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?

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