United Arab Emirates (UAE): Medical devices for an interesting market

The United Arab Emirates (UAE) with its hubs Dubai and Abu Dhabi is one of the most developed economies in the Middle East. The Emirates is among the wealthiest countries in the world.

The healthcare system is considered highly developed, which is why the United Arab Emirates (UAE) is a popular health tourism destination in the region. This is another reason why the United Arab Emirates is developing into an interesting market for medical device and IVD manufacturers.

1. The regulatory framework in the UAE

1.1 The regulatory authority

The authority responsible for medical devices and IVD in the United Arab Emirates is the Ministry of Health and Prevention (MOHAP).

MOHAP regulates the approval, registration, classification, and market surveillance of medical devices and IVD to ensure their safety and effectiveness.

1.2 Qualification: Definition of “medical device”

MOHAP defines medical devices as follows:

1.3 Classification

In the UAE, medical devices are divided into four risk-based categories:

• Class I: low risk
• Class IIa: low to moderate risk
• Class IIb: high to moderate risk
• Class III: high risk

Similar to the EU, classification is based on rules.

2. Approval process

The UAE offers two main pathways for the approval of medical devices:

1. Registration Pathway
2. Classification Pathway

Note: These distinctions are not explicitly set out in official guides but have been MOHAP’s practice in recent years.

2.1 Registration Pathway

The registration pathway applies to devices for home use. It is required for medical devices intended for use by lay persons or in a domestic environment.

The registration pathway involves two steps:

Step 1: Manufacturer registration

In the first step, the manufacturer registers with MOHAP as an approved facility. The manufacturer must submit its business license, company profile, ISO certification, and a list of the devices he intends to market in the UAE.

This process usually takes one to two months and costs AED 10,000 (about EUR 2,500).

Step 2: Device registration

Once the manufacturer is registered, they must register each home device individually. This process requires the submission of detailed documentation, including:

• Certificate of free sale from the country of origin
• Contract with the local agent/importer
• Proof of approvals by other supervisory authorities (e.g., FDA, CE marking)
• Documentation of post-market surveillance
• Comprehensive device information (labeling, instructions for use, marketing material)
• Product analysis documents
• Physical samples of the device

The device registration process takes three to six months, depending on the completeness of the submission and any queries MOHAP may have.

The fee for device registration is AED 5,000.

Summary

The entire approval process for a home-use device, which includes both manufacturer approval and device approval, typically takes seven to eight months and costs AED 15,000 (about EUR 4,000).

2.2 Classification Pathway

The classification pathway is a simplified procedure for medical devices intended for professional use in healthcare.

As part of the classification pathway, documents must be submitted to the MOHAP showing that the device is intended for professional use. These are usually:

• Device description and intended purpose
• Proof of professional use (e.g., technical specifications, user manual)
• Certificates or approvals from other supervisory authorities

The classification pathway is independent of the risk class and is much faster than the full registration: It usually takes about a month. At the end, you will receive a “classification letter” from the authority confirming that no registration is required for the device. This is valid for three years.

The authority’s fee for the classification is AED 500 (about USD 136).

3. Further regulatory requirements

3.1 Importers

Importers play a crucial role in the medical device market in the UAE. All manufacturers must work with an authorized importer to bring their devices to the UAE market. This applies regardless of whether the devices are subject to the registration or classification pathway.

For home-use devices to be registered, the importer must be involved in the registration pathway. The importer is responsible for submitting the application to MOHAP on behalf of the manufacturer.

For professional-use devices that follow the classification pathway, an importer is still required to import the device, but the classification application can be submitted by any entity based in the UAE, including consultants.

3.2 Distributors

MOHAP will, in the future, oblige manufacturers to designate at least two distributors in the market (“Federal Decree No. 11”).

3.3 Quality Management

Although not explicitly mentioned in the registration pathway, compliance with ISO 13485:2016 is generally expected, as is also common in other markets.

3.4 Post-Market Surveillance (PMS)

The legal framework does not yet contain any specific requirements for post-market surveillance. Nevertheless, manufacturers should be prepared to conduct post-market surveillance to ensure their devices’ continued safety and performance in the UAE market.

3.5 Proposed amendment

It is currently discussed to extend the registration requirement to all medical devices, regardless of their intended purpose.

4. Conclusion and summary

The approval process for medical devices in the United Arab Emirates is relatively uncomplicated. This applies in particular to devices for professional use.

The distinction between home- and professional-use devices has a noticeable impact on the approval process and the associated deadlines and costs.

Manufacturers should stay up to date with regulatory changes and consider working with local experts and licensed importers to navigate the registration process effectively.