EMERGO SUMMARY OF KEY POINTS

• Low-risk medical device manufacturers may now choose between Medical Device Market Application (MDMA) and Medical Device National Registry (MDNR) registration pathways in Saudi Arabia.
• The SFDA’s MDNR route is faster, but some Class I non-sterile, non-measuring device manufacturers may still benefit more by undergoing MDMA registration.

Now that Saudi Arabian medical device regulators have exempted some low-risk products from full registration requirements, qualifying manufacturers should consider whether standard or fast-track access to the Saudi market best suits their business needs.

For manufacturers of Class I non-sterile, non-measuring devices, the Saudi Food and Drug Authority (SFDA) now offers two market pathways: the standard Medical Device Market Application (MDMA) route, which entails full premarket review, and the Medical Device National Registry (MDNR) expedited route, which bypasses full regulatory review. However, some manufacturers may find the standard MDMA route more advantageous than the MDNR route.

Below, we discuss the advantages and disadvantages of each SFDA registration route for Class I non-sterile, non-measuring device companies according to information from Emergo sources in Riyadh.

MDNR: Faster is better, sometimes

By providing expedited Saudi market access would seem the optimal route for low-risk medical device manufacturers. But firms should weigh the following factors carefully when deciding which route would work best for their commercialization plans.

Benefits of the MDNR route include foregoing full SFDA premarket review and approval, and faster overall registration timeframes. Plus, the MDNR application process is the responsibility of a device importer or distributor, not the manufacturer, and qualifying devices may have multiple MDNR listings with different distributors.

However, manufacturers should bear in mind that:

• The MDNR route does not allow bundling of devices under single registrations; devices and accessories must be registered individually, with fees assessed for each registration;
• MDNR devices that undergo changes will be subject to new SFDA registration requirements; SFDA currently has no process in place to modify or update MDNR registered products;
• No official SFDA guidance on MDNR registration has yet been issued by the regulator.

MDMA: Slower but steadier

MDMA review by Saudi regulators involves submitting more registration documents and longer market authorization timelines, as well as hiring a Saudi Arabia Authorized Representative to manage your registration process. These requirements may seem more onerous than those of the MDNR route for some smaller manufacturers, but firms seeking to bring more than one device to market in Saudi Arabia may find the MDMA option less costly.

Advantages of MDMA registration include:

• Bundling or grouping multiple devices and their accessories under a single MDMA application
• MDMA registrations may be updated if there are changes to devices or their accessories
• An MDMA registration is issued to the manufacturer, and may be utilized by all that manufacturer’s Saudi distributors and importers

More information on medical device regulations in Saudi Arabia:

• SFDA medical device registration consulting
• Saudi Arabia Authorized Representative in-county representation
• Certificate of Free Sale (CFS) support for medical device exports
• Whitepaper: Saudi Arabian medical device registration requirements