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KMID : 1142220120070010027
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Regulatory Research on Food, Drug & Cosmetic
2012 Volume.7 No. 1 p.27 ~ p.37
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Codification of Safety Information Including Adverse Events of Medical Devicese)
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Kim Young
Jeong H.-W.
Kang Young-Kyu
Ahn J.-Y.
Lee H.-J.
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Abstract
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Codification of medical device safety information is essential in promotion of medical device safety information reporting and in systemization of reported information. This research aims to suggest code system of medical device safety information applicable to Korea. Literature review was conducted on the globally used code systems, including GHTF, ISO code system, MedDRA, US FDA code system. The assessment showed that US FDA code system is the most suitable system for Korea in consideration of its stratified structure and its applicability in data analysis. The conclusion was confirmed by experts in medical device industry. The principal institute organized consultation meetings and a workshop to request for opinions of industry leaders. In combination of literature review and experts' opinion, the principal institute finally concluded that US FDA code system is the most suitable. Additionally, US FDA code system was translated to develop a Korean version of code system, and suggestions for revising current medical devices regulations were developed to implementation of this code system in this study.
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KEYWORD
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Medical device, Adverse Event, Codification
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FullTexts / Linksout information
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