Brazil's New MedTech Rules: Pure Global on Cracking the RDC 751 Code

Brazil's MedTech market just experienced a seismic shift. ANVISA, the national regulatory agency, has rolled out its new comprehensive framework, RDC 751, fundamentally changing the rules for medical device registration and market access. This move aligns Brazil closer than ever with international standards like the EU MDR. In this episode, we break down what this massive overhaul means for manufacturers. We dissect the new risk classification system, the updated submission pathways, and the critical changes to technical dossier requirements, providing a clear roadmap for anyone looking to enter or stay in Latin America's largest healthcare market. Imagine a MedTech scale-up from the United States with an innovative orthopedic implant. They viewed Brazil as a primary expansion target but were stuck. Their main pain point was the regulatory divergence. Their FDA and EU technical files required a complete, costly, and time-consuming overhaul for the old Brazilian system, creating a barrier of over 18 months of work before they could even submit. With the new RDC 751, the question now is: can their existing EU MDR dossier fast-track their entry, or are there hidden complexities in the new rules that could still derail their launch? Key Takeaways: * How do the new four risk classes under RDC 751 compare to the previous Brazilian system? * What specific documents from my EU MDR technical file can be repurposed for a Brazilian submission? * Is the simplified `notificação` pathway truly faster for Class I and II devices? * What are the new labeling and IFU requirements that manufacturers often overlook? * How has the definition of a "medical device family" changed for submissions? * What are the new obligations for the Brazil Registration Holder (BRH) under RDC 751? * Are there any new post-market surveillance requirements that come with this framework? At Pure Global, we specialize in demystifying complex regulatory changes like Brazil's RDC 751. We offer end-to-end solutions, from developing a tailored regulatory strategy to compiling your technical dossier and acting as your local Brazil Registration Holder. Our unique blend of local expertise and advanced AI tools streamlines your path to market access in over 30 countries. Don't let regulatory hurdles block your growth in LATAM. Contact us today at [email protected] or visit https://pureglobal.com/ to learn how we can accelerate your success.