Even in Saudi Arabia as of September 1, 2023, manufacturers must implement unique device identification (UDI) requirements for placing Class B, C and D devices on the market in the territory. For Class A devices, the obligation will start on September 1, 2024, while there is an exemption for custom-made Medical Devices or devices intended for clinical investigations.
Originally defined on 08/01/2021 with the entry into force of the UDI system, the deadlines were extended to the beginning of 2023 by one year compared to the deadlines initially set by SFDA (Saudi Food and Drug Authority), the Saudi Arabian Regulatory Authority for Medical Devices and IVDs.
The reference document is the MDS – REQ 7 Requirements for Unique Device Identification (UDI) for Medical Devices (ex MDS-G34), which also specifies that devices imported before the compliance date may be distributed without UDI information on Saudi territory until one year after the date of full enforceability.
As it is already well known, the UDI is a unique numeric or alphanumeric code associated with a medical device, which allows devices placed on the market to be clearly and unambiguously identified and facilitates their traceability.
As far as the Saudi Arabian market is concerned, the manufacturer must declare which agency (GS1, HIBCC and ICCBBA) has assigned the UDI-DI codes and it shall be entered into the SaudiDI database. Thi database can be used from 08/01/2020. The UDI-PI cannot be entered into the database, and it includes the batch or serial number, software version, expiry or production date, and other useful information.
The Local Representative is obliged to enter and update information on the SaudiDI database for all devices marketed in Saudi Arabia and to validate the UDI data at least annually during the marketing period.
The obligations resulting from the implementation of the UDI system imposed by the Saudi Food and Drug Authority (SFDA) on Manufacturers and Local Representatives are intended to provide standardised device identification. Specifically, the information collected could be used for several public health initiatives, including device traceability; accurate identification of fraudulent devices; management of data in case of recalls, corrective actions and adverse events; establishment of efficient controls during the entire device life cycle; and ensuring that devices are used efficiently and safely.
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