UDI Submission Made Easy: Ensure Your Market Access in Saudi Arabia

Submission of UDI information in the Saudi-DI Database

As the Saudi Food and Drug Authority (SFDA) continues to advance patient safety and streamline medical device tracking, the implementation of the Unique Device Identifier (UDI) system has become essential for all manufacturers of medical devices and accessories who has their products registered and approved with the SFDA.

The SFDA has issued its guidance for the requirements related to the UDI submission (MDS-REQ 7) attached, and set the following effective dates based on the risk classification of the devices:

High-Risk Devices (Class D): Effective for registration – 1st September 2023
Medium-Risk Devices (Class B and C): Effective for registration – 1st September 2023
Low-Risk Devices (Class A): Effective for registration – 1st September 2024

Glimpse of the procedure for UDI submission:

The AR “Authorized Representative” that is responsible for the product registration, is the authorized party to do the submission of the UDI under their account.
There are two available options of the UDI submission, which are the (Individual submission) and the (Bulk submission).
The individual submission option is used when the manufacturer has small amount (Up to 10) of registered products/model numbers, using the attached general required UDI information, and the submission is done as individual applications for each UDI.
The Bulk submission option is used if we have huge number of products and to make the submission less complicated, where the SFDA has issued specific official templates that can be used and submitted as bulk file (Up to 150 UDIs in one file/template).
It’s required by the manufacturer to fill out the templates with the appropriate required information.