Medical device registration and documents in the UAE: what to ask your supplier

Hospitals, clinics and laboratories in the UAE are expected to use medical devices that are registered for the UAE market and supported by complete documentation. Equipment that arrives without the right papers can hold up installation, licensing inspections and tender evaluations. These are the questions worth asking a supplier before you place an order.

Who regulates what

• Federal level: medical devices placed on the UAE market are registered with the federal authority for medical products. This has been the Ministry of Health and Prevention (MOHAP); the Emirates Drug Establishment (EDE), established in 2023, has been set up to take over the regulation of medical products. Ask which authority issued the registration you are shown.
• Emirate level: the Dubai Health Authority (DHA), the Department of Health – Abu Dhabi (DoH) and, in the other emirates, mainly MOHAP license healthcare facilities and professionals. Their facility standards and inspections determine the equipment records you must keep.
• Healthcare free zones: facilities in zones such as Dubai Healthcare City follow the rules of their zone authority in addition to the federal requirements.

1. Is the device registered for the UAE, and under which name?

Ask for the registration certificate or the entry in the authority's register, and check that it covers:

• the exact model and, where relevant, the accessories and consumables you are buying — the registration of one model does not automatically cover its variants or accessories;
• the legal manufacturer named on the device label;
• the registration holder or local authorised representative, and the supplier's right to sell the device;
• the validity date of the registration.

2. What evidence of conformity does the manufacturer hold?

Registration builds on the manufacturer's conformity evidence from reference markets. Ask for:

• the EU declaration of conformity and, for devices above the lowest risk class, the CE certificate issued by a notified body — under the EU Medical Device Regulation (EU) 2017/745, or under the earlier Directive 93/42/EEC where a certificate still benefits from the transition arrangements;
• US FDA clearance or approval where the supplier refers to it — a 510(k) number can be checked in the FDA's public database;
• the manufacturer's ISO 13485 quality management certificate.

Check that each certificate names the same manufacturer, covers the model you are buying and has not expired.

3. Which risk class does the device belong to?

The risk class decides how much evidence the authorities require and is often asked for in tenders. Ask for the class under the EU rules and the class under which the device is registered in the UAE.

4. Which documents come with the device?

• instructions for use and labels, and the languages in which they are available;
• a technical datasheet with the electrical, water and environmental requirements;
• the installation and commissioning report, and user training records;
• a warranty certificate stating when the warranty starts;
• for measuring devices, a calibration certificate with traceability to national or international standards;
• the preventive maintenance schedule and the list of consumables and spare parts;
• the certificate of origin and commercial invoice that customs and some tenders require.

5. Who supports the device after delivery?

Ask who installs and services the equipment in the UAE, whether the engineers are trained by the manufacturer, which spare parts are stocked locally and for how many years parts will remain available. For critical equipment, ask about response times and loan units.

6. How are safety notices and recalls handled?

Manufacturers issue field safety notices when a problem is found. Your supplier should keep the delivery records — serial and lot numbers per customer — needed to reach you, and explain how adverse incidents are reported to the manufacturer and the authority. Keep your own record of serial and lot numbers, so that you can act quickly.

7. Does the device store or send patient data?

Connected devices and software that store or transmit patient information are subject to UAE rules on health data, including Federal Law No. 2 of 2019 on the use of information and communication technology in health fields, and to the data requirements of your licensing authority. Ask where the data is stored, how access is controlled, and how software updates and security fixes are delivered.

Documents commonly requested in tenders

Public and private tenders commonly ask for the supplier's trade licence, the device registration, CE or FDA certificates, the manufacturer's ISO 13485 certificate, a manufacturer's authorisation letter, datasheets and a statement of compliance with the specification. Asking for them at the quotation stage avoids last-minute gaps.

How we can help

Our product pages show the documents and regulatory details we hold for each model. For a quotation or a tender, tell us which documents you need and we will confirm what we can provide for each line. Request a quotation or contact our team.