Saudi Arabia – KSA update: New Saudi medical device regulation, GHTF applications, AI requirements, and more

The Kingdom of Saudi Arabic (KSA) officially introduced a new regulation governing medical devices, which is slated to take effect later this year. In related news, the Saudi Food and Drug Administration (SFDA) extended the use of the GHTF expedited market access route and published a guidance document on artificial intelligence in medical software and an updated classification guidance. Details follow in this roundup of recent Saudi regulatory developments.

Saudi royal decree establishes new medical device regulation

The Saudi government issued Royal Decree No. (M/54) (links in Arabic), approving the new overarching Medical Devices and Supplies Regulation to replace the Medical Devices Interim Regulation

The new regulation retains most of the provisions of the interim regulation and serves as the fundamental basis of the SFDA’s authority to regulate medical devices. It reinforces the need for all medical devices to obtain market authorization, except certain devices identified by the SFDA to be demonstrably safe and not intended for commercial purposes. It also allows the SFDA to exclude innovative medical devices from some of the conditions and procedures required to obtain market authorization.

The new regulation will take effect 180 days from the date of publication…