UDI Implementation — Brazil ANVISA Unique Device Identification Requirements
ANVISA is implementing a UDI framework for medical devices in Brazil, aligned with the international IMDRF UDI guidance. The programme requires manufacturers to assign Unique Device Identifiers to applicable devices and submit UDI data to ANVISA's systems.
Implementation is phased — higher-risk device classes (Class III and IV) face earlier mandatory deadlines, with Class I and II to follow. Manufacturers should monitor ANVISA's official publications in the Diário Oficial da União for applicable compliance dates for their device categories.
🔖 Status: phased implementation in progress
Manufacturers exporting to Brazil should work with their Brazilian importer to understand the UDI timeline applicable to their specific product Registration. ANVISA has issued guidance on accepted UDI issuing agencies (GS1, HIBC) and label placement requirements.
View official source (ANVISA) ↗