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KMID : 1142220170120010039
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Regulatory Research on Food, Drug & Cosmetic
2017 Volume.12 No. 1 p.39 ~ p.49
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Development of Standards for Medical Devices Classified as Grade 1
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Youn Kwan-Sik
Lim Hong-Seok
Kim Jung-Ho
Moon Dae-Eun
Lee Yoon-Joo
Kim Sung-Min
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Abstract
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According to the “Regulations Regarding the Classification of Medical Device Items and Items” notified by the Ministry of Food and Drug Safety, there are only 33 standards for some of the 669 items of Medical Devices classified as grade 1. In the case of Medical Devices classified as grade 1, there is no need for separate test items or standards at the time of reporting, so it is necessary to develop standards for establishing safety. In this study, we examined the KS standard and the international standard (International Organization for Standardization, International Electrotechnical Commission, etc.) for the Medical Devices classified as grade 1 items and confirmed the International Organization for Standardization conformity of the KS standard by each item. The three methods are classified into the case where the KS matching standard of the item exists, the KS standard exists, and the KS standard does not exist but the international standard exists. The contents are scope, structure, test specification (tests on electrical and mechanical safety, tests on electromagnetic safety, tests on biological safety, tests on performance), and labeling. In order to establish validity of the standard specification, we requested the review of standards and specifications of each item through the meeting of industry - academy - medicine bottle experts' conferences such as hospitals, test inspection institutions, related companies and consumer organizations and two business briefings. Based on the opinions gathered, we have developed the Medical Devices classified as grade 1 standard specification by verifying and supplementing the details. The results of this research contribute to the presentation of quality management guidelines, prevention of misunderstanding between grades, and utilization of international harmonized standards.
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KEYWORD
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Medical Devices classified as grade 1, standards, enactment, revision
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