São Paulo SaMD Shake-Up: Pure Global on ANVISA’s Unwritten Rules for AI

Brazil's MedTech landscape is buzzing as its regulatory agency, ANVISA, puts Software as a Medical Device (SaMD) back under the microscope. In its newly released 2024-2025 agenda, ANVISA has signaled major revisions to the existing framework, a move that comes sooner than many in the industry expected. This suggests that the initial guidelines are already being outpaced by rapid advancements in digital health, especially in AI and machine learning. This episode dives deep into the implications for MedTech manufacturers. While Brazil's alignment with international standards has created opportunities, navigating the specifics of its regulatory environment remains a complex challenge. For companies with innovative SaMD, particularly those leveraging adaptive AI, the upcoming changes could mean the difference between market leadership and costly compliance failures. We explore what these revisions might entail and how companies can prepare for a more stringent regulatory future. A real-world example: A US-based scaleup has a powerful AI-driven diagnostic platform. Their biggest pain point is regulatory ambiguity. They are uncertain if their adaptive algorithm fits ANVISA's current risk classification and are struggling to prepare cybersecurity documentation that will satisfy local requirements, which differ from those of the FDA. This uncertainty is delaying their entry into one of LATAM's largest markets, costing them valuable time and revenue. What you'll learn in this episode: 1. Why is ANVISA revisiting its SaMD regulations so soon after the 2022 framework was established? 2. What are the three key areas, including AI and cybersecurity, likely to see the strictest new rules? 3. How does Brazil's approach to classifying adaptive AI software differ from the EU or US? 4. What are the most common documentation gaps that lead to SaMD registration delays in Brazil? 5. Is your current change control process robust enough for ANVISA's evolving expectations? 6. How can you leverage your existing international technical files for a faster Brazilian submission? 7. What are the unspoken post-market surveillance challenges unique to digital health in LATAM? 8. How do you determine if a software update is a minor change or requires a completely new registration? Ready to streamline your market access in Brazil and beyond? Pure Global offers end-to-end regulatory consulting solutions, combining local expertise with advanced AI to accelerate your success. Contact us at [e-mail] or visit https://pureglobal.com/ to learn how we can be your local partner for global growth.