Kuwait Medical Devices
Kuwait’s Ministry of Health (MOH) recently issued three new ministerial decrees to regulate the registration and distribution of medical devices, supplies, and health products, and to streamline medicine prescription work in the public and private medical institutions.
The first decree: registration and distribution of medical devices. MOH called ministerial decree number 13 of 2022 a move in the field of regulation and control of medical devices in Kuwait in line with international rules and standards including biomedical devices. The new ministerial decision classifies medical devices into four categories in terms of how they are used and their impact on their users, so that the regulatory conditions, studies, and requirements for registration are commensurate with the category to which the medical device is subjected.
The impact for American companies is expected to help U.S. companies better understand the registration requirements set by the ministry and possibly shorten the processing time needed to register a device in Kuwait.
The second decree: regulation and circulation of health products. Ministerial decree 14 of 2022 regards the regulation and circulation of health products. This decree aims to allow Kuwait’s health system to keep pace with the continuous developments and procedures to be followed for controlling the production and registration of health products in Kuwait. The health products include pharmaceuticals that are used to preserve human health or help diagnose, prevent, or contribute to the treatment of some low-risk conditions, or compensate for the deficiencies in some physiological functions in the human body.
The impact for American companies is expected to help U.S. companies better understand the regulation and circulation of health products set by the ministry and possibly shorten the processing time needed to register a health product in Kuwait.
The third decree: regulation of medical prescriptions. Ministry decree number 12 of 2022 regulates medical prescriptions. It specifies the information that must be available on the prescription, including the scientific name, as well as the role of the clinical pharmacist. MOH indicated that writing treatment with the scientific name aims to achieve several advantages, including the patient’s right to know the scientific name and the available alternatives, as well as reducing the occurrence of medication errors. The scientific name is universal and known to health practitioners, while brand names vary by country and many health providers and patients may not be familiar with them.
It is expected that the impact for American companies is that they will better understand the regulation medical prescriptions set by the ministry and how better patient’s right can benefit both consumers and medical companies.
U.S. companies need to work closely with their local partners to identify how the decree(s) would affect their business in Kuwait. In general, the new decree aims to enhance the efficiency of the registration and distribution process for foreign companies and their local agents.
Contact information: Drug and Food Control Administration, Kuwait Ministry of Health Email: kdfc@moh.gov.kw Phone: +965 2481 1508, Phone: +965 2481 1532
To learn more about these decrees or business opportunities in Kuwait, please contact Commercial Specialist: Yousif.Almahdi@trade.gov