Brazil's New e-Notivisa System: ANVISA's Overhaul of Medical Device Adverse Event Reporting

Medical Device Global Market Access · Jul 10, 2026 · 4m

On July 1, 2026, Brazil's ANVISA mandated the use of its new e-Notivisa system for all medical device adverse event reporting, replacing the legacy NOTIVISA platform. This episode details the critical changes, including the adoption of the International Medical Device Regulators Forum (IMDRF) adverse event coding, which aligns Brazil's technovigilance requirements with global standards. We discuss the implications for manufacturers and Brazil Registration Holders (BRHs) and provide practical steps for updating quality systems, training teams, and ensuring compliance with the new structured…