What is UDI
The Unique Device Identification (UDI) is a global system that assigns each medical device a unique code, readable by humans and machines. The goal: end-to-end traceability, from manufacturer to patient.
Countries like the United States (FDA) and European Union (MDR) have already implemented their UDI systems. Brazil joined the model via RDC 591/2021 — now updated by RDC 884/2024.
What ANVISA is
The Brazilian Health Regulatory Agency (ANVISA) is the equivalent of the FDA — the federal body that regulates medical devices sold in Brazil.
What changes with RDC 884/2024
- Phased implementation timeline by risk class (III, IV → first; II → second; I → last)
- National database (BD-UDI) hosted by ANVISA, integrated with global systems
- Code format — DI (Device Identifier) + PI (Production Identifier)
- Coding technology — linear codes, DataMatrix or RFID, depending on the case
- Label + packaging + machine-readable UDI
Next steps
Implementation follows a schedule by risk class:
- Class III and IV (implantable devices, high risk) — initial phase, shorter deadlines
- Class II (medium risk) — intermediate phase
- Class I (low risk) — final phase
Each company must verify the class of its devices and the corresponding deadline.
Importers representing foreign manufacturers must coordinate with the registration holder abroad — the UDI code issued internationally must be communicated to the Brazilian BD-UDI.
What your company needs to do
- Device inventory — list all current registrations and their classes
- Identify DI issuer — GS1, HIBCC or ICCBBA (depends on product)
- Adapt labeling — include UDI in primary, secondary packaging and, when applicable, on the device itself
- Register in BD-UDI — submit information per ANVISA guidance
- Integrate with internal systems — ERP, quality management, traceability
Non-compliance with UDI deadlines subjects the company to sanitary sanction, with possible commercialization suspension until regularized.
For foreign manufacturers
If you already operate under FDA UDI or EU MDR, much of the technical foundation is in place — the same GS1 / HIBCC codes can be used. The Brazilian implementation requires registration in the local BD-UDI database, but doesn't duplicate the technical work you've already done abroad.
Working with a local Holder or specialized regulatory consultancy simplifies the cross-border alignment.