Unique Device Identification (UDI) Framework
What is UDI?
A Unique Device Identifier (UDI) is a unique numeric or alphanumeric code that identifies a medical device on the market. A UDI system enables:
- Accurate device identification throughout the supply chain
- Rapid, targeted recalls (lot-specific, model-specific)
- Post-market surveillance and adverse event analysis
- Prevention of counterfeit devices entering the supply chain
IMDRF UDI framework
Health Canada's UDI approach follows the IMDRF UDI framework, which defines a two-part structure:
| Component | Description |
|---|---|
| Device Identifier (DI) | Identifies the device model/version — does not change unless the device changes |
| Production Identifier (PI) | Identifies the specific production unit (lot number, serial number, expiry date, manufacturing date) |
The DI + PI together form the complete UDI.
Issuing agencies (accredited by Health Canada)
Manufacturers may obtain a UDI from any Health Canada-accredited issuing agency:
- GS1 (most widely used globally)
- HIBCC (common in hospital supply chains)
- ICCBBA (common for blood and tissue products)
Status of Canadian UDI regulations
As of May 2026, Health Canada's UDI framework was still in development, with final regulations anticipated. Manufacturers with UDI in place for FDA (GUDID database) or EU (EUDAMED) will find the Canadian requirements very similar — the goal is full international harmonisation.
What manufacturers should do now
- Implement UDI for FDA and EU markets if not already done — Canadian requirements will be aligned
- Use GS1 or HIBCC as your issuing agency — both will be accepted in Canada
- Track UDI requirements on the Canada Gazette — final regulations will include implementation timelines and class-based phase-in periods
- Engage with Health Canada consultation when the next round opens
Official source