Medical Device Certification Services

Regulatory Authority: Drug Control Department of the Ministry of Health (DCD/MOH)
Regulation: UAE Medical Devices Registration Guideline
Regulatory Pathway: Product Registration
Authorized Representative: Required
Validity of License: 5 Years
Language: English

UAE Medical Device Classification

UAE has separate Classification Rules for Medical Devices and IVDs. The classification rules are in line with the classification rules of the EU Medical Device Directives. The class of devices as per the UAE classification rules are as below

UAE Local Representative

Foreign Manufacturers, with no physical office shall appoint a Local Representative (LR) to act on behalf of them. The local representative should be licensed by the Ministry of Health as a medical store or scientific office (in case of scientific office, importation and distribution activities should be performed by an appointed Licensed Medical Store). The applicants may appoint their distributor as their Local Representative. However, having an independent Local Representative, with no commercial interest, would provide required flexibility to appoint multiple distributors in the UAE. The details of both the LR and the distributor must be provided during device registration.

UAE Medical Device Registration

Certain Devices do not require prior listing or approval for importation and such devices will be regulated at the time of importation. Such products exempted from registration or listing shall apply and obtain an Import permit to be marketed in UAE. For other devices, imports will not be cleared unless a pre-approval for importation of the consignment is issued by the DRCD. Such devices shall either be listed or registered to import into the UAE

Listing of Devices

Generally, products used in hospitals under the professional supervision and Class I devices do not undergo detailed evaluation and they are required to be listed. A Listing Certificate will be issued by the agency. The devices after listing shall obtain import permit to market devices in the UAE.

Registration of Devices

The Registration activity includes Site and Product Registration.
Site Registration : The manufacturing site must be registered, if the device manufactured in that Site is being imported to the UAE for the first time. For the subsequent devices manufactured in the same site, only device registration would suffice, and site registration is not required.
Device Registration : These devices are subject to review by the technical committee which upon approval will be granted a license certificate.