How to Get Medical Device Registration in Dubai

The healthcare sector in Dubai is expanding at an amazing speed, leading to a need for new and trustworthy medical devices. Any medical devices, such as diagnostic tools, surgical equipment, or health monitors for wearables, are crucial to patient care improvement. However, it should be noted that before any such device can be sold in the UAE, it has to be registered with the Ministry of Health and Prevention (MOHAP) officially. The process mostly includes regulatory agreements, technical documents, and full compliance with local regulations. Therefore, it is of great importance that manufacturers and importers are fully aware of the entire approval process.

This blog will give you all the steps on how to get your medical devices registered in Dubai.   

What is a Medical Device?

A medical device is any item, instrument, machine, or product that is intended for use in the diagnosis, treatment, or prevention of diseases and medical conditions. Such devices are instrumental in healthcare professionals’ work, but are not based on chemical or biological principles as medicines are.

Medical devices can be very simple, e.g. bandages and thermometers, or more complicated, e.g. X-ray machines, surgical instruments, and heart monitors. In Dubai, all medical devices must be registered with the Ministry of Health and Prevention (MOHAP) before they can be sold or used to make sure they are safe and meet quality standards.

Categories of Medical Devices

Medical devices are classified into various categories according to the degree of danger they may cause to patients and users. The classification serves as a guide for the authorities to determine the procedure and extent of the safety tests required for each device prior to its approval.

The UAE categorizes medical devices into four risk-based categories.

• Class I (Low Risk): They are made of very simple materials, and they include bandages, thermometers, and surgical gloves. The operation of such devices is very easy, and the risk is minimal.
• Class IIa (Low to Medium Risk): Some of such devices are dental instruments, syringes, and diagnostic ultrasound equipment. To be more precise, they need more oversight than Class I.
• Class IIb (Medium to High Risk): The examples can be ventilators and anesthesia machines. They are more complicated, and they are also used in the medical field for more severe cases.
• Class III (High Risk): These devices include pacemakers, heart valves, and implantable defibrillators. They are used for life-supporting or life-sustaining purposes and must meet strict regulatory standards.

Step-by-Step Process for Medical Device Registration

The UAE’s Ministry of Health and Prevention (MOHAP) is the regulatory authority that ensures that medical devices sold in Dubai are registered. The objective is to confirm that the devices are safe, efficient, and of good quality, and that only those products are allowed in the UAE market.

First of all, an applicant must check that the device they want to register is allowed by MOHAP. If it is, then they

1. Appoint a Local Authorized Representative (LAR)

Foreign companies that want to trade in the UAE can only do so through a Local Authorized Representative (LAR). The LAR must be an enterprise that is licensed to import and distribute medical devices and that will manage all communications with MOHAP regarding the manufacturer’s activities.

2. Obtain a Medical Device Importer License

Before signing the product in the product registration system, the LAR must obtain an Importer License from MOHAP, which is still valid. This license is a confirmation that the company is going to import medical devices into the UAE and that they meet the requirements of the regulations.

3. Collect All Required Documents

A complete set of documents must be gathered, including:

• Free Sale Certificate legalized by the UAE embassy in the country of origin
• ISO 13485 certification
• CE marking or FDA approval
• Product labels and packaging information
• Clinical evaluation reports
• Instructions for Use (IFU)

These documents prove the product’s safety, quality, and regulatory compliance.

4. Device Classification and Risk Assessment

Identify the medical device’s accurate class (I, IIa, IIb, or III) by the means by which it is intended and the degree of danger. MOHAP will also examine this classification during the assessment process.

5. Submit the Registration Application to MOHAP

The LAR submits the online registration application via the MOHAP e-services portal. This is also the stage where the complete information and product details are provided. Along with the application, the payment of the application fee is required.

6. MOHAP Technical Review and Evaluation

MOHAP will perform a comprehensive technical evaluation of the application. The scope of this evaluation also covers the product’s intended use, the risk associated with it, the quality certificates, and compliance with the UAE laws.

7. Feedback and Corrections (if any)

In case MOHAP finds some documents missing or if they need clarification, they will inform the LAR. To proceed with the assessment, verification, or the provision of further particulars must be done without delay.

8. Approval and Issuance of Registration Certificate

After fulfilling all the criteria, MOHAP will grant a Medical Device Registration Certificate. The certificate is valid for five years and authorizes the product to be retailed and marketed legally in the UAE.

Role of SetupMate in Assisting with Medical Device Registration in Dubai

SetupMate is one of the main factors in facilitating business registration of medical devices in Dubai by providing full assistance to businesses in the whole process. SetupMate not only makes sure every step is correctly done but also helps businesses get acquainted with MOHAP regulations, find the right device classification, and prepare necessary documents. They also help with appointing a Local Authorized Representative or coordinating with one, submitting applications online via the MOHAP portal, and answering any queries from authorities. 

Their competence not only helps to avoid postponement and minimize the chance of mistakes, but also provides a smooth and efficient registration experience. Businesses can rely on SetupMate when they need to go through the process of bringing their medical devices to the UAE market while being fully compliant with local laws.