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Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans. The main purpose of the GMDN is to provide health authorities / regulators, health care providers, medical device manufacturers and suppliers, conformity assessment bodies and others with a single generic naming system that will support patient safety. Medical device experts from around the world (manufacturers, healthcare authorities and regulators) compiled the GMDN, based on the international standard ISO 15225.〔ISO 15225:2010 "Medical devices -- Quality management -- Medical device nomenclature data structure" http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=50728〕 The work was mandated by the European Commission in order to provide the necessary tool to carry out the implementation of the Medical Devices Directive,〔EC Medical Devices regulatory framework http://ec.europa.eu/health/medical-devices/regulatory-framework/index_en.htm〕 including the European databank for medical devices (Eudamed).〔http://ec.europa.eu/health/medical-devices/market-surveillance-vigilance/index_en.htm〕 ==Governance== The GMDN meets the need to identify medical devices at the global level, as identified in the Global Harmonization Task Force (GHTF) and its founding members: USA (Food and Drug Administration), Canada (Health Canada), EU (European Commission), Japan (Ministry of Health, Labour and Welfare), Australia (Therapeutic Goods Administration)〔TGA website http://www.tga.gov.au/industry/devices.htm〕 and now by many other countries and regions. GMDN is managed by the GMDN Agency, a non-profit organization and Registered Charity,〔Charitable organization#United Kingdom〕 which reports to its Board of Trustees, that represent medical device regulators and industry. 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Global Medical Device Nomenclature」の詳細全文を読む スポンサード リンク
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