodies (such as ANVISA, for example) so that the country can well assist that which is the main focus of all discussions: the Brazilian patient.

O post Welcome Saúde 2019- the event that presented the political and economic perspectives for the health apareceu primeiro em Domo Salute.

According to the Agency, of February 25, the subject codes of secondary petitions (changes, revalidations, additions, cancellations, rectifications, among others) will also be available for electronic petition and protocol.
Click here to access
Font: Anvisa Website:  http://portal.anvisa.gov.br

O post Medical devices now enjoy the use of electronic petition apareceu primeiro em Domo Salute.

Medical devices that may be processed are those that allow repeated cleaning, disinfection or sterilization and that can be reused, given they comply with current regulations. This reprocessing should not be repeated indefinitely: there is a moment at which the quality of the product – in terms of its effectiveness and functionality – no longer corresponds to that required for its use.

For this reason, ANVISA opened Public Consultation 584, on December 20th, 2018, which was published in the Official Gazette on December 21st, 2018, in order to receive comments and suggestions from the general public regarding the text of the proposed resolution which deals with the categorizing of medical devices as single use or reusable. The Public Consultation will be open for 60 days, from January 8th to March 9th, 2019. Suggestions should be sent by electronic form in Portuguese.

Exceptionally, international contributions may be sent through letter to the following address: National Health Surveillance Agency (Ainte) – SIA, Section 5, Special Area 57, Brasília-DF, CEP 71.205-050.

In addition to this specific CP, another one has been open with two other connected themes: The first one (CP 585) is related to the requirements of good practices for the processing of products used in health care assistance. Anvisa’s goal with the proposal of a new RDC is to improve the management of risks associated with the processing of medical devices.

The second one (CP 586) deals with a Normative Instruction (IN) that establishes guidelines for quality assurance in health services and its main purpose is validation, monitoring and controlling the routine of sterilization processes and automated cleaning processes as well as disinfection in its services.

To contribute your opinion go to:
CP 585.
CP 586.

Font: Anvisa Website: http://portal.anvisa.gov.br

O post PUBLIC CONSULTATION ANVISA – single use and reusable medical devices apareceu primeiro em Domo Salute.

It will be a pleasure to meet you there if you will attend the fair as well.
To schedule a meeting, please contact us: domosalute@domosalute.com.br
More detailed information about the fair: https://www.medica-tradefair.com/

O post Medica Fair apareceu primeiro em Domo Salute.

According to the new legislation, the registries of medical devices and IVDs (risk classes III and IV) will have a validity extended of five to ten years, beginning from the day of its publication in Brazilian Official Gazette (DOU). The registrations may be renewed successively for the same period. It is important to note that the validity of current registries (approved prior to the publication of the new Resolution) will be automatically extended to ten years. The requests for registry renewal which were applied to ANVISA up to the date of publication of the new Resolution shall be closed by ANVISA.
According to ANVISA, the new RDC reflects the advance of the regulatory model for medical devices, which allows the extension of the validity period of the registries without compromising the health risk control, since all activities of inspection and monitoring of these products will be preserved inside the National market.

From the point of view of DOMO Salute, the new legislation brings benefits to manufacturers and importers, once the maintenance of the registries of medical devices becomes easier and less costly and consequently, makes Brazil more attractive for the entrance of these products.

O post ANVISA Extends the Validity of Medical Device Registry to Ten Years apareceu primeiro em Domo Salute.

O post ANVISA publishes RDC n °183-2017 that changes procedures for concession of Certificate of Good Manufacturing apareceu primeiro em Domo Salute.