Jun 23, 2022

The Saudi Food and Drug Authority (SFDA), Saudi Arabia’s medical device market regulator, has once again announced the postponement of its Unique Device Identification (UDI) requirements by one year, with compliance dates going into effect in phases, depending upon the risk class of the device.

The newest UDI compliance dates are:

  • September 1, 2023 for Class B, C and D devices
  • September 1, 2024 for low-risk Class A devices

Manufacturers of high-risk Class B, C and D devices previously faced a September 1, 2022 deadline and are the most impacted by the SFDA’s revised compliance timeline.

SFDA UDI guidance document gets new title

Additionally, the SFDA updated their UDI guidance (MDS-G34) to MDS-REQ7, Requirements for Unique Device Identification (UDI) for Medical Devices. While the title of this document changed, the requirements remain the same.

The Compliance Dates section of MDS-REQ7 states that “medical devices imported before compliance date can be distributed for one year after the compliance date.” According to Emergo by UL sources in Riyadh, this implies that devices imported before the compliance date can be distributed without UDI information for up to one year after the compliance date, though it is recommended to confirm this with your Emergo by UL representative or the SFDA if you think it may apply to your medical device risk class.

Emergo by UL consultants will post further details on SFDA UDI extensions as regulators release them.

Learn more about medical device regulations in Saudi Arabia:

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  • Kathryn Burke's picture
    Kathryn Burke

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