Oct 26, 2021

The Saudi Food and Drug Authority (SFDA), Saudi Arabia’s medical device market regulator, has revised compliance timeframes regarding the country’s Unique Device Identification (UDI) system.

According to Emergo by UL sources in Riyadh, revised UDI compliance deadlines depend upon devices’ risk classifications under the SFDA regulatory system:

  • September 1, 2022 for Class B, C and D devices
  • September 1, 2023 for low-risk Class A devices

High-risk Class D device manufacturers previously faced an August 1, 2021 deadline for UDI compliance, and stand to be the most impacted by the SFDA’s revisions.

Emergo by UL consultants will provide further details on the SFDA UDI extensions as the regulator releases them.

Learn more about medical device regulations in Saudi Arabia:

Author

  • Stewart Eisenhart

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