Medical Device Registration and Approval in UAE

General country-specific regulatory information is provided on this page for medical device registration and approval in UAE.

We review our Regulatory Information frequently; please check back often for updates

Medical Device Regulations and Classification in UAE

REGULATORY AUTHORITY: Ministry of Health and Prevention (MOHAP)
Official Timeline
Product Classification – 10 working days
Manufacturer Registration License – 14-28 working days
Product Registration – 45 working days
Actual Timeline – based on experience
Product Classification – 14 working days
SPECIAL REQUIREMENTS: Local testing is not required. All manufacturers should register their manufacturing facility as part of device registration process. Manufacturers of class III or IV devices may be subject to an onsite audit and inspection.
LOCAL FEES (New Application) Product Classification – USD 136 Manufacturer Registration License – USD 2859 Product Registration – USD 1360
LOCAL FEES (Manufacturer): The Authorized Representative must be licensed by MOHAP and the facility they possessed must have one pharmacist in charge (PIC) with a License to Practice as a Pharmacist in UAE, and who is also responsible for the facility. The fees required for this license is around USD 2590.
AUTHORIZED REPRESENTATIVE: Foreign manufacturer must appoint a company residing within the UAE to act as their Authorized Representative (AR).

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For detailed device-specific compliance information for each market, including UAE, to expedite the preparation of your medical device or IVD registration application.


Did you know you can onboard your medical device or IVD compliance information to our system in less than 15 minutes?

And, in less than a minute, you can start your device-specific registration application and a complete county-specific registration process in this country or any of the other 140+ countries available for you through the Arazy Group Medtech registration platform.

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