United Arab Emirates
General country-specific regulatory information is provided on this page. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, free of charge, to expedite the preparation of your medical device or IVD registration application.

REGULATORY AUTHORITY:
Medical devices are regulated by the Drug Control Department of the Ministry of Health (MOH).  

CLASSIFICATION SYSTEM: Medical devices are classified according to the EU risk-based model into Classes I, IIa, IIb, III, and IV.

TIMEFRAME: It takes approximately nine months to receive approval in the UAE.

LICENSE VALIDITY: Licenses issued in the UAE are valid for five years.

AUTHORIZED REPRESENTATIVE: An authorized representative is required to register medical devices in the UAE.

Last updated on January 29 2015.



Interested in obtaining fast market approval for your medical device or IVD in the UAE? REQUEST A FREE QUOTE>

For more information on registration in the UAE, check out the following articles on our blog:
Country at a Glance: United Arab Emirates
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