UDI — Unique Device Identification
What is UDI?
Unique Device Identification (UDI) is a system for labelling and tracking medical devices through the distribution and use chain. The SFDA's UDI requirements are set out in MDS-REQ 7 and require manufacturers to assign a UDI to each device and submit UDI data to the SFDA system.
UDI structure
A UDI consists of two components:
| Component | Description |
|---|---|
| Device Identifier (DI) | Fixed portion — identifies the device model, version, and packaging configuration; same for all units of the same device |
| Production Identifier (PI) | Variable portion — identifies the specific unit or batch (lot number, serial number, expiry date, manufacturing date) |
Both the DI and PI must appear on the device label in human-readable format. Machine-readable format (barcode or RFID) is also required for most device classes.
SFDA UDI vs. US FDA and EU UDI — key differences
The SFDA's UDI requirements are aligned with international UDI principles but have Saudi-specific implementation details that differ from US FDA (21 CFR Part 830) and EU MDR/IVDR UDI:
- SFDA uses its own GHAD UDI submission portal (not GUDID or EUDAMED)
- Compliance timelines and phasing differ from US and EU schedules
- Specific data fields required for SFDA UDI submission may differ from FDA/EU requirements
Manufacturers who have already implemented UDI for US or EU markets should carefully review MDS-REQ 7 to identify SFDA-specific differences.
Who must comply?
All medical device manufacturers holding an MDMA are subject to SFDA UDI requirements. UDI compliance is phased — see UDI Compliance Timeline.
Further reading
- MDS-REQ 7 — UDI requirements
- UDI Data Submission
- UDI Labelling Requirements
Manufacturers must first obtain a valid MDMA certificate and register with the GHAD portal before submitting UDI data. UDI assignment cannot occur prior to MDMA approval. Ensure your Authorized Representative has active GHAD portal access before initiating UDI data submission.