Saudi Regulators Confirm New Regulations for Some Low-risk Medical Devices
EMERGO SUMMARY OF KEY POINTS:
- The Saudi Food and Drug Authority (SFDA) has officially announced a new market pathway for Class I non-sterile, non-measuring devices that does not require Medical Device Marketing Authorization (MDMA).
- Qualifying low-risk device manufacturers may list their products in the Saudi Medical Device National Registry (MDNR) in lieu of MDMA premarket review.
- Implementation timeframes for the new non-MDMA market pathway have not yet been disclosed.
Medical device regulators in Saudi Arabia have officially confirmed plans to exempt certain Class I low-risk devices from full registration requirements.
As previously reported by Emergo, the Saudi Food and Drug Authority had disclosed plans to exempt Class I non-sterile, non-measuring devices from Medical Device Marketing Authorization (MDMA) registration rules. Now, the SFDA has announced to affected parties that sponsors of qualifying Class I devices may choose standard or expedited market pathways in order to commercialize their products in Saudi Arabia. (SFDA has yet to publish the announcement on its website.)
Standard MDMA route
First, Class I non-sterile, non-measuring device manufacturers and sponsors may choose a standard registration route whereby they submit MDMA applications to SFDA for review, and then once approval is obtained, list their devices in the Saudi Medical Device National Registry (MDNR).
Class I non-sterile, non-measuring device manufacturers now also have the option of having their products listed in the MDNR by their importers or distributors in order to begin marketing efforts in Saudi Arabia, without undergoing MDMA review.
MDNR listing information requirements include product and manufacturer information, indications for use, proof of quality system compliance and reference market authorization, and labeling data. Official SFDA timeframes for MDNR listing applications are 10 business days; approved listings are valid for three years.
Saudi authorized representation required either way
Regardless of whether a foreign Class I non-sterile, non-measuring device manufacturer opts for the MDMA or the faster MDNR market authorization route, SFDA still requires market applicants to appoint a Saudi Arabia Authorized Representative to manage their registrations.
Effective date to be determined
The SFDA announcement does not disclose when Saudi regulators plan to implement the new non-MDMA route for low-risk Class I device registrants. Emergo consultants in Riyadh will provide this information as soon as they learn it from SFDA officials.
Related medical device regulatory resources for Saudi Arabia:
- SFDA registration and approval consulting for medical device companies
- Saudi Arabia Authorized Representative in-country representation
- Certificate of Free Sale (CFS) service for medical device exports
- Video overview: Saudi Arabia’s medical device registration process
- Whitepaper: SFDA medical device registration