Medical Device Registration in UAE

The healthcare market in the UAE is on course for rapid expansion thanks to government spend, the maturation of the private market, and demands from users for quality health care services. This has now positioned the UAE as a valuable entry point into the Middle East (ME) and Gulf Cooperation Council (GCC) region for international medical device market entrants. 

As with any market, there are several barriers to entry, and sustaining presence in this market is not without challenges, which, for the most part, are associated with the Ministry of Health and Prevention (MOHAP) requirements and procedures for registration and regulation of a medical device. The main focus of this article will be to provide you with a high level overview of the medical device registration in UAE, and those steps, and how Herms Global can assist you in managing and streamlining that role.

Why Do You Need Medical Device Registration in UAE?

Before a medical device can be sold, provided, or advertised in the UAE, it requires MOHAP registration to confirm that the firm meets the safety, quality, and performance regulations for the listed products by international standards. 

Some of the significant advantages of medical device registration in UAE are: 

• - Legal access to the market in a high-growth part of the world 

• - Improved credibility and brand awareness 

• - Immediate access to other opportunities through public and private health agencies 

• - Legal access to customs clearance and import approvals. 

• If you sell a medical device without registering the device in the UAE, you will be in regulatory violation of selling without registration which could result in considerable penalties, later confiscation of the product or even banning you from marketing it again.

Who Regulates Medical Devices in the UAE? 

The main regulator of medical device registration in UAE, which is responsible for classification, registration, and import, is the Ministry of Health and Prevention (MOHAP). Foreign manufacturers can apply for registration if the manufacturer has a Local Authorized Representative (LAR), and the registration will only be handled and submitted by an entity or person located in the UAE. Herms Global acts as your LAR and facilitates the engagement with MOHAP with full regulatory scope, on behalf of your organization.

Essential Requirements for Medical Device Registration in UAE

To register your medical device successfully with MOHAP, you will need the following:

1. Local Authorised Representative (LAR) - You must appoint in the UAE a licensed entity with MOHAP that can submit your registration on your behalf. Herms Global offers the total LAR service to provide you clarity in communication and process submissions promptly.

2. Free Sale Certificate (FSC) - Certifying that the device is for sale in the country of origin from the regulatory authority.

3. International Approvals (CE/FDA/Other) - Devices with CE Marking, FDA Approval, or valid authority recognition from reputable global regulators will make registration easier and quicker.

4. Technical Documentation / Dossier - All relevant technical files must be compiled which can include:

Product description(s) and intended use(s)

• Description of the design, manufacture and/or production process. 

• Clinical evaluation reports prepared domestically and abroad.

• Risk Analysis and Mitigation.

• Instructions for Use (IFU)

• Labelling samples in English and Arabic.

5. Labelling Requirements - Labels must meet MOHAP standards and should include: 

Device name

• Manufacturer, LAR and/or Distributor

• Expiry or manufacturing date 

• Storage conditions 

• Instructions for safe use 

6. Distribution Agreement - Submission will require the submission of a signed contract between the LAR or distributor and the manufacturer. 

Common Mistakes Made

The registration process is not particularly complicated but avoiding some common mistakes will mitigate delays/denials:

• Incomplete or out-of-date technical files submitted

• Unlicensed or inexperienced LAR 

• Failing to consider Arabic labelling requirements

• Misclassifying the device

• Not receiving updated regulatory changes from MOHAP

• Avoiding the issues above can save time, money and market entry.

How Herms Global can assist with the process?

Herms Global specializes in regulatory affairs and market access services for the Gulf Cooperation Council Group. Below is how we can support you:

• Act as your Local Authorised Representative

• Prepare and audit all documents

• Coordinate with MOHAP directly, and submit

• Design Arabic translations and ensure labels comply

• Manage renewals, post-market surveillance, & updates 

• End-to-end service for your product until it is registered and imported 

We have assisted global organisations in medical device registration in UAE quickly with confidence and compliance.

Ready to Register in the UAE?

Navigating the regulations in the UAE takes skills, patience, and must have proactive ways. Herms Global has a stress-free, fully managed service for  Medical Device Registration in UAE for medical device manufacturers wanting to enter the UAE market.

Herms Global - Your Compliance, Our Commitment.