Latest / Medical Device Global Market Access
Brazil's Regulatory Gatekeeper: Navigating the Brazil Registration Holder Requirement
This episode provides a comprehensive guide to the Brazil Registration Holder (BRH), a mandatory requirement for foreign medical device manufacturers seeking market access in Brazil. We explore the critical role the BRH plays as the legal holder of the ANVISA registration, detailing their extensive responsibilities from initial submission to post-market surveillance. The discussion emphasizes the strategic importance of choosing between a distributor and an independent third-party representative, highlighting the risks of commercial lock-in versus the flexibility and control offered by an…
The skinny
The skinny isn't ready yet — notes appear once the transcript is processed.