Saudi FDA moves to single electronic platform for medical device registrations

Saudi Arabia’s Saudi Food and Drug Authority (SFDA) have rolled out a single registration platform for all medical device market authorization, authorized representation and related applications to be submitted to the regulator.

The new system, Ghad, provides a single platform for submitting Medical Device Marketing Authorization (MDMA), Medical Device National Registry (MDNR), Saudi Authorized Representative and related applications to SFDA. Previously, Saudi Arabia market applicants had to utilize individual systems to submit MDMA, MDNR and other applications to Saudi regulators.

Deadlines for migration to Ghad

According to SFDA, Saudi medical device market registrants and in-country representatives face a December 26, 2019 deadline to open Ghad accounts and transfer both existing and in-process applications over to the new system. Following that deadline, any applications not yet migrated to Ghad will be cancelled.

Implications for SFDA medical device registration going forward

The launch of Ghad lays more groundwork for SFDA’s anticipated overhaul of Saudi Arabia’s medical device regulatory system in early 2020. Additional details on Ghad implementation as well as SFDA regulatory changes will be posted as we learn them.

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

• SFDA medical device registration and approval consulting
• Saudi Authorized Representative in-country representation
• Process chart: SFDA medical device registration requirements