The importation of medical devices into any of the emirates of the UAE is controlled by the Ministry of Health. In order to import medical devices into the UAE, the importing company must be an individual or entity established in the UAE and licensed to import medical products into the UAE. With regard to an individual, only UAE nationals may apply in their individual capacity to be a registered importer of medical devices. While in the past only companies entirely owned by UAE nationals could apply for a license to import medical products, currently companies owned by both a UAE shareholder and a foreign shareholder may also apply for such a license.
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Importation of Registered Medical Devices
Under federal law, no medical device may be put into circulation except after registration of the product with the Ministry. Thus, even if a company is licensed to import medical products, it will not be permitted to import a medical device or pharmaceutical unless that specific product is registered with the Ministry. In order to register a medical device or pharmaceutical with the Ministry, an application for a medical device or new drug application, as appropriate, must be submitted to the Ministry for review and approval. The application must be made by the manufacturer from the country of origin (the market authorization holder in case of pharmaceutical products) jointly with the local authorized representative. The local authorized representative must be explicitly designated by the foreign manufacturer to act in the UAE, on behalf of the manufacturer, with regard to the manufacturer’s legal obligations and responsibilities. The Ministry will accept the accreditation of conformity assessment bodies from the European Union, Australia, Canada, the United States of America, Japan and Singapore, and will also consider any approval obtained for a product from other competent authorities.
Importation of Unregistered Medical Devices
There is an exception to the general position under Federal law, which provides specific approvals for the importation of an unregistered medical product. The intention behind the exception is to allow for emergency medicines or medical devices to treat rare conditions, which may not be registered due to the cost-prohibitive nature of registration. This system allows providers and patients to access treatments despite the lack of registration.
The importation of an unregistered medical product must be performed in conjunction with a hospital or clinic local purchase order and a justification letter from a medical consultant. The letter should include the clinical reasons for using an unregistered medical device instead of a registered alternative. Even so, the importation of unregistered medical devices is still permitted only by a licensed UAE medical store. In order to obtain Ministry approval for the importation of an unregistered medical device, as a minimum, the following documents are required:
- Ministry license of the importer
- Valid trade license
- Local purchase order from the hospital or clinic
- Declaration letter from the hospital or clinic
- Justification letter from the medical consultant.
Warehouse License Registration
According to the UAE Pharmacy Law, the first step in order to import medical devices within the UAE is to obtain a license for a warehouse in the country, as mentioned under Article 47 of the Law. Ministry of Health and Prevention (MOHAP) has laid down certain prerequisites for specific conditions of the warehouse including the size, location, storage of pharmaceuticals and devices, and appointment of a licensed pharmacist who will oversee the goods being imported.
Upon receiving the license application for the warehouse, the MOHAP will inspect the place in order to ensure that the warehouse meets the requirements set out by the law and the guidelines laid down by the competent authority. The license will be granted to the facility if the MOH is satisfied with the warehouse. The Ministry offers a service where they inspect the warehouse prior to the lease agreement being signed as this will allow the company to wait and understand if the Ministry approves the warehouse.
Once the inspection is completed, and the entity has received MOHAP approval, the next step for the company is to submit a file along with all relevant supporting documents including, proof of inspection, details pertaining to the licensed pharmacist, and information about the categories of pharmaceuticals and medicals devices that will be imported by the company. Ministry will review the concerned file and holds the sole discretion to accept or reject the application. If accepted, the file will be transferred to the final committee of Ministry. The foregoing Committee reviews the file and all other applications and determines which companies must be given license for a warehouse for importing pharmaceuticals and medical devices.
Different Alternatives Available to Import Medical Devices
There are two alternatives available wherein the desired can import, sell and market medical devices and drugs within UAE. These alternatives are as follows:
- Incorporate a company: companies who are willing to import medical devices and drugs within UAE can establish a mainland company with a UAE national shareholder holding 51% of the shareholding. The companies should, at all times, ensure that the trade license and permits to perform such activities are in place and should be associated with the importation of pharmaceutical products. It is pertinent to note that the activities undertaken by the company should be properly highlighted on the trade license. Otherwise, the company will not be allowed to perform such activity;
- Enter into an agreement with the distributor or agent: the companies who are not willing to establish their presence can sign an agency agreement with the local agent and register the pharmaceuticals and devices within the country. The agent will act on the behalf of the company to import, distribute and market the pharmacy products.
Unless the medical product has been specifically ordered by a hospital or clinic and approved as a permissible unregistered medicine by the Ministry, it also is necessary for the medical product itself to be registered with the Ministry. While registration of a medical device takes longer than the registration of a company, it can be done simultaneously. We, at PRD, are here to provide guidance on each element of bringing a medical device to market in the UAE, from establishing a local entity and providing contract drafting and review, to registering the medical products. You can Contact Us via our WhatsApp # 971 54 582 1012 or send an email at info@productregistrationdubai.com.
