Medical Device Registration in the UAE

As of 2026, only companies registered in the UAE, like local authorized representative (LAR) or a local distributor, can directly apply for registration. Moreover, the mentioned entities must possess an establishment license with a registered facility.

Federal Decree-Law No. 28 of 2023 established the UAE Drug Corporation/EDE.
Federal Decree-Law No. 38 of 2024 governs medical products, pharmacists and pharmaceutical establishments.

You will need to submit the Form with proper classification, applicable CE marking/certification, US FDA clearance/approval, or other accepted regulatory evidence for medical device registration in the UAE.
You will also need to submit translations in Arabic for labels, instructions, and other related technical papers as requested by the authorities.

Although not legally mandated, the CE marking or US FDA Clearance/approval may help you get approval faster than usual, especially if you are a foreign manufacturer; the CE marking is more common and beneficial for you in case you are aiming for the UAE. Likewise, an FDA-approved device is also advantageous during the UAE registration process.

A CFS is an official document that is issued for a specific product, declaring that the product is sold and distributed in the open market of the country of origin, and must be legalized and attested.

Your medical device registration in the UAE will take around 3 to 6 months for most moderate and high-risk devices, whereas 2 to 3 months for lower-risk healthcare products. Your approval also depends on the completeness and accuracy of the application/dossier.

Your registration will be valid for 5 years from the date of the official enrollment with the Emirates Drug Establishment. If you want to continue using your registration and market access, you will have to start the renewal process at least 3 to 6 months before its expiry.

A registration basically authorizes a device for the UAE market, whereas an import license will approve specific shipments and is obtained by the local importer.

Yes, you can seamlessly register lower-risk devices more easily compared to moderate-risk and high-risk devices, given they require less documentation and scrutiny by the authorities.

In case your application is incomplete, missing data, or incorrect, then the authority will send you notices or letters, seeking clarification or rectification. Now we know it can be quite exhausting to deal with back-and-forth queries, which is where we come into the picture for professional dossier preparation and documentation.

Yes, you cannot import or distribute without the assistance of a local licensed company in the UAE. The representative already holds registration and import rights. All distribution must go through approved and compliant channels.

Once you are done with the registration, you will have to comply with post-licensing requirements like market surveillance, reporting on vigilance & adverse events, procedure for device recalls, modifications to labels, changes in packaging, reporting, and renewal of registration.

Absolutely, certain documents like an instruction manual on how to use the device, user manual, labels, packaging, and technical docs, before they are legalized and attested, get in touch with our experts and find out which documents need to be translated.

Yes, whether you are changing ownership, authorisation, representative details, product specifications, modifications, or packaging, all of this warrants a proper notification and approval from the concerned authority, like the Emirates Drug Establishment.