Latest / Medical Device Global Market Access
Korean MedTech in Brazil: Navigating ANVISA's B-GMP Certification
This episode unpacks the most critical step for Korean medical device companies entering the Brazilian market: ANVISA's Brazilian GMP (B-GMP) certification. We detail the mandatory B-GMP requirements for Class III and IV devices and compare the two main compliance pathways. Discover the significant time and cost advantages of leveraging MDSAP certification, which can extend certificate validity to four years and potentially waive on-site inspections, versus the timeline and costs associated with a direct ANVISA audit at your Korean facility. We also explain how to use your existing K-GMP…
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