Things you need to know about market access in the United Arab Emirates

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.

Manufacturer 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.

Classification

The manufacturer should understand the risk classification, prior to starting the registration process, as this affects the documentation that is needed for registration.

·        Class I – Low risk (e.g., bandages)

·        Class IIa & IIb – Medium risk (e.g., surgical gloves, infusion pumps)

·        Class III – High risk (e.g., implantable pacemakers)

·        Class IV: Critical devices (e.g., implantable devices)

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.

Device Registration

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:

1.        Appoint a local Authorized Representative

Non UAE-based manufacturers must appoint a local Authorized Representative (LAR) licensed by MOHAP. The LAR will be the contact person between the manufacturer and the competent authorities and will take care of the registration.

2.        Submission of required documentation

A summary of documentation that needs to be part of the submission package are:

a.        Manufacturer information

b.       Free Sales Certificate

c.        Labels and user manuals

d.       QMS documentation (ISO 13485 certification)

e.        Conformity Assessment documentation

3.        Review by the MOHAP

They will review the application and technical file. In some cases, additional information is requested.

4.        Registration Certificate issuance after approval

Once approved, the MOHAP will issue a registration certificate, valid for 5 years. From that moment, the device can be lawfully placed on the UAE market.

 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.

Timelines & Fees

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:

·        Medical Device Registration:

o   Application Fee: AED 100

o   Registration Fee: AED 5.000

·        Manufacturer Registration:

o   Application Fee: AED 100

o   Registration Fee: AED 10.000

·        Renewal of Registration:

o   Application Fee: AED 100

o   Renewal Fee: AED 2.500

·        Additional Costs:

o   Translation and notarization fees may apply if documentation needs to be translated into Arabic or notarized.