In the United Arab Emirates (UAE), medical devices are regulated by the Ministry of Health and Prevention (MOHAP). They evaluate the safety and quality of the devices in line with international standards such as U.S. FDA and European CE.
For medical device manufacturers, the UAE is a very interesting market to consider, since it is rapidly growing, has high standards of healthcare and there is a rising demand for advanced medical technology. Also, devices already approved in the US, EU, Canada, Australia, or Japan may benefit from a simplified registration process.
Before you can start to sell or distribute your medical device in the UAE, it must be registered with MOHAP. To ensure patient safety, the UAE has set strict rules for registering these devices.
There are 3 steps in this process: Manufacturer Registration, Classification of your device according to UAE regulations and Device Registration.
All manufacturers, including those based outside the UAE, must register their manufacturing facility with MOHAP before submitting any device registration applications. This step is mandatory and requires the submission of applicable facility documentation and certifications.
The manufacturer should understand the risk classification, prior to starting the registration process, as this affects the documentation that is needed for registration.
Low risk classes may require less documentation, where higher risk classes must need clinical data and safety reports. Also, to determine the timelines for placing your devices on the UAE market, it is good to understand that the review time for higher risk classes may take longer then for lower risk classes.
There are different registration routes to enter the UAE market. MOHAP Registration Route is the most common route and the steps to take for this route are explained later in this blog. This route is applicable to all medical devices, IVDs, and combination products.
Devices that are only sold or distributed in free zones and not in the mainland of UAE can take the Free Zone Registration (For Free Zone Sales Only) pathway. In this case, no MOHAP registration is needed if the device stays within the free zone. These devices can be used for demonstration, exhibition, or evaluation purposes within the zone. Devices under this route cannot be marketed or sold in the mainland UAE.
For temporary or limited-use purposes, such as clinical trials or research purposes, the Temporary Import Permit (Special Permit Route) is available. Key features are that these devices do not require full registration, but they do require MOHAP approval on a case-by-case basis.
In specific cases there is also Registration via Dubai Health Authority (DHA) or Other Emirates. Although MOHAP is the primary regulator, some local health authorities like DHA (Dubai) or DoH (Abu Dhabi) may have additional requirements for device usage within their healthcare facilities. This registration is typically applicable for tenders or device use in government hospitals and may require separate registration or listing with these bodies in addition to MOHAP registration.
Going back to the pathway that is most common for UAE: MOHAP Registration Route. To register medical devices in the UAE, the following steps need to be taken:
It must be noted that the registration process holds a 2 step approach for manufactures that are going to sell their devices on the UAE market for the first time. The site registration is the first step, then the device registration follows afterwards. Bear in mind that these are two consecutive processes, these can’t be performed in parallel.
MOHAP Device Registration review typically takes around 4 to 6 weeks for Class I and Class II medical devices. For Class III and Class IV devices, which often require more comprehensive clinical data, the review process may extend to 8 to 10 weeks. The Manufacturer Registration takes 1-2 months.
Ministry of Health and Prevention (MOHAP) fees to consider: