A comparison study of Taiwan regulation and GHTF regulatory model on in vitro diagnostic medical devices

被引：0

作者：

Tsai, Wen-Wei ^{[1
]}

Tu, Pei-Weng ^{[1
]}

Lin, Hsin-Hui ^{[1
]}

Wang, Yin-Hsuan ^{[2
]}

Wu, Shiow-Ing ^{[3
]}

Fan, Yin-Ting ^{[2
]}

机构：

[1] Minist Hlth & Welf, Div Med Devices & Cosmet, Food & Drug Adm, Taipei, Taiwan

[2] Ind Technol Res Inst, Ctr Measurement Stand, Off Med Device Evaluat, Hsinchu, Taiwan

[3] Minist Hlth & Welf, Food & Drug Adm, Taipei, Taiwan

来源：

EXPERT REVIEW OF MEDICAL DEVICES | 2017年 / 14卷 / 04期

关键词：

In Vitro Diagnostic Medical Device (IVD); Global Harmonization Task Force (GHTF); total product life cycle; regulation; Next Generation Sequencing (NGS); laboratory developed test (LDT);

D O I：

10.1080/17434440.2017.1307732

中图分类号：

R318 [生物医学工程];

学科分类号：

0831 ;

摘要：

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.

引用

页码：285 / 296

页数：12

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