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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.
Last updated on January 12th, 2022.
Medical Device Regulations and Classification in UAE
REGULATORY AUTHORITY: Ministry of Health and Prevention (MOHAP)
CLASSIFICATION SYSTEM: Medical Device: I/II/III/IV IVD: A/B/C/D
TIMEFRAME:
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.
LICENSE VALIDITY: 5 years
AUTHORIZED REPRESENTATIVE: Foreign manufacturer must appoint a company residing within the UAE to act as their Authorized Representative (AR).
For detailed device-specific compliance information for each market, including UAE, to expedite the preparation of your medical device or IVD registration application.
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