Latest / Medical Device Global Market Access
DePuy Synthes in Brazil: Navigating ANVISA's RDC 751/2022 for Orthopedic Devices
This episode examines the Brazilian market for orthopedic medical devices, using DePuy Synthes (a J&J MedTech company) as a case study. We break down the essential regulatory requirements set by ANVISA, including the pivotal RDC 751/2022 resolution, device classification, the mandatory Brazilian Registration Holder (BRH), and Good Manufacturing Practice (B-GMP) certification. Learn how a global leader successfully navigates one of Latin America's most challenging yet rewarding markets. Key Questions: - What is ANVISA's role in regulating orthopedic devices in Brazil? - How does the RDC…
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