Latest / Medical Device Global Market Access
Brazil GMP Certification: A Deep Dive into RDC 687/2022 for Class III/IV Devices
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…
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