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Ukraine implements GMDN to improve procurement of medical devices

18 July 2018
105

On July 18, the Ministry of Health of Ukraine and the Ministry of Economic Development and Trade of Ukraine signed a memorandum of cooperation with the GMDN Agency (the UK). Starting next year, all Ukrainian health facilities and medical institutions will start using the Global Medical Device Nomenclature (GMDN) tool to identify all medical devices and products, at the generic level, in a meaningful manner that can be understood by all users. The use of this classifier will simplify the procurement process and help prevent corruption. In addition, hospitals nationwide will be able to purchase more high-quality supplies, instruments, implants and other medical devices.

The Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products, which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans. 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. Today, the system includes about 7.5 thousand manufacturers from around the world and more than one million medical products.

"Now we take another step forward in developing modern health care in Ukraine - an important step towards integrating into the European and international medical communities. This is a major breakthrough. We are the first of the post-Soviet states to introduce an international medical device classifier. This will have positive effects for all – the state, health facilities and practitioners, manufacturers, and, most importantly, citizens of Ukraine," underlined Dr. Ulana Suprun, acting Minister of Health of Ukraine.

Before, health facilities and institutions had free access to formulating lists of medical devices, could manipulate technical specifications and thereby drive up prices and promote corruption in the public procurement bidding process. The introduction of the GMDN tool should eliminate such activities, as each term in the GMDN Database has 3 components: preferred term code (5-digit number), preferred term name, and preferred term definition. It allows doctors and purchasers to find out the specific characteristics and properties of a particular medical product. This will optimize the procurement of medical devices by health institutions and minimize manipulation risks.

"The GMDN is not only an effective procurement tool. The GMDN introduction implies the use of the uniform standards, which will have a significant impact on the market of medical products in Ukraine. In particular, it will contribute to accelarating the procurement of medicines and healthcare products, lowering prices, and simplifying the import of medical devices into the territory of Ukraine. In addition, the use of the GMDN tool will allow the Ukrainian manufacturers of medical devices to access international markets," noted Roman Ilyk, deputy Minister of Health of Ukraine.

The Ministry of Health of Ukraine plans to integrate the GMDN classification into the ProZorro public e-procurement system and has already initiated translation of the GMDN database, which contains over one million terms. The first 30 000 positions are to be translated by the end of this year.

"Today, exploiting the lack of a uniform classification of medical devices, health facilities and institutions can avoid competitive procurement procedures by breaking procurement items into parts or purchasing medical devices under direct arrangements at much higher prices. Moreover, sometimes hospitals adjust the medical device specifications in bidding documents, so that specific participants are in the best position to win the tender. The introduction of a uniform classification of medical devices and its integration into ProZorro will make procurement of medical devices more transparent. In a year, the use of this tool should become customary making the procurement transparent," explained Maksym Nefiodov, First Deputy Minister of Economic Development and Trade of Ukraine.

The introduction of the GMDN classification is another important step forward in Ukraine's healthcare transformation and European integration processes. Under the EU-Ukraine Association Agreement, Ukraine has committed to taking measures to gradually achieve full conformity with EU technical regulations and standards, quality infrastructure (standardization, metrology, accreditation and conformity assessment) and market surveillance procedures, as well as to adhere to principles and practices outlined in the EU decisions and guidelines. This should encourage Ukrainian producers to manufacturer high-quality products and access international markets.

"We are delighted to see Ukraine joining the global community. The introduction of this tool should become a universal solution to many of the current problems in the medical device market. The GMDN is an international practice that will contribute to improving market activities, ensuring interaction between all participants in the supply chain, and framing requirements for all market participants. We are working to make the GMDN a uniform tool used worldwide," summed up Mark Wasmuth, CEO at the GMDN Agency.

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