Medical Device Registration in the UAE
Are you interested in bringing your next healthcare venture into the UAE? The medical device registration process involves some critical requirements to satisfy. Whether you choose to establish yourself in the Dubai Healthcare City Free Zone or on the mainland, the medical device industry in Dubai or any of the other emirates is appealing. We have what you need to enter this industry segment while taking advantage of the benefits stemming from the UAE’s business-friendly environment.
But first, a brief overview of the Ministry of Health and the pharmaceutical sector in the UAE
The United Arab Emirates’ Ministry of Health and Prevention (MOHAP) is the government authority in charge of medical device registration, as well as regulations for other medical products, including prescription and over-the-counter pharmaceutical products. There are no private entities that regulate any medical products in the Emirati pharma industry, and most entities in Emirati’s pharmaceutical sector are non-Emirati firms. MOHAP oversees the healthcare strategy and services for all of the northern Emirates, while other organisations in Sharjah, Abu Dhabi and Dubai that manage medical services and facilities in those emirates.
What is a medical device?
Before going into the intricate details about this process, we need a firm understanding of what the UAE defines as medical devices. What is considered a medical device? MOHAP classifies a medical device as “[a]ny instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article.” The medical device’s intended use must qualify under several permitted uses that include diagnosing, mitigating or treating illnesses or injuries. It also covers anything examining, reporting, supporting or replacing life systems or a life-supporting procedure, as well as controlling the origin or sanitising of these devices. Finally, it covers all devices intended for in-vitro examination of any body part.
The medical device registration process
The UAE medical device registration regulations dictate that the only entities allowed to carry out medical device registration are the manufacturer of the medical device or their local representative. The UAE medical devices Registration Guidelines require a drug warehouse to register with MOHAP and possess a valid licence before commencing the process to register their devices for import and trade in the country. As for Marketing Authorisation Holder companies, they must also have the approval of the manufacturer and with MOHAP. The local representatives may only act on the manufacturer’s behalf with prior authorisation to market the product in the Emirates.
Before you start any part of this medical device or establishment registration, you must complete registration with MOHAP. After that, as part of your application, it will fall under one of four classes. The classification is crucial because that will determine what documents you must present. What are the criteria that MOHAP examines when looking at medical devices to authorise in the UAE? They may consider how invasive it will be to an organism, how long the treatment will last, among other factors. Then, based on the class of the product, the Committee at the Drug Control Department that makes the final decision may request more corroborating details about the medical device’s efficacy.
While the final list of documents to include with the application form ultimately depends on the class, you may have to present the following:
- Valid registration certificate for the factory building the device
- Copy of the product agency agreement that the manufacturer and agent signed
- Valid free sale/registration certificate issued by the pertinent authorities in the country of origin legalised at the Emirati embassy
- Requirements for monitoring after marketing the product
- Quality conformity/marketing authorisation certificate depending on whether the device falls under Class I, II, III or IV
- Copies of the product registration certificate from other countries as applicable
- Product information covering all specifications
- Peer-reviewed literature discussing the efficacy of the equipment and analysis from the laboratory
For biomedical companies looking to enter the UAE market, challenges can result if the country of origin does not require regulatory approval for the activity. In that case, since the country of origin does not have any way of providing that documentation, foreign applicants should pay close attention to these requirements coming from the UAE Ministry of Health.
Are you looking to go through the medical device registration process in the UAE?
The intricate legal framework proves the value of working with UAE company formation experts when dealing with medical devices in Dubai or any other part of the UAE. Whether you choose to pursue the Free Zone model at the Dubai Healthcare City Free Zone or anywhere on the mainland, our team is ready to help you be part of the healthcare and pharmaceutical innovations taking place in the UAE. We will also guide on understanding the advantages stemming from this low-tax, flexible business jurisdiction. Would you like to get started? Schedule your initial consultation.
CEO, Europe Emirates Group