This episode delves into a crucial aspect of the Brazilian medical device market: the role of the Brazil Registration Holder (BRH). We explore the significant differences and long-term consequences of appointing a distributor versus an independent third party to hold your device registration with ANVISA. Learn how to avoid common pitfalls that can limit your commercial flexibility and gain control over your market strategy. • What is a Brazil Registration Holder (BRH) and why is it mandatory? • What are the hidden risks of appointing your distributor as your BRH? • How does using a distributor as a BRH limit your ability to change sales partners? • Why is an independent BRH a more strategic choice for market entry? • What are the benefits of separating regulatory holding from commercial distribution? • What does Brazilian Resolution RDC 102/2016 say about transferring a registration? • How can you protect your intellectual property when registering a device in Brazil? • What is the best strategy to ensure long-term control and flexibility in the Brazilian market? 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.