Brazil - Draft Resolution 1422, September 23, 2026 on Quality Assurance for Medical Device Processing Protocols

Business description

The Brazilian Health Regulatory Agency (ANVISA) has published Draft Resolution No. 1422 of September 23, 2026, establishing quality assurance guidelines for the development, validation, monitoring, and ongoing control of medical device processing protocols used by healthcare services and external processing companies. 

The proposed resolution seeks to improve consistency in device classification and processing, enhance patient safety, and reinforce requirements related to validation, traceability, accountability, and harmonized supervision within the National Health Surveillance System.​

Countries:
Brazil
Product categories:
05 Medical Devices
Technical aspects:
Safety
Business fields:
P.05 Medical
Regions:
South-America

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