UAE Medical Device Registration: Requirements, Cost & Timeline

In recent years, the United Arab Emirates has become a cynosure of medical tourism, influencing the government to invest billions into the healthcare sector. For medical device manufacturers, this is a golden opportunity to set foot in a hungry market that is looking for the best technology, be it a high-tech diagnostic tool or general hospital supplies. However, before selling or distributing these medical devices, manufacturers must go through an official UAE medical device approval process to ensure they are safe, reliable, and meet quality standards.

This guide gives you a clear roadmap to understand and undergo the medical device registration process and the relevant requirements.

Defining Medical Devices in the UAE

Any product that supports medical care or health-related decisions is categorised as a medical device. This may include any instrument, equipment, software, implant, or material that is intended to diagnose diseases or medical conditions, prevent illness or injury, monitor health conditions or vital functions, treat diseases or injuries, and support or replace body functions in humans.

In the UAE, every product that is classified as a medical device must be registered with MOHAP. For example, bandages, gloves, thermometers, syringes, infusion pumps, blood pressure monitors, diagnostic equipment, surgical instruments, implants, pacemakers, and life-support systems.

Vitro Diagnostic (IVD) Devices: Explained

Vitro Diagnostic (IVD) devices are generally used to examine samples taken from the human body, such as blood, urine, or tissue, in order to diagnose or monitor medical conditions. IVD devices include blood glucose testing kits, infectious disease test kits, compounds, and analysers.

Classification of Medical Devices in the UAE

The classification of medical devices in the UAE is based on the risk they may pose to patients and users. The higher the risk, the more detailed registration requirements.

Listed are the four main classes under which the Ministry of Health and Prevention (MoHAP) and the Emirates Drug Establishment (EDE) have categorised medical devices in the UAE:

Class I (Low Risk): Non-invasive devices that have minimal contact with the body. For example, stethoscopes, manual wheelchairs, surgical bandages, and tongue depressors

Class II (Moderate Risk): Invasive for a short time and involves more complex technology. For example, ultrasonic diagnostic equipment (low-to-moderate), infusion pumps (moderate-to-high), and surgical gloves.

Class III (High Risk): Invasive or used for long-term treatment and hence require detailed technical review. For example, orthopedics implants and hemodialysis machines.

Class IV (Highest Risk/Critical): Life-sustaining or life-supporting devices that o undergoes the most intensive evaluation process. For example, pacemakers, heart valves, and neurological catheters.

Classification of IVDs: UAE medical device registration requirements

The registration process for IVD devices is also similar. However, it is classified as letters instead of numbers. For instance:

Class A: Devices with low health risk, such as laboratory reagents.

Class B: Devices with moderate or low health risk, such as pregnancy self-tests.

Class C: Devices with high or moderate health risk, such as blood glucose tests.

Class D: Devices with high health risk, such as HIV or Hepatitis screening tests.

Correct classification of devices is critical in the UAE medical device approval process to determine the type and depth of required documentation, the level of regulatory evaluation, approval timelines, and processing complexity.

Registering medical devices in the UAE: Who should register?

Medical device registration is mandatory for all businesses that are involved in bringing medical devices to the UAE market, including manufacturers, importers, distributors, and traders. 

The following entities must go through the process of registering medical devices in the UAE:

• Medical device manufacturers: Local and international manufacturers supply medical devices in the UAE market.
• Foreign companies without a legal presence in the UAE: Medical device manufacturers operating outside the UAE must appoint an authorised representative in the UAE who will manage registration, communicate with MOHAP, and handle post-market compliance.
• Distributors and importers: Businesses importing and distributing medical devices within the UAE.
• Healthcare suppliers and traders: Companies supplying devices to hospitals, clinics, pharmacies, or laboratories, or involved in starting a medical equipment trading company in Dubai.
• IVD manufacturers and suppliers: Businesses dealing in diagnostic kits, reagents, and laboratory testing devices.

Regulations governing the UAE medical device approval process

The Ministry of Health and Prevention (MOHAP) regulates, approves, registers, and monitors medical devices in the UAE at the federal level.

However, in recent years, Emirates Drug Establishment (EDE) has taken over many of MoHAP’s regulatory tasks, thus becoming the central hub for the registration and supervision of all medical products and devices.

The key responsibilities of MOHAP include:

• Approving medical devices before importing or sale in the UAE.
• Check if the devices meet international safety and quality standards.
• Supervising manufacturers, distributors, and local authorised representatives.
• Monitoring compliance throughout the life cycle of the medical product or device.

The role of the Registration and Drug Control Department (DCD) includes the following:

• Evaluation: Reviewing the technical files, clinical data, and safety certificates.
• Classification: Confirming the category of the device (Class I, II, III, or IV)
• Site Inspections: Checking if the manufacturing facility meets international Quality Management Systems.
• Issuing Medical Device Licensing: Issuing the final registration certificate for the product to enter the market.

The role of local authorities, such as the Dubai Health Authority (DHA) or the Department of Health – Abu Dhabi (DoH), is to manage the healthcare providers and facilities within their specific cities.

Registration process: UAE medical device approval process

The UAE medical device approval process was previously handled by MoHAP, which has now been taken over by the Emirates Drug Establishment (EDE) portal to facilitate faster approvals. The process includes the following steps: -

Step 1: Determine Device Classification

Identify the category of the medical device based on the associated risk level. For instance, low-risk devices (Class I), moderate-risk devices (Class II), high-risk devices (Class III), and very high-risk devices (Class IV).  By classifying the devices accurately, you can ensure adherence to the UAE medical device regulations and determine the appropriate documentation and registration pathway.

Step 2: Appoint an Authorised Representative

Foreign manufacturers that do not have a legal presence in the UAE must appoint an authorised representative to handle the process of registering medical devices in the UAE. They will act as a liaison with the MOHAP and oversee compliance with the approval process. 

Step 3: Prepare Necessary Documentation

Arrange essential documents required for the UAE medical device approval process. This may include: 

• Proof of Quality Management System (QMS) compliance, such as ISO 13485 or GMP certificates
• Approvals from the reference country
• Instructions for Use (IFU)
• Labelling and marketing materials
• Manufacturing license
• Free Sale Certificates (FSC)

Step 4: Register the Manufacturer

There are two main steps to register the manufacturer -

• Market Authorisation Holder (MAH) Registration: Submit details of the manufacturing company, including name, address, manufacturing license, and GMP/ISO certificates.
• Site Registration: Register the manufacturing site using similar details.

These steps are crucial for establishing the foundation for medical device compliance in the UAE.

Step 5: Register the Medical Device

Once the manufacturer is registered, proceed to register the medical device. Provide detailed product information and supporting documents to the Ministry of Health and Prevention. 

Step 6: MOHAP Fee Payment and Reviews

Once the submission is successful, MOHAP will review the application and documents and may request additional information or corrections, depending on the risk classification of the device and the completeness of the submission.

Step 7: Obtain Approval

Upon successful review, MOHAP will issue a registration certificate confirming the product’s compliance with medical device regulations and allowing it to enter the UAE market.

Streamline the registration process with our expertise

If the regulatory paperwork of the UAE medical device approval process feels overwhelming, it's wise to connect with an expert consultant like us, who will simplify this process with a practical approach and provide complete regulatory guidance. Our team will entirely manage the documentation, approval, and post-market compliance, so that you can focus on growing your business while staying fully compliant and on track.

For further queries or information, speak with one of our business advisors.

Disclaimer: This guide provides general information on medical device registration in the UAE. The governing regulations and procedures are subject to change. Hence, it is advisable to consult a professional healthcare consultant for definitive guidance.