Gaois

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  1. SOCIAL QUESTIONS|health|health policy

    #641431

    IATE #3501893
    Ainmníocht Dhomhanda na bhFeistí Leighis Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Globale Nomenklatur für Medizinprodukte | GMDN
    de
    Definition Liste von Gattungsbezeichnungen gemäß ISO 15225:2000 für die Identifikation und den regulativen Datenaustausch aller Medizinprodukte Reference "EP-TermCoord (Rau), basierend auf: GMDN Agency, Services, What is GMDN, GMDN-Datenbank (6.4.2021)"
    Global Medical Device Nomenclature | GMDN
    en
    Definition comprehensive system of internationally recognised coded descriptors in the format of preferred terms with definitions used to generically identify medical devices and related health care products Reference "GMDN > About GMDN > GMDN Nomenclature, http://www.gmdnagency.com/Info.aspx?pageid=2 [16.11.2010]"
    Comment Medical device experts from around the world (manufacturers, healthcare authorities and regulators) compiled the initial GMDN nomenclature based on the ISO 15225 standard. The work was mandated by the European Commission in order to provide the necessary tool to carry out many of the obligations following the implementation of the Medical Devices Directives. Also, to meet similar needs at the global level as identified in the global harmonisation activities of GHTF by its members, notably USA (FDA), Canada, European member states, Japan, Australia and now by many other countries/regions. This included some 4 years of international consultation and discussion culminating in the Technical Report (CEN Report CR 14230), which was created within the framework of CEN and ISO.