Brazil's ANVISA AI Gambit: Pure Global on Hacking the MedTech Approval Backlog.

Last week, Brazil's regulatory agency, ANVISA, unveiled a groundbreaking 2025 plan to tackle its notorious medical device approval backlogs. The initiative, named "AnvisAI," leverages artificial intelligence to create an automated fast-track system for lower-risk devices, aiming to cut review times by more than half and reshape the market access landscape. This move signals a major shift, potentially transforming Brazil from one of the most challenging LATAM markets into a hub for MedTech innovation. This episode unpacks the details of the AnvisAI project, exploring what it means for manufacturers' regulatory strategies and the immediate opportunities it creates for faster market entry. We explore a critical case study: Imagine launching an innovative Software as a Medical Device (SaMD) and facing a 24-month approval delay, tying up capital and stalling growth. ANVISA's new AI-driven pathway could slash that wait time to just a few months, completely changing the financial and strategic calculus for entering Brazil. Key Takeaways: 1. What exactly is the "AnvisAI" project and how will it re-classify devices for the new fast-track? 2. Which specific device classes stand to benefit the most from automated approvals? 3. What are the hidden data and documentation requirements for submissions to the new AI system? 4. How does this decision position Brazil against other LATAM markets like Mexico and Colombia? 5. What are the immediate actions MedTech companies should take to adapt their registration strategy? 6. Will this new system require changes to post-market surveillance and vigilance reporting? 7. How does this initiative align with Brazil's broader National AI Strategy? Navigating Brazil's rapidly evolving regulatory landscape requires local expertise and advanced technological tools. At Pure Global, we offer end-to-end regulatory consulting solutions, combining on-the-ground experts in Brazil with proprietary AI tools to streamline your market access. From regulatory strategy and dossier preparation to acting as your local representative, we help you leverage these new opportunities for faster growth. To learn how we can accelerate your entry into the Brazilian market, contact us at [e-mail] or visit https://pureglobal.com/.