The Decree supplements the laws and various decrees that regulate the pharmacy profession and the trading of pharmaceutical products.
Lulwa AlhammadSenior Associate,Corporate Commercial
In January 2022, the Kuwait Ministry of Health (“MOH”) issued Ministerial Decree No. 13 of 2022 (“Decree”) regarding the registration and release of medical devices in Kuwait. The Decree supplements the laws and various decrees that regulate the pharmacy profession and the trading of pharmaceutical products.
The Decree applies to all products that fall within the definition of the term “medical device”. The Decree defines a medical device as “any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purposes of:
diagnosis, prevention, monitoring, treatment or alleviation of disease;
diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
investigation, replacement, modification, or support of the anatomy or of a physiological process;
supporting or sustaining life;
control of conception;
disinfection of medical devices;
providing information by means of in vitro examination of specimens derived from the human body; and does not achieve its primary intended action by pharmacological, immunological, or metabolic means, in or on the human body, but which may be assisted in its intended function by such means;
disinfection substance for medical devices or medical instruments;
aids for persons with disabilities;
devices incorporating animal and/ or human tissues;
devices for in vitro fertilization or assisted reproduction technologies; and
devices for cosmetic/aesthetic.”
The Decree takes into consideration that all medical devices are different and can be categorised accordingly under a graduated system of control corresponding to the level of potential hazard linked to the device in question. When classifying medical devices, the Decree takes into consideration, among others, factors such as whether the medical device is invasive (and if so, to what extent and what duration), whether the medical device could modify blood or other bodily fluids and if the said device would be used in combination with another medical device.
The classification system comprises of four classes with “Class A” representing the lowest risk and “Class D” representing the highest risk
The classification system comprises of four classes with “Class A” representing the lowest risk and “Class D” representing the highest risk. Examples of low risk devices include, but are not limited to, bandages and tongue depressors, whilst heart valves and implantable defibrillators would fall under the ambit of high risk devices.
The manufacturer is required to document its justification for placing its product in a particular class. If, based on the manufacturer’s intended uses, two or more classification rules apply to the said device, the device will be allocated the highest level of classification.
The medical devices must be registered with the Pharmaceutical & Herbal Medicines & Registration & Control Administration department of MOH. The Decree lists the general requirements for registration of the medical devices. Noting that medical devices under the more hazardous categories will require additional documentations, such as clinical studies on the medical device. The general requirements for registering the medical device are as follows:
Medical device information;
Declaration of conformity;
Summary Technical Documentation (STED documentation); and
The aforementioned information for registration of the medical device must relate to the local agent, manufacturer and/or factory.
With respect to renewal of registration, a renewal application form must be submitted along with supplementary documents and must be submitted six months prior to the registration expiry date.
The Decree also addresses the circumstances where a medical device’s registration may be suspended. Such instances include. but are not limited to, the following:
If the product or the legal manufacturer company is suspended in country of origin;
Evidence of non-compliance, safety or efficacy of the device;
If there are discrepancies in the documents submitted; or
If the company does not comply with current GMP standards.
Additionally, the Decree details the basic requirements for transferring the medical device to another local agent. A medical device transfer application form, store license issued from the MOH, original legalized letter of appointment for the new local agent ( issued by the legal manufacturer of the company of the said medical device), original legalized termination letter of the old agent ( issued by the legal manufacturer of the company of the said medical device), and list of the registered products issued by the legal manufacturer must be submitted in order to effectuate a transfer to a new local agent. Only medical devices with valid registrations will be transferred.
The Decree includes significant requirements with regards to the registration, transfer and suspension of medical devices in Kuwait, which the foreign principal must be mindful of prior to conducting business in Kuwait. The foreign principal will also need to be mindful of the other various Kuwait regulations on doing business in Kuwait, namely the regulations regarding commercial agencies.
For further information, please contact email@example.com.
Published in January 2023