Brazil represents a massive opportunity for MedTech companies, but its complex regulatory body, ANVISA, can be a significant barrier to entry. This episode of MedTech Global Insights demystifies the process of obtaining a medical device import license in Brazil and reveals what to look for in a world-class regulatory consultant. We explore the critical decision of appointing a Brazilian Registration Holder (BRH), the strategic pitfalls of using a distributor for this role, and the deep impact of recent regulations like RDC 751/2022. Discover how an integrated approach combining local, on-the-ground expertise with advanced AI technology can transform your market access strategy from a source of frustration into a competitive advantage. For instance, consider a European IVD startup with a groundbreaking diagnostic tool. They were poised for the Brazilian market but found themselves entangled in a nightmare. Their chosen local partner, who also served as their distributor, held the import license, effectively controlling their market access. When commercial disagreements arose, the distributor refused to transfer the license, halting all sales and forcing the startup into a costly legal battle to regain control of their own product. This episode delves into how to avoid this common and devastating scenario. What You'll Learn: 1. Why is appointing the right Brazilian Registration Holder (BRH) the single most critical decision for market entry? 2. What are the hidden risks of letting your distributor control your product registration? 3. How does the new RDC 751/2022 regulation change the game for ANVISA submissions? 4. How can you leverage your existing approvals, like CE or FDA, for a faster review in Brazil? 5. What are the most common and costly mistakes foreign companies make in their technical dossiers? 6. Why is a combination of local expertise and AI-powered data tools essential for success with ANVISA? 7. How can an independent consultant help you build a scalable regulatory strategy for all of Latin America, not just Brazil? 8. What key questions must you ask a potential consultant before trusting them with your market access? Contact us at [email protected] or visit https://pureglobal.com/ for more.