Medical Devices Regulatory Services In The U.A.E
What Does Medical Device Mean?
‘Medical device’ means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article (a) intended by the manufacturer to be used alone or in combination for human beings for one or more of the specific purpose(s) of diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; investigation, replacement, modification, or support of the anatomy of a physiological process; Supporting or sustaining life; Control of conception; Disinfection of medical devices; and providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body and (b) which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.
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.
Listing Of Devices
Generally, products used in hospitals under professional supervision and Class I devices do not undergo detailed evaluation. However, they are required to be listed. A Listing Certificate will be issued by the agency. After listing, the devices shall obtain import permit to market devices in the UAE.
Registration Of Devices
Our registration services include 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 subsequent devices manufactured in the same site, only device registration is required.
Device Registration
These devices are subject to review by the technical committee and upon approval will be granted a license certificate.
Process Flow
Classification
Appointing Local Representative
Manufacturing Site Registration
Technical File Compilation
Review And Approval
Device Registration
Application Submission
With an exclusive delivery center in Dubai, our company maintains an authoritative hold on the UAE Medical Device market and outlines the device classification apart from decoding the guidance regulations. We support clients with document compilation as per the standards and thus ensure quick approvals. We offer a complete range of Regulatory services pertaining to successful device marketing.
