United Arab Emirates Market Access for Medical Device

REGULATORY AGENCY

• Ministry of Health Drug Control Department

REGULATIONS

• Both domestic and foreign companies and their distributors/importers of medical devices must register their establishments with the Drug Control Department.
• Companies who want to export medical devices to the UAE must have a local UAE representative or distributor who holds a Medical Store license from the Ministry of Health.
• All manufacturers of Class I, Class IIa, Class IIb, Class III and Active Implantable Devices have to be registered with the UAE Ministry of Health.

GUIDELINES

• Devices shall be divided into Class I, Class II a, Class II b, Class III. The committee on medical device registration will decide to approve its registration through one or two stages.
• Registration of medical devices must be made by the device manufacturer or a local authorised representative.
• The committee will briefly review the medical device and decide if it is exempted from further evaluation or if more documents are required.
• When the medical device passes all the requirements and has obtained approval from committee, it will be granted a registration certificate which will be valid for 5 years.

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