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A comparison study of Taiwan regulation and GHTF regulatory model on in vitro diagnostic medical devices.
Tsai, Wen-Wei; Tu, Pei-Weng; Lin, Hsin-Hui; Wang, Yin-Hsuan; Wu, Shiow-Ing; Fan, Yin-Ting.
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  • Tsai WW; a Division of Medical Devices and Cosmetics , Food and Drug Administration, Ministry of Health and Welfare , Taipei , Taiwan.
  • Tu PW; a Division of Medical Devices and Cosmetics , Food and Drug Administration, Ministry of Health and Welfare , Taipei , Taiwan.
  • Lin HH; a Division of Medical Devices and Cosmetics , Food and Drug Administration, Ministry of Health and Welfare , Taipei , Taiwan.
  • Wang YH; b Office of Medical Device Evaluation , Center for Measurement Standards, Industrial Technology Research Institute , Hsinchu , Taiwan.
  • Wu SI; c Food and Drug Administration , Ministry of Health and Welfare , Taipei , Taiwan.
  • Fan YT; b Office of Medical Device Evaluation , Center for Measurement Standards, Industrial Technology Research Institute , Hsinchu , Taiwan.
Expert Rev Med Devices ; 14(4): 285-296, 2017 Apr.
Article en En | MEDLINE | ID: mdl-28298137
INTRODUCTION: In Taiwan, In Vitro Diagnostic Medical Device (IVD) is regulated as medical device since 1987, and the implementation of IVD registration was fully completed in 2005. The management system of IVD medical device is highly similar with a guidance 'The GHTF Regulatory Model' developed by Global Harmonization Task Force (GHTF) in 2011 for use of regulation development on medical devices. Area covered: In this study, the Regulatory Model developed by GHTF was compared with Taiwanese IVD management system and it has shown that these two regulatory frameworks are highly similar. Expert commentary: The experience of IVD management in Taiwan can serve a strong evidence to prove the feasibility and effectiveness of GHTF Regulatory Model.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Juego de Reactivos para Diagnóstico / Aprobación de Recursos Tipo de estudio: Diagnostic_studies / Guideline Límite: Humans País/Región como asunto: Asia Idioma: En Revista: Expert Rev Med Devices Asunto de la revista: DIAGNOSTICO POR IMAGEM / TERAPEUTICA Año: 2017 Tipo del documento: Article País de afiliación: Taiwán Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Juego de Reactivos para Diagnóstico / Aprobación de Recursos Tipo de estudio: Diagnostic_studies / Guideline Límite: Humans País/Región como asunto: Asia Idioma: En Revista: Expert Rev Med Devices Asunto de la revista: DIAGNOSTICO POR IMAGEM / TERAPEUTICA Año: 2017 Tipo del documento: Article País de afiliación: Taiwán Pais de publicación: Reino Unido