Brazil Traceability System — Current Status & Roadmap
BR-unique
Brazil is in the process of developing a national medical device traceability system (sistema de rastreamento) aligned with the IMDRF UDI (Unique Device Identification) framework. As of May 2026, full UDI implementation is not yet mandatory for all device classes in Brazil — ANVISA has published proposals and is running public consultations on the topic.
Current traceability requirements
While a comprehensive UDI system is not yet fully implemented, current Brazilian requirements mandate:
- Lot/batch numbers on all devices (labels);
- Distribution records maintained by manufacturers, importers, and distributors;
- Implant records for Class IV implantable devices (patient-level traceability); and
- NOTIVISA reporting linking adverse events to specific device batches.
The ANVISA UDI roadmap
ANVISA has been consulting with industry on adopting a UDI system aligned with IMDRF guidance. Monitor the What's New section for updates on UDI implementation timelines.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.