Jan 21, 2020

With the Saudi Food and Drug Administration (SFDA) in the process of implementing a new regulatory system, medical device manufacturers active in Saudi Arabia will have some additional time to adjust.

Issued in December 2019, SFDA’s Announcement 11 specifies that manufacturers may continue to use the regulator’s reference market registration route—the only option before the SFDA rolled out its own system—past the original deadline of January 1, 2020. They now have until March 31, 2020 (not 2019, as printed in the English column of the announcement) to register or renew under the current system. This provides a respite to companies that may have failed to complete the process before the end of the 2019 calendar year.

GHAD migration deadline pushed back

The SFDA declined to publicize a second deadline extension, this time for submitting Medical Device Marketing Authorization (MDMA) applications using the old electronic system. With this and other application systems being integrated into the new unified GHAD electronic platform, manufacturers had been advised that any submissions not migrated to GHAD by December 26, 2019 would be deleted. In fact, these will remain accessible in the old system until January 26, 2019.

New guidance for innovative devices and standards

The SFDA also released two new guidance documents. MDS-G43 specifies the designation criteria for innovative medical devices and outlines a priority review procedure for them, with the stated intention of maintaining both safety evaluation and rapid market access. MDS-G44 lists over 350 standards recognized by the SFDA that can be used in support of premarket submissions.

Stay tuned for further regulatory updates and guidance documents as the SFDA continues to roll out and fine-tune its new regulatory system.

Related Saudi Arabia medical device market resources from Emergo by UL: