MEDICAL DEVICE REGISTRATION AND APPROVAL IN UAE

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 update: January 2024

Medical Device Regulations and Classification in UAE

REGULATORY AUTHORITY: The Ministry of Health and Prevention regulates Medical Devices in UAE.

CLASSIFICATION SYSTEM: UAE has a classification system that consists of four classes: A, B, C, and D. Generally, they consist of the EU classification system (I, IIa, IIb, III).

TIMEFRAME: 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: NA.

AUTHORIZED REPRESENTATIVE: A local license holder is required.

ADDITIONAL INFORMATION: The process in UAE starts with a classification procedure, to determine if the device should be registered or not. The information presented above is related to the classification procedure.

 

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