Medical devices and in vitro diagnostic devices (IVDs) are regulated by the Ministry of Health and Prevention (MOHAP), Homepage | Ministry of Health and Prevention - UAE (mohap.gov.ae)

Drug Control Department. The regulatory framework is based on Federal Law No. 8 of 2019 and associated guidance.

However, the regulatory system in the UAE is primarily based on case-by-case decisions by the MOHAP, and the written

guidance is not always followed in practice

APPLICANT

The appointment of an Authorised Representative (Agent) in the territory is required. Ther is also a local approved Importer required.

Process

The Agent submits a classification request to the MOHAP, who will review the key product information including the intended use and any other global marketing approvals.

Upon review, the MOHAP issues a Classification Letter. The Classification Letter details the risk classification and whether the product is subject to registration.

Once the class is known The Agent can apply for Registion the manufacturing site via the Services page on the MOHAP website to receive a registration certificate for the factory, nd then can sunmit a copy of the technical file and potentially samples of the product (that will be used for test and inspection). Generally devises that are usied by “professionals” do not require registration only classification.

The Drug Control Department reviews the application and issues a Registration Certificate allowing the sale of the devices.

Time and Costs

The establishment licence at the expense of the Authorised Representative requires the payment of an initial application fee: 100 AED and a further Registration fee of a medical device: 5,000 AED

The classification can take 30-45 days and the actual Registration can take 3 to 6 months

DOCUMENTATION LANGUAGE AND LABELLING

The product registration dossier can be drafted in English.

The labelling (labels and instructions for use) for Medical Devices for professional use can be made available in English, while that for devices for domestic use shall be in English and Arabic. In all cases, in addition to the identification details of the foreign manufacturer, it must also include those of the local Authorised Representative/importer.

Upadte

Ther is a new regulation which is due to be enforced that all deviecs must be registered under two separate importers.