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. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including UAE, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in UAE

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.

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