Medical device registration in the UAE: what clinic operators need to know

The Emirates Drug Establishment (EDE) was created by Federal Decree-Law No. 28 of 2023. Federal Decree-Law No. 38 of 2024 on medical products, the pharmacy profession and pharmaceutical establishments came into force on 2 January 2025. It covers medical devices as medical products, and its Article 5 says no medical product may be imported, distributed, sold or used in the UAE until it has an EDE marketing authorization.

The federal health regulator transferred selected services to EDE from 29 December 2025. The list includes all types of marketing authorizations for medical products, registration and renewal of registration of medical equipment, registration of manufacturers of medical products, product classification, permits to import medical equipment, and licensing of medical warehouses, medical stores, marketing offices and factories. In a statement dated 5 January 2026, the regulator said 44 services moved to EDE in full and 13 in part. Community and compounding pharmacies stay with the federal health regulator, as do five narcotic-drug services: controlled-medicine prescription books, narcotic custody authorization for hospitals, narcotic quotas, and narcotic approvals for in-house pharmacies of private hospitals and for day-surgery centres. Medical device registration is not among them.

You apply on ede.gov.ae with UAE PASS and pay fees electronically. EDE's toll-free number is 800 33784 and its email is [email protected].

EDE's device marketing authorization service sorts devices into four classes, Class I to Class IV, and asks for evidence that matches the class: a quality conformity or marketing authorization certificate such as a CE certificate, an FDA 510(k) or an FDA PMA, plus safety and efficacy data for Class III and Class IV devices. The service page does not publish the rules for assigning a class.

If you are not sure whether a product is a medical device, or which category it falls in, EDE's Classification of a Medical Product service answers the question. The fee is AED 500 and the published service time is 10 working days. You send the product catalogue, a picture, a certificate from the authority in the country of origin (for example a free sale, ISO or CE certificate), the leaflet in English or Arabic, and the label artwork. The classification letter states which UAE laws govern the product and its regulatory category, and that category decides whether an EDE marketing authorization is needed. If it is, the product must be registered in the category the letter states. EDE does not state how long the letter stays valid.

For a product whose status is unclear, get the classification letter before you sign the purchase order.

Registration runs in two stages.

First, the manufacturer is registered. EDE's Registration of a Manufacturer of Medical Products service costs AED 100 plus AED 10,000, has a published service time of 2 to 4 weeks, and must be renewed every five years. A medical device manufacturing site sends a notarized authorization letter naming the person or local establishment that will submit the file, a valid legalized ISO 13485 certificate, a legalized business or manufacturing licence from the country of origin attested by a UAE Embassy, a list of the products made or assembled at the site, a company profile, a site master file, and copies of its registrations in other countries. The site's marketing authorization holder, which is the legal manufacturer, must also be registered with EDE, and its documents can go in with the site application.

Second, each device gets a marketing authorization. EDE's Issuance of Marketing Authorization for a Medical Device service costs AED 100 plus AED 5,000, and the published completion time is 45 working days. The applicant must be a medical warehouse or marketing office with a valid EDE licence. The file includes the signed application form, the factory registration certificate, a valid free sale or registration certificate from the country of origin certified by the UAE Embassy, the agency contract between the company and the local agent, CE, 510(k) or PMA evidence for the device class, post-marketing monitoring requirements, full product information and user manuals, packaging and brochures, a sample and certificate of analysis where the device type needs one, an EC Declaration of Conformity, safety and efficacy data for Class III and IV devices, and a conformity certificate for devices made from animal products. Some devices also need laboratory analysis and pricing. The certificate is valid for five years from the date of the registration committee's approval.

EDE's published times cover its own review. Document preparation, embassy attestation and answers to EDE's correction requests come on top, and EDE does not publish an end-to-end figure.

An EDE marketing authorization lets a device be sold in the UAE. Using radiation equipment needs a separate approval from the Federal Authority for Nuclear Regulation (FANR). Under Federal Law by Decree No. 6 of 2009 on the peaceful uses of nuclear energy, any business, including free zone entities, that possesses, uses, imports or stores X-ray generators, radioactive materials or other sources of ionizing radiation must hold a FANR licence. The licence is valid for three years. For activities that do not need full regulatory control, FANR issues a registration certificate instead, under its regulation FANR-REG-29.

FANR sorts licences by risk. Its low-risk examples include mammography, panoramic dental X-ray (OPG) and bone densitometers. Its medium-risk examples include conventional and mobile medical X-ray and dental cone beam CT. Its high-risk examples include medical CT scanners, angiography, fluoroscopy, C-arms, PET isotopes and radioactive sources. MRI and ultrasound do not use ionizing radiation, so FANR does not license them.

