Registering a medical device in the UAE starts with one question that shapes everything else: what is your device's risk class? Classification determines the documents you need, the depth of clinical evidence, and the route your file takes. Here's how device registration and classification work in the UAE in 2026.
Who regulates medical devices in the UAE now
As with medicines, oversight is moving. The Emirates Drug Establishment (EDE), established under Federal Decree-Law No. 38 of 2024, is now the UAE's federal authority for medical products and has been taking over device registration services previously handled by the Ministry of Health and Prevention (MOHAP). Manufacturers should confirm the current submission route before starting a file.
The UAE classification system
The UAE follows a risk-based classification aligned with the international Global Harmonization Task Force (GHTF) framework. A device's class is determined by its intended use, duration of contact with the body, and degree of invasiveness. There are four device classes:
| Class | Risk level | Examples |
|---|---|---|
| Class I | Low | Non-invasive items such as bandages or stethoscopes |
| Class II | Moderate | Diagnostic instruments and many reusable devices |
| Class III | High | Life-supporting devices requiring substantial clinical data |
| Class IV | Very high | Implantable and life-sustaining devices |
In vitro diagnostic (IVD) devices use a separate four-tier scale, Class A (low risk) through Class D (high risk), reflecting the public-health impact of an incorrect result.
If you are unsure where your device sits, you can request an official classification letter from the EDE. Getting classification certainty early prevents the most expensive mistake in device registration: building the wrong dossier.
The registration process
Set up your UAE Authorised Representative
A foreign manufacturer registers through a UAE-licensed Authorised Representative, which holds the registration and acts as the point of regulatory accountability, including for post-market surveillance once the device is on the market. This lets you reach the market without setting up your own UAE entity. The AR registers and manages the device on your behalf, but ownership of the registration stays with you, the manufacturer, and can be moved to a different AR at any time.
Site and device registration
Registration generally proceeds from establishment/site registration to the device registration itself, with the documentation scaled to the device's risk class.
Maintain compliance after approval
Higher-risk devices carry ongoing obligations, such as periodic safety reporting. Planning for the full lifecycle, not just the initial approval, keeps a device compliant and on the market.
Documents you'll typically need
- ISO 13485 quality management system (QMS) certification
- Proof of approval in the country of origin (e.g. CE marking or US FDA clearance)
- Device technical documentation and labelling
- Clinical or performance data, scaled to the risk class (more for Class III/IV)
- Bilingual English and Arabic labelling and Instructions for Use (IFU)
- Appointment documents for the UAE Authorised Representative
Frequently asked questions
How are medical devices classified in the UAE?
Who regulates medical devices in the UAE in 2026?
Do I need a local representative to register a device?
What documents are required?
How do I confirm my device's classification?
This guide is general information, not regulatory or legal advice. UAE requirements are actively changing during the MOHAP to EDE transition; confirm current rules with the relevant authority or your regulatory partner before acting. Related: medical device registration services.