The SFDA (Saudi Food and Drug Authority, the Saudi Arabian Regulatory Authority for Medical Devices and IVDs) announced a one-year postponement of the requirements’ implementation for unique device identification, i.e., the UDI system.

The extension and the corresponding timeframe for ensuring compliance with the UDI system are as follows:

• 1^st September 2022 for class B, C and D devices > postponed to 1^st September 2023
• 1^st September 2023 for class A devices (low risk) > postponed to 1^st September 2024

The purpose of the UDI requirements and associated database is to provide a standardised identification of Medical Devices. The associated device-specific meta-data will support various public health and safety initiatives, including device traceability, identification of fraudulent Medical Devices, safety alerts, field safety corrective actions, reporting of incidents and adverse events, etc.

The reference document is MDS-REQ7 (previously MDS-G34), Requirements for Unique Device Identification (UDI) for Medical Devices, which, in addition to the above, specifies that Medical Devices imported before the compliance date may be distributed without UDI information on Saudi territory up to one year after the date of full enforceability.

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SOURCES:

https://www.sfda.gov.sa/sites/default/files/2022-06/RequirementsUDI_0.pdf