Unlocking the Brazilian MedTech Market: ANVISA's Reliance Route & High-Risk Cardiology Devices
Medical Device Global Market Access · Pure Global
December 15, 20253m 13s
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Show Notes
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 approvals from agencies like the US FDA to expedite market entry.
- What makes Brazil such an attractive market for MedTech companies?
- Who is ANVISA and what is their role in medical device approval?
- What are the key requirements under the RDC 751/2022 regulation?
- Why is a Brazilian Registration Holder (BRH) essential for foreign manufacturers?
- What is involved in obtaining a Brazilian GMP (B-GMP) certificate for a Class III or IV device?
- How does ANVISA's new 'Reliance' route, effective June 2024, change the game for market access?
- What lessons can be learned from Abbott's strategy for distributing pacemakers and ICDs in Brazil?
- What are the specific language requirements for labeling in Brazil?
Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access. We act as your local representative in over 30 markets, including Brazil, developing efficient regulatory strategies and using advanced AI to compile technical dossiers. Our experts navigate complex requirements like ANVISA's RDC 751/2022 and B-GMP certification, while our new AI tools help you monitor regulatory changes. Whether you're a startup or a multinational, we accelerate your path to market. Contact Pure Global at [email protected], visit https://pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.