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Master Thesis

L'harmonisation internationale des réglementations relatives aux dispositifs médicaux de diagnostic in vitro‎ : intérêt des travaux du GHTF (Global Harmonization Task Force) et perspectives d'évolution de la réglementation

Abstract : In Vitro Diagnostic (IVD) medical device means a medical device, whether used alone or in combination, intended by the manufacturer for the in-vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes. International commercialization of IVD medical devices is taking place in a more and more demanding context especially regarding security and performance issues. However regulations related to this kind of product are specific to each country. It is in this context that was conceived in 1992 the Global Harmonization Task Force (GHTF), a voluntary group of representatives from five founding members (the European Union, the United States, Canada, Japan and Australia) whose goal was to promote the convergence of regulatory requirements of countries concerning medical devices and IVD medical devices. The objective of this thesis is to report on the status of current regulations applying to each of its founding members with a special focus on GHTF recommendations (definition, classification, conformity assessment procedure, STED, post market surveillance and labelling) in order to determine the influence of the GHTF on their national regulations and to estimate the level of convergence and interest for its work.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-00741680
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Submitted on : Monday, October 15, 2012 - 9:26:11 AM
Last modification on : Tuesday, May 11, 2021 - 11:36:17 AM
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  • HAL Id : dumas-00741680, version 1

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Laurence Bruel. L'harmonisation internationale des réglementations relatives aux dispositifs médicaux de diagnostic in vitro‎ : intérêt des travaux du GHTF (Global Harmonization Task Force) et perspectives d'évolution de la réglementation. Sciences pharmaceutiques. 2012. ⟨dumas-00741680⟩

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