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UDI Data Submission & Compliance Timeline

Submitting UDI data to the SFDA​

UDI data must be submitted to the SFDA via the GHAD portal. Required data fields include:

  • Device Identifier (DI) — device model level
  • Device name and generic name
  • Device description
  • Risk class
  • Applicable standards
  • Manufacturer and AR information
  • Labelling information (sterile, measuring, single-use, implantable flags)
  • MDMA certificate number

UDI data must be submitted before the device is first placed on the Saudi market, and updated whenever UDI-relevant device information changes.

Compliance timeline by device class​

The SFDA phases UDI compliance requirements by device class, with higher-risk classes required to comply first. The SFDA publishes the current phased timeline on its website.

Check current SFDA timeline

UDI compliance deadlines are subject to update. Always verify the current phased timeline on the SFDA website or via MDS-REQ 7 updates.

Maintaining UDI data​

After initial submission, UDI data must be kept current in GHAD:

  • Update the DI record when device details change (name, configuration, intended use)
  • Update PI data when production identifiers change
  • Notify SFDA via GHAD of any UDI-relevant changes

Further reading​