Guidelines for Medical Devices in the UAE Healthcare Industry

Healthcare is among the priority sectors identified by the UAE government and as a result, the UAE healthcare industry has displayed extraordinary growth and significant progress in the past few years. In line with the UAE government's focus to improve the standard of healthcare, each year the UAE hosts the largest healthcare event in the region - the Arab Health. The Arab Health provides the perfect business platform for healthcare companies to showcase their products and enter into business relationships with health and medical institutions. This year's Arab Health took place in January and attracted over 3,000 exhibitors from 60 countries and more than 65,000 healthcare professionals worldwide.

Given the tremendous success of the event, it is expected that many foreign companies will be entering into the UAE healthcare market either through distributorships and agencies or by setting up legal entities in the region. However, prior to supplying any medical devices in the UAE, it is crucial that foreign companies register their products with the relevant authorities. This article reviews the primary features of the regulatory guidelines for medical devices in the UAE and how it might affect medical device companies that are contemplating doing business in the region.

Medical devices are regulated by the Ministry of Health which has enacted certain guidelines for the registration of medical products. The guidelines are intended to prevent unsafe or ineffective medical devices from entering the marketplace while providing the public with timely access to them. According to these guidelines, medical device manufacturers must register their products before they can market them in the UAE.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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