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. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including UAE, to expedite the preparation of your medical device or IVD registration application.

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).

Last updated on April 20, 2021.

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