Medical Device Registration in the UAE

If you’re interested in bringing your next healthcare venture into the UAE, you’ll want to get clued-up on the UAE medical device registration process. First you’ll need to set your company up in the Dubai Healthcare City Free Zone or on the mainland – both of which are attractive options – before registering your medical device. In this post, we’re going to give you all the information you need on the process so you can be best positioned to make your venture a success. 

An overview of the healthcare 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 medical industry and most entities in Emirati’s pharmaceutical sector are non-Emirati firms. While MOHAP oversees the healthcare strategy and services at a federal level, some emirates have set up local health authorities, namely Sharjah (Sharjah Health Authority) and Dubai (Dubai Health Authority).

What is a medical device?

Before we go into details about medical device product registration in the UAE, we must first establish the UAE’s definition of a medical device. MOHAP classes a medical device as “any 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 fall 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 devices registration guidelines state that only the manufacturer of the medical device or their local representative can register a medical device for import and trade in the country. Applicants will require a medical warehouse licensed by MOHAP and possess a valid licence before commencing the medical device registration process.

Marketing Authorisation Holder companies must have the manufacturer’s approval and be registered by MOHAP. The local representatives may only act on the manufacturer’s behalf with prior authorisation to market the product in the Emirates. 

The documents required for the registration process will depend on the case, but you can expect to present:

• Application form of registration, signed and stamped by company

• Valid registration certificate of the factory

• Valid certificate of free sale/registration issued by authorities in the country of origin and certified by the Embassy of the UAE

• Product agency contract signed between the company and the agent

• Certificate of quality conformity/marketing authorisation, as per the classification of the equipment

• Post-marketing monitoring requirements

• Product information including description, formulation, types, sizes, models, accessories, usages, side effects, contradictions, warnings, precautions, usage guidelines, photos of packaging covers, brochures and usage manuals

• Laboratory requirements and analysis as well as pricing for certain medical devices

• One samples, certificate of analysis, external and internal covers and brochures  

• Acknowledgement of the company that equipment conforms to the specifications as per the Medical Equipment Manual (EC(European Conformity)-Declaration of Conformity)

• Safety and efficacy data 

UAE medical device registration: how to go about it

Given the intricacies of registering a medical device in the UAE, an efficient way of tackling the process is to turn to the experts. Here at Europe Emirates Group, we’re poised to help you launch your healthcare and pharmaceutical venture in the UAE, assisting in everything from forming your business to registering your medical device.

Along the way, we’ll advise you on the benefits on offer in this great economic powerhouse. So what are you waiting for? Contact us today to schedule your initial consultation. 

Written by
Adrian Oton

CEO, Europe Emirates Group