Brazil ANVISA SaMD & AI Vigilance Rules: Mid-October 2026 Feedback Deadline

Medical Device Global Market Access · Oct 14, 2026 · 4m

Brazil's ANVISA has launched Public Call No. 4/2026 to revise its Tecnovigilância (post-market vigilance) framework, specifically seeking industry feedback on the challenges posed by Software as a Medical Device (SaMD) and AI. This episode breaks down the proposal, who is affected, and the urgent mid-October 2026 deadline for manufacturers to submit comments and influence the future of digital health regulation in this key Latin American market. Key Questions: - What is ANVISA's Public Call No. 4/2026 and why is it critical for SaMD manufacturers? - How are AI and machine learning changing…