This episode provides a detailed analysis of Brazil's RDC 687/2022, a critical regulation from ANVISA governing Good Manufacturing Practices (GMP) certification for Class III and IV medical device manufacturers. We explore the key requirements, audit procedures, and documentation needed to secure the mandatory CBPF certificate, highlighting the changes from the previous RDC 183/2017 and what international manufacturers must do to successfully enter the Brazilian market for high-risk devices.

Key Questions:

- What is ANVISA's RDC 687/2022 and who does it apply to?

- How does this regulation impact manufacturers of Class III and IV medical devices?

- What are the mandatory steps to obtain GMP certification in Brazil?

- What replaced the previous RDC 183/2017 regulation, and when?

- How long is the Brazilian GMP certificate valid for?

- What kind of documentation is required for the submission to ANVISA?

- Why is this certification a prerequisite for market entry in Brazil?

Navigating regulations like Brazil's RDC 687/2022 is where Pure Global excels. We offer end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access with local expertise and AI tools. Our team acts as your local representative in Brazil and over 30 other markets, developing efficient pathways for ANVISA approval and using AI to compile technical dossiers. We manage submissions and ensure ongoing compliance so you can access markets faster. For comprehensive support, contact us at [email protected], visit https://pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.