This week, we dissect the latest critical guidance from Brazil's ANVISA on RDC 751, a regulation that aligns the country's medical device framework with the EU's MDR. This is more than a policy update. it's a strategic shift that redefines the requirements for market access in Latin America's powerhouse. We explore the immediate impact on technical dossiers, post-market surveillance, and the newly empowered role of the Brazil Registration Holder.

This episode is for any MedTech manufacturer eyeing the Brazilian market. We break down the hidden complexities and strategic opportunities this presents. Imagine a global scale-up, already EU MDR approved, that believed its entry into Brazil would be seamless. They are now facing unexpected delays and costly rework because their technical file missed nuanced local requirements hidden within the new guidance. Their entire product launch is at risk.

Key questions from this episode include:

- Is your current technical file truly ready for ANVISA's new dossier structure?

- How does the new risk classification system impact your device registration timeline?

- What are the unwritten rules for post-market surveillance that ANVISA now expects?

- Could your existing EU MDR strategy create unforeseen compliance gaps in Brazil?

- Are you prepared for the expanded liability now placed on your Brazil Registration Holder?

- What specific labeling and instruction-for-use changes are required immediately?

- How can you leverage local representation to accelerate the new review process?

Pure Global offers end-to-end regulatory consulting solutions for Medical Technology (MedTech) and In-Vitro Diagnostic (IVD) companies, combining local expertise with advanced AI and data tools to streamline global market access. Contact Pure Global at [email protected] or visit us at https://pureglobal.com/.