Healthcare, Industry News, Medical Devices, Regulatory Affairs

Guidance on Unique Device Identification (UDI) system in Saudi Arabia

The Saudi Food and Drug Authority (SFDA) has issued guidance on establishing a Unique Device Identification (UDI) system in Saudi Arabia. The guidance covers all medical devices and accessories registered in Saudi Arabia, with the exception of custom-made devices as well as investigational medical devices and IVD devices.

The UDI requirements listed by SFDA, generally in line with International Medical Device Regulators Forum (IMDRF) recommendations and systems implemented in the US and other markets, include the following:

  • A device identifier (UDI-DI) and a production identifier (UDI-PI) assigned to each device;
  • UDI data available in both plain text and AIDC technology formats;
  • Reusable devices should have permanent direct marking (DM) UDI information;
  • New UDI-DI data will be required when a device or its attributes undergo changes or modifications

SFDA’s UDI system will also entail a database, the Saudi Arabia UDI Database (SAUDI-D), where manufacturers or their Authorized Representatives will be required to submit and maintain UDI-related data.

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