For low- and medium-risk applications, FANR asks for the application form on its e-licensing system, a justification of need, facility floor layouts, a Protection and Safety Programme signed by senior management, and a safety assessment by a technical service provider that FANR has approved or licensed. The facility names a Radiation Protection Officer and sends a designation letter from the responsible person, the officer's CV, and a radiation safety training certificate or a commitment to complete the training within 3 months. High-risk practices go through three stages: approval of the safety assessment before construction, a licence to possess, and a licence to use. FANR's process includes a location inspection, and its published service delivery time is 10 days.

Under Article 6 of Federal Decree-Law No. 38 of 2024, a marketing authorization application must come from a pharmaceutical establishment licensed as a marketing office, a manufacturer of medical products, a contract manufacturer, or the medical warehouse that the marketing authorization holder designates. Under Article 21, the marketing authorization holder must appoint at least one qualified person resident in the UAE. Under Article 22, it must designate at least two EDE-licensed establishments to import the product and one or more licensed establishments to distribute it, and name one main establishment that handles all licensing, pharmacovigilance and lifecycle work for the product. One application is filed per product, however many establishments are designated.

A registration in another country does not replace this. Article 5 bars the import, sale or use of a medical product in the UAE until EDE grants it a marketing authorization. Approvals from other regulators, such as a CE certificate or FDA clearance, are evidence in the EDE file, and Article 6 lets EDE evaluate a product against approvals issued by reference countries. A group with clinics in Saudi Arabia and the UAE runs a separate registration in each country.

For a clinic, this means you buy a registered device from one of the licensed establishments the marketing authorization holder has designated, and you do not register it again. To import a device yourself, the importer must hold an EDE medical warehouse licence. EDE's Licensing of a Medical Warehouse service lists an AED 100 application fee, AED 1,000 per primary inspection, AED 1,000 per final inspection and an AED 7,500 final licence fee. It also needs a responsible pharmacist licensed by the federal health regulator, and an equipment engineer for warehouses that deal only in medical devices.

Start the regulatory checks when you shortlist equipment, not when it is delivered.

At the request-for-proposal stage, ask each supplier for the EDE marketing authorization of the exact model and check it in EDE's registered medical product directory on ede.gov.ae. Ask which licensed establishment will import and supply it. If the model is not registered, ask whether the manufacturer is registered with EDE. A new manufacturer registration (published time 2 to 4 weeks) comes before the device application (published time 45 working days), and neither figure includes document preparation, embassy attestation or correction rounds. If the product's status is unclear, a classification letter costs AED 500 and takes 10 working days.

For imaging equipment, commission the shielding design, safety assessment and Protection and Safety Programme while the room is being designed, because FANR asks for floor layouts and a safety assessment with the application. A late fit-out delays the FANR licence, and the scanner or X-ray unit cannot be used until the licence is issued.

Before your facility inspection, ask your emirate's health regulator which device documents it will check.

Under Article 21 of Federal Decree-Law No. 38 of 2024, the marketing authorization holder must track the product through distribution channels, monitor how it performs, receive reports from health facilities on its effectiveness, safety and quality, follow EDE's pharmacovigilance guidance, and manage recalls. Article 6 requires the applicant to run quality assurance, product traceability, pharmacovigilance and post-marketing follow-up systems. Reporting side effects of medicines and medical products is one of the services that moved to EDE.

The marketing authorization is valid for five years, and the renewal application goes in 90 days before it expires (Article 7). EDE's renewal service costs AED 100 plus AED 2,500, has a published service time of 15 working days, and must be filed by an EDE-licensed medical warehouse. It needs the original registration certificate, a valid manufacturer registration certificate, a free sale or registration certificate attested by the UAE Embassy, copies of any minor-change certificates, the CE, 510(k) or PMA evidence, and an EC Declaration of Conformity. Under Article 17, EDE can cancel an authorization if an imported product is not placed on the market within one year of approval without an acceptable reason.

Changes to a registered device go to EDE. Under Article 16, the marketing authorization holder applies for minor changes, such as a change of packaging or leaflet, of manufacturing site, of marketing authorization holder, or minor changes to the manufacturing method, without a new marketing authorization. Ask your supplier whether a software or hardware update needs an EDE filing before you install it.

FANR licences are valid for three years. FANR has separate services to renew and to amend a licence.