Brazil - Draft Resolution 1.421, September 23, 2026 on Good Practices for Medical Device Processing
Business description
The Brazilian Health Regulatory Agency (ANVISA) has published Draft Resolution No. 1,421 of September 23, 2026 on Good Practices for Medical Device Processing, establishing Good Practice requirements for companies that process medical devices on behalf of healthcare facilities.
The proposed regulation seeks to enhance patient safety by promoting consistency in device classification and processing, strengthening validation and traceability requirements, clarifying responsibilities, and supporting 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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