UAE Medical Device Registration Consultants (MOHAP / EDE)

UAE medical device registration is required before devices and IVDs can be imported and sold at federal level in the United Arab Emirates. Federal registration services previously run by the Ministry of Health and Prevention (MOHAP) have moved to the Emirates Drug Establishment (EDE). Medfins International helps manufacturers prepare dossiers, work with their UAE representative and navigate the new EDE procedures.

What is UAE medical device registration?

UAE medical device registration is the federal marketing authorisation that allows a medical device or IVD to be imported, stored and supplied in the country. For many years this was handled by the Ministry of Health and Prevention (MOHAP). As part of a wider reform of medical product regulation, the UAE created the Emirates Drug Establishment (EDE) as the federal regulator for medicines and medical products.

MOHAP has announced the transfer of selected regulatory services to EDE, including registration and renewal of registration of medical equipment and the licensing of medical product manufacturers, medical warehouses and stores. In practice, new applications, renewals and variations are now handled through EDE channels, while some legacy MOHAP references and portals may still appear during the changeover.

A note on the transition

Procedures, portal links and document checklists have been evolving since the transfer began. Before each submission we confirm the current requirements directly with the authority and through your UAE representative, rather than relying on older MOHAP guidance.

Who needs UAE medical device registration?

• Foreign manufacturers, including Indian exporters, who want their products distributed in the UAE.
• Local manufacturers producing medical devices in a UAE-licensed facility.
• UAE importers and distributors acting as the local representative or marketing authorisation holder, who must hold an appropriate pharmaceutical or medical establishment licence.

Foreign manufacturers cannot apply directly. They work through a UAE-licensed local representative (often the distributor or a scientific office) that submits applications, holds the registration and manages post-market obligations. Choosing this partner carefully matters, because it affects who controls your registration.

Classification and scope

The UAE applies a risk-based classification broadly aligned with international (GHTF/IMDRF) practice and with EU rules, with general medical devices grouped into low, medium and high-risk classes and IVDs classified separately. The class determines the depth of review and the documents requested. Where classification is unclear, the authority can be asked for a determination.

Registration is generally product-specific, and a manufacturer or site may also need to be registered or listed before its products are accepted. Drug-device combinations and borderline products may follow a different route, so they should be assessed early.

Documents typically required

• Authorisation letter or agreement appointing the UAE local representative, legalised as required.
• Certificate of Free Sale from the country of origin, with legalisation or attestation.
• Reference market approvals such as CE certificates, US FDA clearance or other recognised approvals.
• ISO 13485:2016 certificate and Declaration of Conformity.
• Technical file or summary technical documentation: device description, intended use, risk management, verification and validation, and clinical or performance evidence.
• Labelling and IFU meeting UAE requirements, including Arabic content where needed.
• Stability or shelf-life data, sterilisation validation and product samples or images where requested.

Registration process: step by step

1. Market and classification assessment to confirm scope, class and likely route.
2. Local representative appointment with a UAE-licensed establishment and a clear written agreement.
3. Manufacturer or site registration where required by the authority.
4. Dossier preparation: gathering and legalising certificates, compiling technical documents and labelling.
5. Online submission through the current EDE e-service channel by the local representative.
6. Review and queries: responding to technical or administrative requests.
7. Registration certificate issued, followed by pricing where applicable and import permits for shipments.
8. Post-market obligations: vigilance, field safety notices, variations and timely renewal.

Renewals, variations and changes of representative

A UAE registration is valid for a defined period and must be renewed before expiry to avoid interruption of imports. Changes to the device, such as new models, materials, labelling, manufacturing site or legal manufacturer name, usually require a variation to be notified or approved before the changed product is shipped.

If you change your UAE distributor, the registration may need to be transferred or a new application filed, depending on who holds it and on current EDE rules. Building these scenarios into your distribution agreement from the start avoids supply gaps later.

Timelines and what affects them

Review times vary with the device class, the strength of reference approvals and the completeness of the dossier. Legalisation of certificates in the country of origin and UAE embassy attestation often take longer than the technical preparation, so plan for them early. The ongoing MOHAP-to-EDE transition can also add administrative steps.

Common reasons for delays and queries

• Certificates of Free Sale or authorisation letters that are expired, unlegalised or inconsistent with product names.
• Model lists and product codes that differ between CE certificates, labels and the application.
• Labelling or IFU not meeting local language or content expectations.
• Using outdated MOHAP forms or checklists after services moved to EDE.
• Unclear local representative arrangements or disputes over who holds the registration.

How Medfins International supports you

We assess your products for the UAE, prepare and review the technical dossier, coordinate certificate legalisation and work alongside your UAE local representative through submission and queries. For manufacturers without CE marking or FDA clearance, we can build that reference approval first through our CE marking or US FDA 510(k) services.

If you are planning wider Gulf access, the same dossier can often be adapted for Saudi SFDA registration. Contact us to plan your UAE entry.

Frequently asked questions