Brazilian Regulatory Agencies & Covid-19

In response to the COVID-19 outbreak, Brazilian regulatory agencies (ANVISA & INMETRO), as well as many other regulators around the world, have released in the past month Ordinances and Resolutions regarding emergency and temporary procedures for medical devices that are strategic to fight against the pandemic.

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