Medical Device Registration in United Arab Emirates
Regulatory authority: Medical devices in UAE are supervised by the Drug Control Department of the Ministry of Health and are subject to the UAE Medical Devices Registration Guideline. The UAE regulatory system simulates systems from the EU, USA, and Australia.
Classification: The classification of devices can be divided into three or four classes: I, II (IIa, IIb), III, and IV, depending on the device’s original classification. In-vitro diagnostic devices have a classification system of their own that is dependent on risk and original classification.
The manufacturer or the local authorized representative submits an application to the Medical Devices Registration Committee, which will decide if the device will be exempt from further evaluation, or officially request the submission of further documentation.
Timeframe of registration: Medical devices are registered in UAE within a timeframe of nine months.
Length of license: Licenses issued in UAE expire when either the CE mark expires, or after three years.
It is possible to obtain an import permit for a shipment; this procedure takes 1-2 months.
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