by Arti Sangar
Arti Sangar is Partner-in-Charge of the Dubai office of Diaz Reus & Targ LLP
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 tie-ups with regional institutes. This year’s Arab Health took place in January and attracted over 3000 exhibitors from 60 countries and more than 65,000 healthcare professionals from across the world.
Given the tremendous success of the event, it is expected that many foreign companies would be looking to enter into the UAE healthcare market either through distributorships and agencies or by setting up a legal entity in the country. 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 briefly sets out the main features of the regulatory guidelines for medical devices in the UAE and how it might affect medical device companies that are contemplating business in the UAE.
Ministry of Health Guidelines
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 local market, while providing the public with timely access to medical devices and preventing the entrance of unsafe devices in the market. According to the guidelines, medical device manufacturers must register their products before they can market their products in the UAE.
The Ministry of Health has worked to ensure the highest international standards in developing the criteria for medical device registration. Furthermore, the registration guidelines were designed to simulate internationally recognized rules and regulations; mainly the EU Medical Device Directive (93/42/EEC) and US Food and Drug Administration Guidelines.
Registration of Medical Device
The guidelines set out the exhaustive requirements to register medical devices. An application to register a medical device in the UAE must be made by the device manufacturer or its local representative. The local representative must be formally authorized by the manufacturer to handle the application process and the manufacturer’s legal obligations and responsibilities with regard to putting the medical device on the market in the UAE. The guidelines broadly provide four classes of medical devices for the purposes of registration. This classification system takes into account aspects such as the period of time for which the medical device is intended for use, and the degree of invasiveness on the body.
Depending on the classification of the medical device in question, and the information available with regard to approvals by regulatory bodies in other countries, the Ministry of Health considers an application for registration through either a one stage or a two stage process. The application must also be supported by the submission of objective evidence relating to the safety and effectiveness of the medical device. The registration guidelines also list the information that is necessary to be submitted in order to be considered for registration. In addition to the application, several supporting documents are required to be submitted including prior approval from recognized regulatory agencies, such as those in Europe, the US, Australia, Canada or Japan.
If the safety and effectiveness of the medical device is established and the Ministry of Health approves the registration, a certificate of registration is granted which permits the importation and sale of the registered medical device in the UAE. The registration is generally valid for 5 years.
As the key purpose of registering medical devices is to ensure safety, the guidelines also provide for post-market obligations with regard to monitoring, and preparing for, safety issues that may arise in the market place. The post-market obligations include the obligation:
a) to maintain distribution records;
b) to maintain complaint handling procedures and records;
c) to maintain adverse incident reporting procedures and records; and
d) to have procedures in place that will allow to promptly and effectively execute investigations and recalls of defective or potentially defective medical devices.
The healthcare industry in the UAE is set to boom and many foreign players would be interested to leverage opportunities offered by the UAE healthcare industry. Whether a foreign company decides to supply through a distributor or set up their own business, it can sometimes be difficult for foreign entrants to meet regulatory requirements for medical devices. Diaz, Reus & Targ LLP can assist you with all aspects of healthcare regulatory framework, particularly in respect of advice relating to registration of medical devices. For further information, please contact at firstname.lastname@example.org.