ANVISA Technovigilance Changes in Brazil: What to Expect After the Public Consultation

Medical Device Global Market Access · Jul 21, 2026 · 4m

This episode covers the recent closure of Brazil ANVISA's public consultation (Call for Contributions No. 4/2026) on a new technovigilance framework. We discuss the implications for medical device manufacturers, the expected changes to adverse event reporting and post-market surveillance, and practical steps to prepare for the upcoming regulations in Brazil. Key Questions: - What does the closing of ANVISA's public consultation on technovigilance mean for the industry? - How will the new framework likely change adverse event reporting in Brazil? - Who is responsible for complying with the…