Ministry of Health of Ukraine introduces GMDN classification for medical devices
The Global Medical Device Nomenclature (GMDN) is an international tool for identifying all medical devices and products, at the generic level, in a meaningful manner that can be understood by all users. It allows doctors and purchasers to find out the specific characteristics and properties of a particular medical product.
The Ministry of Health of Ukraine plans to integrate the GMDN classification into the ProZorro public e-procurement system. This will allow optimizing the procurement of medical devices by health institutions and minimizing the risk of manipulations.
"The introduction of the GMDN classification is another important step forward in Ukraine's European integration process. It will make procurement of medical devices more transparent. Each chief physician will be able to check whether the manufacturer who won the tender offers the hospital the necessary equipment, not the device with similar functionality. This will minimize the risk of manipulations by both unscrupulous producers and distributors, which will contribute to a more rational use of state budget funds", commented Roman Ilyk, Deputy Minister of Health of Ukraine.
The GMDN will facilitate data exchange between manufacturers, regulators and healthcare authorities, as well as the dialogue between the Ukrainian physicians and their foreign colleagues, since they will speak the same language and use the same names for all medical devices and innovative technologies. It will also simplify the import of medical devices into the territory of Ukraine.
The GMDN Agency has already granted the Ministry of Health of Ukraine access to the Global Medical Device Nomenclature database, which is currently being translated into the Ukrainian language.
The Global Medical Device Nomenclature (GMDN) is a list of generic names used to identify all medical device products. Such products include those used in the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans. The main purpose of the GMDN is to provide health authorities and regulators, health care providers, manufacturers and others with a naming system that can be used to exchange medical device information and support patient safety.
Each GMDN Preferred Term (PT) has 3 components: preferred term code (5-digit number), preferred term name, and preferred term definition. Today, the system includes about 7.5 thousand manufacturers from around the world and more than one million medical products.
The GMDN is recommended by the International Medical Device Regulators Forum (IMDRF) and is now used by over 70 national medical device regulators to support their activity.