Brazil ANVISA Medical Device Vigilance: Public Call on SaMD and AI Rules

Medical Device Global Market Access · Sep 27, 2026 · 5m

Brazil's ANVISA has opened Public Call No. 4/2026, seeking industry feedback on a major revision of its medical device post-market vigilance (Tecnovigilância) framework. With a specific focus on the challenges posed by Software as a Medical Device (SaMD) and AI, this consultation offers a critical opportunity for manufacturers to influence future regulations. This episode breaks down the scope of the proposed changes, the strategic importance of participating, and the key deadline of mid-October 2026 for submitting feedback. Key Questions: - What is ANVISA's Public Call No. 4/2026 about? -…