As of September 1, 2023, Saudi Arabia has mandated the implementation of Unique Device Identification (UDI) requirements for Class B, C, and D medical devices within its territory. Class A devices will follow suit starting September 1, 2024, with exemptions in place for custom-made medical devices or those designated for clinical investigations. This move, initiated by the Saudi Food and Drug Authority (SFDA), seeks to enhance device traceability, safety, and overall public health initiatives within the kingdom.
Originally set to commence in 2022, the UDI system’s enforcement deadlines were extended by a year, allowing manufacturers an extended window for compliance. Referencing the MDS – REQ 7 Requirements for Unique Device Identification (UDI) for Medical Devices, manufacturers are required to obtain UDI-DI codes from recognized agencies such as GS1, HIBCC, or ICCBBA. These codes are to be registered in the SaudiDI database, established since August 1, 2020, facilitating clear identification and traceability of devices placed on the Saudi market.
Notably, devices imported before the compliance date may be distributed within Saudi Arabia without UDI information until one year post the full enforceability date. However, the Local Representative bears the responsibility of entering and updating device information on the SaudiDI database for all marketed devices, validating UDI data at least annually during their tenure in the market.
The implementation of UDI by the SFDA aims to standardize device identification, enabling various public health initiatives. These include efficient device traceability, identification of counterfeit devices, effective management of recalls, corrective actions, and adverse events, robust lifecycle controls, and ensuring devices’ safe and efficient usage.
The UDI system’s establishment marks a significant stride in the realm of medical device regulation in Saudi Arabia. It not only fosters a more transparent and accountable medical device market but also strengthens measures to safeguard public health and safety across the kingdom.
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