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KMID : 0380420160400040179
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Journal of Prventive Veterinary Medicine
2016 Volume.40 No. 4 p.179 ~ p.184
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A review of regulatory management on classification system and scope of veterinary medical devices in Korea
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Kim Min-Do
Yoon Hyang-Jin
An Hyo-Jin
Kim Chung-Hyun
Wee Sung-Hwan
Moon Jin-San
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Abstract
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The purpose of this study was to review regulatory management of the classification system and scope of veterinary medical devices in Korea. In Korea, the four categories of the classification system for veterinary medical devices (instruments, supplies, artificial insemination apparatus, and others) is somewhat differently than that for human medical devices (instruments, supplies, dental materials, and reagents for in vitro diagnostics). In 2013, veterinary medical devices were classified into approximately 1,400 items, whereas, human medical devices were classified into approximately 2,200 items. Dissimilar to human medical devices, veterinary medical devices have no individual identification codes for effective market management. In conclusion, it is necessary to introduce a device identification code system and re-examine scope of the classification system for veterinary medical devices in Korea.
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KEYWORD
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Veterinary medical devices, scope, classification system
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