From our base in the UAE we register O&P, foot health and rehabilitation products across the Gulf and coordinate a single submission plan for Saudi Arabia, the UAE, Oman, Kuwait, Qatar and Bahrain.
UAE: the Emirates Drug Establishment
Medical device registration in the UAE moved from the Ministry of Health and Prevention (MoHAP) to the Emirates Drug Establishment (EDE), which is now the federal authority for device classification, marketing authorisation, manufacturer registration, import permits, advertising approvals and vigilance. Submissions are made through the EDE digital portal.
- Classification and registration of manufacturers and products with the EDE
- Migration and verification of existing MoHAP registrations
- Local representation and distributor set-up, including company formation in a free zone
- Advertising approvals and vigilance procedures
- Emirate-level requirements for clinics and hospitals in Dubai and Abu Dhabi
Across the GCC
- Oman, Kuwait, Qatar and Bahrain registrations, sequenced with your Saudi and UAE files
- One technical file, adapted to each authority, so you are not paying for the same work twice
- Distributor search and appointment in each market through our commercial team
Delivered by Deliberate
MoHAP registration in the UAE and SFDA MDMA in Saudi Arabia.
Talk to us about the UAE and GCC
Tell us your device, its classification today and where it is already approved, and we will map the fastest compliant route.
