Regulatory services UAE
The Drug Registration and Control Department (DRCD) of the Ministry of Health (officially the Ministry of Health and Prevention, MOHAP) is the government body that is responsible for regulating the importation and distribution of medical devices and IVDs in UAE.
When a manufacturer wants to export to and sell into UAE, the company that will import the products needs to be correctly established and registered with the Ministry of Health whereby its activities are correctly registered in the DED Trade License. The company importing the products must be a legal entity established in UAE or a UAE national, having a valid license as a medical store or scientific office. Next to that, the medical equipment itself needs to be registered with the Ministry of Health.
The above means that you can establish your own legal entity in UAE to import and distribute medical devices and diagnostics. You need to register an LLC company and register it with the Ministry of Health, while the activities should be correctly registered at the Department of Economic Development (DED). Both the importation of products as well as the distribution will be included in the same license. It is crucial to assure the company is correctly registered to be able to perform its tasks. Next to that, registration with the customs department is required to obtain the importation code for shipping the medical devices or diagnostics into the United Arab Emirates.
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Alternatively, one can appoint a local distributor or commercial agent that has been registered already with the Ministry of Health and is as such entitled to import and distribute medical devices and IVDs in the UAE market. The distributor or agent will be responsible to have the products registered at the Ministry of Health on behalf of the legal manufacturer and they will own the distribution rights.
If you decide to appoint a local distributor or commercial agent to do the registration on their name, it is good to mention that the local distributor or commercial agent will effectively own the rights to distribute the products within the UAE and it can be quite difficult to end this agreement in case the distributor or commercial agent are not performing as expected.
The other option is to appoint a third party as independent local representative. This company has no commercial interest, which could give the possibility to work with multiple distributors. The third party will import and store the product in their licensed medical store at a fee.
The details of both the LR and the distributor roles must be provided during device registration. If the intention is to sell directly to the hospitals or clinics, the company or importer must be registered at MOHAP as an authorized reseller of the devices while complying to the set regulations (e.g. having a warehouse space).
Classification and grouping
The medical device classification system in the UAE consists of four classes: A, B, C and D. These classes are quite similar to the EU classification: I, IIa, IIb, III. The class determines the registration procedure and requirements.
As far as IVDs are concerned, UAE aligns its classification to the European IVDR.
The registration process
The process in UAE starts with a classification procedure by MOHAP, to determine if the device should be registered or not.
A license holder, or local authorized representative, is required to start the registration procedure. Only the legal manufacturer, if it is based in the territory, or otherwise its local representative, who may act on behalf of the legal manufacturer only with prior authorization, are authorized to carry out the device registration.
Some devices do not require prior listing or approval for importation and receive an import permit at the time of importation which allows them to be marketed in UAE. Other devices need pre-approval before importation. These devices shall either be listed or registered for importation.
Registration of devices include a site registration (whereby the manufacturing site is registered in case it’s the first time a device manufactured in that specific site is being imported into UAE) and device registration (devices are being reviewed by the technical committee based on which approval will be given to import the product).
The license is valid for 5 years.
The different registration process steps are as follows:
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Appointing a local representative that is responsible to carry out the registration process;
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Classify the device or IVD;
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Manufacturing site registration (in case it’s the first device coming from that specific site);
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Compilation of the technical file;
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Submission of application;
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Review and device registration.
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Local testing
Local testing is not required. All manufacturers should register their manufacturing facility as part of the device registration process. Manufacturers of class III or IV devices may be subject to an onsite audit and inspection.
Labelling
Labelling and documentation should be provided in English.
Time-to-market
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The MOH normally takes around 1 month for product classification.
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Registering the manufacturer site takes 1 month.
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Product registration takes around 2 months (provided the required documents have been legalized).
In reality, review times can be longer dependent on additional questions asked. The validity of the MDMA is five years and application renewal can be submitted 3 months prior to the expiry of the license. During the three years updates on already approved devices can be submitted. Post-marketing surveillance reports are required for high-risk devices as defined by the DRCD.
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