Gaois

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2 results

  1. SOCIAL QUESTIONS|health|health policy
    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.
  2. SOCIAL QUESTIONS|health · PRODUCTION, TECHNOLOGY AND RESEARCH|technology and technical regulations|technical regulations
    an Tascfhórsa um Chomhchuibhiú Domhanda Reference "Rialachán (AE) Uimh. 746/2017 maidir le feistí leighis diagnóiseacha in vitro agus lena n-aisghairtear Treoir 98/79/CE agus Cinneadh 2010/227/AE ón gCoimisiún, CELEX:32017R0746/GA ;Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    GHTF Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Global Harmonization Task Force | GHTF
    de
    Definition freiwilliger internationaler Zusammenschluss aus Vertretern der für Medizinprodukte zuständigen Regulierungsbehörden und Berufsverbänden aus Europa, den Vereinigten Staaten von Amerika (USA), Kanada, Japan und Australien Reference "2013/172/EU: Empfehlung der Kommission vom 5. April 2013 über einen gemeinsamen Rahmen für ein System einmaliger Produktkennzeichnung für Medizinprodukte in der Union CELEX:32013H0172/DE"
    Comment wurde im Jahr 1992 in dem Bemühen gegründet, dem wachsenden Bedarf an internationaler Harmonisierung bei der Regulierung von Medizinprodukten Rechnung zu tragen. Das Mandat der GHTF endete im Dezember 2012
    Global Harmonization Task Force | Global Harmonization Task Force on Medical Devices | GHTF
    en
    Comment "The Global Harmonization Task Force (GHTF) no longer exists, and has been permanently replaced by the International Medical Device Regulators Forum (IMDRF) [ IATE:3571963 ]. Reference: International Medical Device Regulators Forum > GHTF Archive, http://www.imdrf.org/ghtf/ghtf-archives.asp [23.2.2017]"