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KMID : 1094020180350010001
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Journal of Veterinary Clinics
2018 Volume.35 No. 1 p.1 ~ p.6
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Review of Regulatory Management System on Side Effects for Veterinary Medical Devices in Korea
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Kang Kyoung-Mook
Park Hee-Myung
Lee Chang-Min
Kang Min-Hee
Suh Tae-Young
Kang Hwan-Goo
Moon Jin-San
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Abstract
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This study reviewed the regulatory safety management system for prevention of side effects of veterinary medical devices in Korea based on data obtained through analyses of those medical devices. In order to ensure the safety of medical devices, Ministry of Food and Drug Safety has established the management system include licensing, test inspection (134 designated clinical trial agencies) and post management. In addition, it was introduce the good manufacture practice (GMP) certification system and device tracking requirements. In contrast, it is necessary to establish regulations for side effects report and awareness on veterinary medical devices in Korea. The center for veterinary medicine of FDA in the United States has been operated side effects reporting system of veterinary medical devices from user, manufactures and distributor. Due to increase the use of various kinds of veterinary medical devices for animals, it should be required to improve regulation related to the licensing procedures, GMP system, and the side effects reporting system in our country.
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KEYWORD
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veterinary medical devices, side effects, management system
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