The healthcare sector is one of the fastest growing sectors in the UAE, and has been identified as one of the priority investment opportunities by both the UAE government and foreign investors. Development in healthcare is not only driven by the demand of greater quality of healthcare by UAE citizens, but also by the objective of the UAE government to boost number of medical tourists visiting the UAE.
Furthermore, due to excellent logistics and transportation infrastructure, the UAE is well positioned to be the centre of medical trade in the Middle East and connect Europe and America with economies in Asia and Africa. In this article we would like to provide you with a brief overview on the legal requirements for importation and distribution of medical devices in the UAE.
1. General Overview
The distribution and importation of medical devices in the UAE is controlled by the Ministry of Health (the “Ministry”) which regulates the importation and distribution of medical devices in all Emirates. In order to be entitled to import medical devices into the UAE both the importing company and the medical device itself have to be registered with the Ministry. It is further required that the importer is either a legal entity established in the UAE or an UAE national.
Therefore, companies wishing to import and distribute their medical products to and within the UAE may either establish their own legal entity in the UAE and apply for registration of the company with the Ministry, or engage a local distributor or commercial agent who is registered with the Ministry for the importation and distribution of medical products.
2. Registration of importing company
In case a company intends to establish its own entity for the importation of medical devices, it must ensure that its trade license permits such activity. After incorporation of the entity, the company must apply for registration as a medical device importer at the Ministry of Health. The first step during the application procedure is to obtain a medical warehouse license. Such license can be obtained in case the medical warehouse meets certain minimum requirements established by the Ministry.
After approval of the medical warehouse, the company has to submit details of the medical products to be imported along with further information necessary to finalize the application.
Once the Ministry grants its initial approval, the file will be forwarded to a committee within the Ministry which will decide on a case by case basis whether the company shall be registered as approved importer of medical devices in the UAE.
3. Registration of medical devices
In addition to the registration of the company as an approved importer of medical devices, each medical product must be registered with the Ministry prior to its distribution within the UAE. In order to have a product registered, both the foreign manufacturer and the local representative have to submit an application to the Ministry for approval.
The application must contain detailed information about the medical device and its manufacturer. In our experience, the registration of medical devices already registered with governmental bodies in the European Union, United States of America, Australia, Japan or Canada is more likely to be successful as applications of medical devices manufactured and registered in other
Obtaining approval for the importation of medical devices in the UAE is similar to the application procedures in most jurisdictions. However, manufacturers not having a legal presence in the UAE
would have to engage local distributors for the importation and distribution of the products.
We are able to provide assistance and guidance throughout the necessary registration procedures and can advise on the contractual framework necessary when engaging a local distributor. For further information or assistance, please contact our colleagues at Germela-Lootah at +971-4-288-8345 or at email@example.com