Saudi Arabia is the largest medical device market in the Gulf and one of the most active for O&P, foot health and rehabilitation products. We take manufacturers and distributors through every Saudi Food and Drug Authority (SFDA) step, from classification to tender-ready listing.
What the SFDA expects
- A Medical Device Marketing Authorisation (MDMA) for every device, whatever its risk class (A to D)
- A licensed Authorised Representative in the Kingdom for every foreign manufacturer
- Registration on the Medical Devices National Registry (MDNR) and Saudi-DI / UDI compliance
- Separate licences for importing, distributing and advertising medical devices
- Renewal of the MDMA before it expires, against the current requirements, not the ones in force when it was first issued
How we help
- Product classification through the SFDA Product Classification System
- MDMA dossiers built from your existing CE, FDA or other approvals
- Authorised Representative licensing and AR transfers between partners
- Import and distribution licensing, logistics and supply-chain compliance
- Medical Device Advertising Licence (MDAL) applications
- UDI, vigilance and post-market surveillance set-up
- MDMA renewals and change notifications
- SABER and SASO conformity for non-medical products such as comfort footwear, mobility and daily-living aids
- NUPCO and hospital tender readiness, with our commercial team
Delivered by Deliberate
Starband: SFDA MDMA for the full range of cranial remoulding orthoses and post-surgical helmets, all Class II devices, registered within six months starting from a weak original technical file for each helmet design.
Landis: SASO and SABER registration as non-medical equipment, supported by CSA equipment testing, for import into Saudi Arabia.
TurboMed Orthotics: ISO 13485 with TÜV Austria and SFDA MDMA for an external AFO, both within two months on a lean, fixed budget.
Talk to us about Saudi Arabia
Tell us your device, its classification today and where it is already approved, and we will map the fastest compliant route.
