Brazil – ANVISA suspends expedited registrations for COVID-19 products

During a recent meeting of the Collegiate Board of Directors of Brazil’s National Health Surveillance Agency (ANVISA), Emergo by UL representatives learned that ANVISA will likely decline to extend the validity period for Resolutions RDC No. 348/2020 and 349/2020 (links in Portuguese). These Resolutions had temporarily established an expedited registration scheme for IVDs, personal protective equipment (PPE), and certain medical devices used for the prevention or treatment of COVID-19.

Regulations for expedited COVID-19 registration are deemed to have served their purpose

According to the directors who spoke in the meeting, the extension of these Regulations is unnecessary because Brazil already has an adequate supply of medical devices, IVDs, and PPE to treat and diagnose COVID-19 patients. Although ANVISA has yet to issue an official statement on the matter, submissions for expedited registrations are currently no longer being accepted…