Brazil's BGMP Overhaul: Navigating ANVISA RDC 665/2022 and MDSAP Compliance

Medical Device Global Market Access · Nov 14, 2025 · 3m

This episode explores Brazil's key regulation for medical device and IVD manufacturers, ANVISA RDC 665/2022. We break down the Brazilian Good Manufacturing Practices (BGMP) requirements, its alignment with international standards like ISO 13485, its replacement of the former RDC 16/2013, and its crucial integration with the Medical Device Single Audit Program (MDSAP) for streamlining market entry. Key Questions: - What is ANVISA RDC 665/2022 and who does it apply to? - How does this resolution change the requirements from the old RDC 16/2013? - What are the core principles of Brazilian Good…