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 independent partner. Key Questions • What is a Brazil Registration Holder (BRH) and why is it mandatory for ANVISA approval? • What are the legal responsibilities that a BRH assumes for a medical device? • What are the significant risks of appointing a distributor as your BRH? • How does an independent BRH give you more control over your Brazilian commercial strategy? • What key duties does the BRH perform, including B-GMP certification and vigilance reporting? • Which recent ANVISA regulations, like RDC 751/2022, define the current requirements? • Why is transferring a device registration to a new holder often a complex process? • How does the BRH model protect a manufacturer's intellectual property? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.