ANVISA is moving fast on international cooperation, the SIUD UDI database, and software-as-a-medical-device classification. The next 18 months are a strategic window for MedTech sponsors using Brazilian clinical data.
ANVISA’s 2026–2027 International Convergence Agenda: What MedTech Sponsors Need to Plan For Brazil’s medical device regulator, ANVISA, is in the middle of the most aggressive period of international regulatory convergence in its history. Between the mid-2024 Brazilian Clinical Research Law (Lei 14.874) becoming fully operative on January 1, 2025, and the agency’s published 2026–2027 priorities, the rules around clinical trial submissions, post-market surveillance, software as a medical device (SaMD), and unique device identification (UDI) are all changing simultaneously. For MedTech sponsors planning to use Brazilian clinical data in US, EU, or Brazilian regulatory submissions, the next 18 months are a strategic window. Here is what is changing, why it matters, and how to plan for it. What Is Actually Changing Three convergence streams are running in parallel. 1. Stronger international cooperation on device review. ANVISA has expanded its participation in internation…