Brazil's SaMD Cybersecurity Shockwave: Pure Global on ANVISA's Hidden Demands.

Last week, Brazil's ANVISA unleashed a pivotal update for Software as a Medical Device (SaMD) with its new resolution, RDC 992/2025. While appearing to align with international standards, this new regulation introduces complex cybersecurity and data privacy requirements tied specifically to Brazil's LGPD law, creating unexpected hurdles for global manufacturers. In this episode of LATAM MedTech Insights, we dissect the fine print of ANVISA's new rules. We explore the immediate operational impacts, from mandatory local data protection officers to new clinical data requirements for AI-driven software, and discuss the strategic adjustments companies must make to maintain or gain market access in Latin America's largest market. Case Study: Imagine you're a US-based scaleup with a groundbreaking AI diagnostic tool. Your EU MDR and FDA clearances are in hand, and Brazil is your next target. Suddenly, your registration is stalled. Why? Your application didn't address specific LGPD data transfer protocols and your designated data officer isn't based in Brazil. This is the new reality—a costly and time-consuming roadblock that a standard regulatory checklist would have missed. Key Takeaways: 1. What are the three 'hidden' requirements in ANVISA's new SaMD rule that most foreign companies will miss? 2. How does Brazil's LGPD law now directly impact your medical device's technical file? 3. Is your current cybersecurity plan sufficient for the new Brazilian standards? 4. Why might your existing AI/ML validation data be rejected by ANVISA? 5. What's the new mandatory role you might need to hire in Brazil to keep your SaMD on the market? 6. How does this update affect legacy SaMD products already registered in Brazil? 7. What are the critical deadlines you cannot afford to ignore over the next six months? Navigating the evolving regulatory landscape in Latin America requires more than just a checklist; it demands localized, expert strategy. At Pure Global, we offer end-to-end regulatory consulting for MedTech and IVD companies, combining deep local expertise with advanced AI tools to streamline your global market access. We act as your local representative, manage your technical dossier, and ensure continuous compliance. Don't let regulatory surprises derail your expansion. Contact us at [e-mail] or visit https://pureglobal.com/ to secure your market presence.