ANVISA’s upcoming regulation on SaMD’s – Software as Medical Device –

ANVISA published in January the SaMD Regulatory Impact Analysis Report regarding important information for the safe and effective use of medical softwares as well as the sanitary actions associated with these products . According to the Agency, traditional regulations for medical devices have a gap, as they do not cover specific aspects for this type of product.

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.

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DOMO Salute Team