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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:

ComponentDescription
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​