ANVISA UDI Alignment with IMDRF Framework
ANVISA is progressively aligning its traceability requirements with the international UDI (Unique Device Identification) framework developed by IMDRF. The IMDRF UDI system uses a two-component structure:
| Component | Description |
|---|---|
| Device Identifier (DI) | Fixed portion identifying the device model/version |
| Production Identifier (PI) | Variable portion identifying the specific unit — lot/batch, serial number, expiry date |
Accepted issuing agencies for UDI include GS1, HIBCC, and ICCBBA — the same agencies used in the EU, US, and other major markets. This means that devices already carrying a UDI for EU or US regulatory requirements can use the same identifier for Brazilian compliance (subject to ANVISA confirming acceptance).
Monitor ANVISA's Peticionamento Eletrônico portal for UDI implementation updates.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.