Credentials

The formal foundations of our authority.

Licensed by the Saudi Food and Drug Authority, certified to ISO 13485:2016 and registered in the Kingdom.

SFDA-licensed consultancy office

Consultancy Office License CO-2026-FO-0007 from the Saudi Food and Drug Authority, covering regulatory consulting for medical devices.

SFDA-licensed Authorized Representative

Licensed by the Saudi Food and Drug Authority to act as AR for overseas medical device manufacturers.

ISO 13485:2016 certified

Our operations are fully aligned with the international quality standard for medical device organisations.

Saudi commercial registration

A registered Saudi business entity, C.R. 7017200762, with full legal standing for all regulatory activities.

GCC regulatory network

Active in GCC regulatory networks and professional associations, close to every regional development.

SFDA licence

Licensed by the Saudi Food and Drug Authority.

IREG holds an SFDA Consultancy Office License for regulatory consulting on medical devices. The licence below is the one issued to us by the SFDA.

Licence number
CO-2026-FO-0007
Issued to
Intelligent Regulations Medical Establishment
Scope
Consulting services in medical device regulation
Valid
6 May 2026 to 5 May 2031
SFDA Consultancy Office License CO-2026-FO-0007, issued to Intelligent Regulations Medical Establishment
Start with step one

Book an initial consultation.

Tell us about your portfolio and timeline. A specialist will map the regulatory pathway with you.

Talk to a specialistinfo@i-regulations.com
+966 53 530 0129