1. Authorities

Medical Devices - Class A
Kuwait

This section provides an overview of the Authorities involved in setting regulations and managing compliance with the medical devices in scope.

The Ministry of Health, Drug, and Food Control (MoH), through its Pharmaceutical and Herbal Medicines Control and Registration Administration, is the government agency entrusted to serve the Kuwait medical device industry. The Administration oversees the evaluation, classification, registration, importation, and licensing of all medical devices.

Kuwait's Medical Device regulation is highly based on European Council Directives for medical devices 93/42/EEC and active implantable medical devices 90/385/EEC and from guidelines issued by the International Medical Device Regulators Forum (IMDRF).

The Ministerial Decree for the Registration and Release of Medical Devices M.D. (13)/2022 sets out the applicable requirements.