Brazil's MedTech market is the largest in Latin America, offering significant growth opportunities for medical device and IVD manufacturers. However, gaining market access is a formidable challenge due to the complex and stringent regulations enforced by the National Health Surveillance Agency, ANVISA. This regulatory barrier can lead to costly delays and commercial dead-ends for companies that are unprepared. In this episode of MedTech Global Insights, we break down the specific hurdles foreign companies face when entering Brazil. We explore the critical importance of the Brazil Registration Holder (BRH) role, the common strategic errors in appointing a distributor for this function, and the detailed requirements of the new RDC 751/2022 regulation. Learn how to turn these challenges into a competitive advantage with the right local expertise and strategy. **Case in Point:** Imagine spending over a year preparing your product submission for Brazil, only to have ANVISA reject it due to a subtle documentation error. This is a common reality for firms who underestimate the nuances of local regulations, forcing them into another cycle of costly delays while competitors establish their footprint. Discover how an independent, expert-led strategy can prevent this and secure your path to market. **In this episode, you will learn:** - Why is appointing an independent Brazil Registration Holder (BRH) a critical first step for market entry? - How does the new RDC 751/2022 regulation impact your existing technical documentation? - What are the most common pitfalls foreign companies face when submitting their dossiers to ANVISA? - How can you leverage your existing EU or US regulatory approvals to streamline your entry into Brazil? - What are the key differences between using a distributor as your holder versus an independent representative? - How can technology and AI accelerate the submission process for the Brazilian market? - What are the ongoing post-market surveillance requirements you cannot afford to ignore? To learn more about navigating the Brazilian market and other global regulatory challenges, contact us at [email protected] or visit https://pureglobal.com/.