This episode of LATAM MedTech Insights unpacks the significant changes introduced by Brazil's new medical device regulation, ANVISA RDC 751/2022. We explore how this new framework moves Brazil towards harmonization with international standards, particularly the EU MDR, and what this means for global MedTech companies. We break down the practical impact of the updated risk classification system and the new technical dossier structure. This shift is a game-changer for manufacturers, promising to reduce complexity, time, and cost when entering Latin America's largest market. **Case Study:** Imagine a US-based MedTech scale-up with an innovative patient monitoring system that has already achieved CE marking in Europe. They view Brazil as a critical growth market but are hesitant due to its reputation for complex, unique regulatory requirements. Their primary pain point is the fear of investing months of work and significant capital to completely re-author their technical documentation just for one market. RDC 751 directly solves this by allowing them to leverage their existing EU MDR-compliant dossier, turning a potential roadblock into a streamlined entry point. **Key Takeaways From This Episode:** * How does the new four-tier risk classification system under RDC 751 affect your market entry strategy for Brazil? * What specific sections of your existing EU MDR or FDA technical file can now be repurposed for an ANVISA submission? * Are there changes to the requirements for Brazilian Good Manufacturing Practice (B-GMP) certification? * How does the new regulation impact the need for and the role of a local Brazil Registration Holder? * What are the updated pathways for low-risk versus high-risk devices, and how do they affect your launch timeline? * How will ANVISA's alignment with the IMDRF framework change your future global registration planning? * What are the key considerations for post-market surveillance under the new RDC 751? At Pure Global, we specialize in turning regulatory complexity into market opportunity. With our local expertise in Brazil and advanced AI tools, we offer end-to-end solutions to streamline your ANVISA registration process under RDC 751. Let us be your partner in unlocking the potential of the LATAM market. Contact us at [email protected] or visit https://pureglobal.com/ to learn more.