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Saudi Arabia’s (SFDA): Requirements on Importation and Shipments of Medical Devices (MDS-REQ5)

Earlier today (21 May 2023) to ensure the importation and shipment of medical devices comply with rigorous standards, the Saudi Food and Drug Authority (SFDA) issued a comprehensive guidance document titled "Requirements on Importation and Shipments of Medical Devices (MDS-REQ5)".

Guidance is only available in Arabic (The English version is not available at the moment).

Medical device manufacturers, importers, and other stakeholders will be able to rely on this latest guidance to ensure that their products comply with the necessary regulatory requirements to ensure public health.

As described in the SFDA's MDS-REQ5 guidance, the importation and shipping of medical devices into Saudi Arabia must follow certain steps and requirements.

The primary goal is to offer healthcare providers and patients only safe, effective, and reliable medical devices.

Detailed information such as Licensing and Registration, Technical Documentation, labeling and Packaging, Quality Management System, Post-Market Surveillance, etc. are captured exclusively in this document.

By adhering to these requirements, the SFDA aims to safeguard public health, mitigate risks, and maintain high standards throughout the supply chain.

As the SFDA continues to prioritize the well-being of its citizens, this guide will serve as a cornerstone for a robust regulatory framework that adapts to the evolving landscape of medical devices.


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