To market Medical Devices and In Vitro Diagnostics in Kuwait, registration of products with The Ministry of Health (MOH) via the Pharmaceutical & Herbal Medicines Registration & Control Administration department is required, which is responsible for assessing applications and granting licences.

The application for registration must be completed, signed and stamped by the Authorised Local Representative and contain the appropriate documentation to prove compliance with Ministerial Decree No. 13 of 2022.

The application dossier must include administrative documents, information about the medical device, labelling information, declaration of conformity with the essential safety and performance principles, description and specifications of the device, including variants and accessories (STED documentation), other information, such as a list of countries where the device is already marketed. The Dossier must also contain information on the Authorised Local Representative, the Manufacturer and the Plant (if separate).

Further requirements vary according to the risk class of the device. For Class C devices, for example, clinical investigations are required; for Class D devices, evidence must be given of the control process of the essential raw materials used in the product assembly, production and storage.

Further details, research or tests to demonstrate the safety and efficacy of the device may be requested during the application evaluation.

Upon approval of the application, a certificate of registration is obtained.

Applicant

The foreign manufacturer marketing Medical Devices in Kuwait must appoint an Authorised Local Representative responsible for product compliance from registration to post-market surveillance.

Timeframe and Costs

The approval time for an application ranges from 6 to 8 weeks.
Fees for registering a medical device range from $80 approx.

Validity

The registration certificate is valid for five years. Renewal or cancellation of registrations is foreseen.

Labelling and documentation language

Arabic or Arabic and English.

Useful information

Kuwait’s regulations follow the principles of harmonisation with the European Medical Device Regulation, as can be seen, for example, from the similarity with the classification rules (four risk classes).
It also follows the guidelines of the International Medical Device Regulators Forum (IMDRF).