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KMID : 0359320170570020071
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Korean Journal of Veterinary Research
2017 Volume.57 No. 2 p.71 ~ p.78
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Review of regulatory management on standards and specifications for veterinary medical devices in Korea
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Kang Kyoung-Mook
Kim Tae-Won
Kwon Oh-Ryun
Park Hea-Jung
Cho Soo-Min
Kim Chung-Hyun
Lee Myoung-Heon
Moon Jin-San
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Abstract
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Well-established standards and specifications for medical devices not only provide clarity and consistency in licensing processes but also secure device safety and effectiveness. This study reviewed regulatory standards and specifications for veterinary medical devices in Korea based on data obtained through analyses of those medical devices. General standards for electromechanical, electromagnetic, and biological safety and individual standards for 76 electric and 70 general medical device products have been established by the Korean Ministry of Food and Drug Safety. However, the first standards and specifications for veterinary medical devices were established in March 2000 for two products (disposable needle and syringe). Similar to the large number of standards for medical devices, there have been general standards for safety and individual standards for 72 veterinary medical devices (27 electric medical devices, 12 non-electric medical devices, 10 medical supplies, and 23 other types) established since 2014. These new standards considered, among other aspects, the devices’ applications, usage characteristics, and industrial environment. To date, the establishment of standards and specifications for veterinary medical devices remains limited. This study suggests that improvements should be made to the regulation of general and individual standards associated with various veterinary medical instruments, supplies, and in vitro diagnostic medical reagents.
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KEYWORD
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regulation, standards and specifications, veterinary medical devices
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