Latest / Medical Device Global Market Access
Brazil ANVISA Innovative Device Pilot Program 2026: A Guide for High-Risk MedTech
Brazil's ANVISA has opened a new pathway for innovative, high-risk medical devices. On August 5, 2026, the agency published Call Notice 5/2026, inviting manufacturers of Class III and IV devices with novel technologies to apply for a collaborative regulatory evaluation pilot program. This episode details the program's objectives, strict eligibility criteria (including AI-based devices and new biomaterials), the critical 30-day application window, and the strategic advantages of early engagement with ANVISA for accelerating market access in Brazil. Key Questions: - What is ANVISA's innovative…
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