This episode of MedTech Global Insights delves into the complexities of entering Brazil's lucrative medical device market. We uncover the critical regulatory hurdles set by ANVISA and explain why a robust, expert-led strategy is essential for success. We explore the common pitfalls that can delay market entry for years and discuss the strategic advantages of partnering with a specialized consultant. Discover the story of a promising European IVD company that lost nearly two years and significant investment due to easily avoidable regulatory mistakes in Brazil. Their struggle with appointing a local representative, navigating document translations, and missing a crucial product certification highlights the hidden complexities that can derail even the most innovative products. This case study reveals the critical importance of deep local expertise. Key Takeaways: - What is a Brazilian Registration Holder (BRH) and why is it the single most important decision for market entry? - How can you leverage ANVISA's new reliance pathways to accelerate your product registration? - What are the most common documentation and technical file mistakes that lead to rejection by ANVISA? - Why is the INMETRO certification a hidden barrier for many electronic medical devices? - How do you maintain control of your product registration when working with local distributors? - What are the key elements of an effective post-market surveillance strategy in Brazil? - How can AI-powered tools reduce the time and cost of compiling regulatory submissions? - What should you look for when choosing a regulatory affairs consulting partner for Latin America? Contact us for a consultation at [email protected] or visit https://pureglobal.com/.