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.
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