Latest / Medical Device Global Market Access
Unlocking the Brazilian MedTech Market: ANVISA's Reliance Route & High-Risk Cardiology Devices
This episode explores the lucrative but complex medical device market in Brazil, the largest in Latin America. Using Abbott's Cardiac Rhythm Management (CRM) division as a practical example, we break down the critical regulatory requirements for high-risk devices. We cover the role of the national authority, ANVISA, the essential RDC 751/2022 regulation, the mandatory Brazilian Registration Holder (BRH) system, and the stringent Brazilian Good Manufacturing Practice (B-GMP) certification. We also discuss the game-changing new 'Reliance' pathway introduced in June 2024, which allows leveraging…
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