In this episode of MedTech Global Insights, we explore the immense opportunities and critical challenges of entering Brazil's medical device market. We unpack the complex regulatory landscape governed by ANVISA and reveal the number one mistake foreign manufacturers make when seeking approval. Discover why your choice of a local partner can either lock your product's potential or unlock market-wide success. We share a common but costly scenario where a successful device manufacturer loses control of its own product registration, effectively getting held hostage by its in-country distributor. This episode provides a strategic blueprint for navigating these challenges, ensuring you retain control and flexibility in Latin America's largest market. **In This Episode, You'll Learn:** - What is a Brazil Registration Holder (BRH) and why is it the most critical decision for market entry? - How can appointing your distributor as your BRH put your entire Brazilian business at risk? - What are the key requirements of ANVISA's new RDC 751/2022 resolution? - How does the Medical Device Single Audit Program (MDSAP) impact your registration strategy in Brazil? - Why is an independent regulatory partner essential for long-term success and compliance? - How can you leverage your existing technical documentation to accelerate entry into Brazil? - What upcoming changes, like the UDI system, should you be preparing for now? Contact us to learn more about our end-to-end regulatory solutions. Email us at [email protected] or visit https://pureglobal.com/