MOHAP & EDE registration

Medical device registration in the UAE.

Medical device registration with MOHAP and the EDE follows a risk-based classification system that sets the dossier depth, the technical documentation, and the registration pathway. We handle every device class, from low-risk Class I through implantable Class III, including in-vitro diagnostics and combination products.

Device registration starts with classification, not paperwork.

The risk class of a device decides almost everything that follows: how deep the dossier goes, what technical evidence MOHAP and the EDE expect, and which registration pathway applies. Getting the class right first keeps the rest of the work on a clear track.

As a UAE-licensed entity, we can also act as your Authorised Representative, so an international manufacturer can register and stay compliant in the UAE without setting up its own local entity.

What we handle

From classification to a registered device.

A single team across classification, dossier preparation, and in-market representation.

Device classification

Classifying the device under MOHAP risk categories to set the dossier depth and registration pathway.

Manufacturer site registration

Registering the manufacturing site with MOHAP as part of establishing the device record.

Registration dossier

Preparing the device registration dossier and the technical file, with the Declaration of Conformity.

Certificate of Free Sale

Verifying and submitting the Certificate of Free Sale to support the registration application.

IFU & labelling review

Reviewing the instructions for use and labelling against UAE requirements (English and Arabic).

Authorised Representative

Acting as your Authorised Representative for the lifetime of the registration, including variations and renewals.

The path to a registered device.

Five stages, run in parallel where they can be, sequential where MOHAP and the EDE require it.

Classification

Confirm the device class and the registration pathway that follows from it.

Dossier & technical file

Compile the dossier, technical file, Declaration of Conformity, and Certificate of Free Sale.

Labelling & attestation

Review IFU and labelling (English and Arabic) and arrange embassy attestation of documents.

Submission

Submit to MOHAP and the EDE and liaise with the authority through to certificate issuance.

Maintenance

Hold the Authorised Representative role and run variations and renewals over the lifetime.

I to III

Device classes we register, from low-risk to implantable

IVD

In-vitro diagnostics handled on their specific pathway

MOHAP & EDE

The authorities your device is registered with

Accountable team across classification, dossier, and representation

Questions

Device registration, answered.

Who regulates medical devices in the UAE?

Medical devices in the UAE are regulated at federal level by the Ministry of Health and Prevention (MOHAP) together with the Emirates Drug Establishment (EDE). Devices must be registered before they can be legally imported, distributed, or sold.

How are medical devices classified for registration?

Registration follows a risk-based classification system, broadly from lower-risk Class I devices through to higher-risk implantable devices, with in-vitro diagnostics treated separately. The class determines the depth of the dossier and the documentation required.

Do foreign manufacturers need a local representative to register a device?

Yes. A manufacturer based outside the UAE registers through a UAE-licensed Authorised Representative, who holds the registration responsibilities locally. As a licensed entity, we can act as your Authorised Representative without you setting up your own local entity.

Does device labelling need to be in Arabic?

Instructions for use and labelling are reviewed against UAE requirements, which include Arabic alongside English for the relevant materials. We review and prepare the IFU and labelling as part of the registration.

Read the in-depth medical device registration guide

Bringing a device to the UAE?

Send us the manufacturer details and the device specification. We will confirm the classification, map the MOHAP and EDE registration pathway, and run the dossier end to end, acting as your Authorised Representative if you need one.

Talk to our regulatory team