AI Article Synopsis
- In Taiwan, In Vitro Diagnostic Medical Devices (IVDs) have been regulated as medical devices since 1987, with full registration implementation completed in 2005.
- The Taiwanese IVD management system closely aligns with the Global Harmonization Task Force (GHTF) Regulatory Model established in 2011.
- The findings suggest that Taiwan's experience with IVD regulation supports the effectiveness and feasibility of the GHTF Regulatory Model for other regions.
Article 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.
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| http://dx.doi.org/10.1080/17434440.2017.1307732 | DOI Listing |
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