title: A comparison study of Taiwan regulation and GHTF regulatory model on in vitro diagnostic medical devices.
abstract: 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.
authors.affiliation: a Division of Medical Devices and Cosmetics , Food and Drug Administration, Ministry of Health and Welfare , Taipei , Taiwan.
authors.forename: Wen-Wei
authors.initials: WW
authors.lastname: Tsai
authors.affiliation: a Division of Medical Devices and Cosmetics , Food and Drug Administration, Ministry of Health and Welfare , Taipei , Taiwan.
authors.forename: Pei-Weng
authors.initials: PW
authors.lastname: Tu
authors.affiliation: a Division of Medical Devices and Cosmetics , Food and Drug Administration, Ministry of Health and Welfare , Taipei , Taiwan.
authors.forename: Hsin-Hui
authors.initials: HH
authors.lastname: Lin
authors.affiliation: b Office of Medical Device Evaluation , Center for Measurement Standards, Industrial Technology Research Institute , Hsinchu , Taiwan.
authors.forename: Yin-Hsuan
authors.initials: YH
authors.lastname: Wang
authors.affiliation: c Food and Drug Administration , Ministry of Health and Welfare , Taipei , Taiwan.
authors.forename: Shiow-Ing
authors.initials: SI
authors.lastname: Wu
authors.affiliation: b Office of Medical Device Evaluation , Center for Measurement Standards, Industrial Technology Research Institute , Hsinchu , Taiwan.
authors.forename: Yin-Ting
authors.initials: YT
authors.lastname: Fan
mesh_terms: D018795:Device Approval; D006801:Humans; D008962:Models, Theoretical; D011933:Reagent Kits, Diagnostic; D013624:Taiwan
chemical_list: D011933:Reagent Kits, Diagnostic
keywords: Global Harmonization Task Force (GHTF); In Vitro Diagnostic Medical Device (IVD); Next Generation Sequencing (NGS); laboratory developed test (LDT); regulation; total product life cycle