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 similar systems, mainly from the EU, USA, and Australia, the device's classification also can be divided into 3 or 4 classes: I, II(IIa,IIb), III and IV pending on the device original classification. In-Vitro Diagnostic Devices fall under Class I.

The manufacturer or its local authorized representative is required to apply for the Medical Devices Registration Committee, which will decide if the device will be exempted from further evaluation or otherwise issue the applicant an official letter requesting submission of more documents.  Our country specific (*) regulatory services in United Arab Emirates include:

Medical Device specific regulation strategy reports, Medical Device Registration with UAE MOH, UAE Representative and certification holder for Medical Device manufacturers, UAE Technical documents preparation and Arazy Group’s unique line of GlobaR - Global Regulatory Hub™ products.

GlobaR Dossier™
GlobaR - One World Process™
GlobaR Submission Center ™
Universal Authorized Representative™

Please fill the following form and submit your inquiry or discuss it with one of our online specialists. Let's get your products registered in United Arab Emirates!

(*) UAE Regulatory Affairs services are part of the diverse professional consulting services provided by Arazy Group and can be found thorough this web site and inquired on through our form or online chat services.