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

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 Manufacturing Practices (BGMP)? - How does RDC 665/2022 align with global standards like ISO 13485 and FDA QSR? - Can an MDSAP audit be used to achieve BGMP certification in Brazil? - What are the key dates associated with the implementation of RDC 665/2022? - Why is BGMP compliance a mandatory step for selling medical devices in Brazil? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, leveraging local expertise and advanced AI to streamline global market access. We act as your local representative in over 30 markets, developing efficient regulatory strategies and using AI to compile and submit technical dossiers. Our integrated approach allows a single registration process to access multiple markets, supported by our global reach and technology-driven efficiency. Whether you are a startup or a multinational, we provide scalable solutions to get your innovations to market faster. Contact us at [email protected], visit https://pureglobal.com/, or explore our FREE AI tools and database at https://pureglobal.ai/.