국내 동물용의료기기 부작용 관리시스템에 대한 고찰

= Review of Regulatory Management System on Side Effects for Veterinary Medical Devices in Korea

• 저자[authors] 강경묵(Kyoung-Mook Kang),박희명(Hee-Myung Park),이창민(Chang-Min Lee),강민희(Min-Hee Kang),서태영(Tae-Young Suh),강환구(Hwan-Goo Kang),문진산(Jin-San Moon)
  

• 학술지명[periodical name] 한국임상수의학회지
  

• 권호사항[Volume/Issue] Vol.35No.1[2018]
  

• 발행처[publisher] 한국임상수의학회
  

• 자료유형[Document Type] 학술저널
  

• 수록면[Pagination] 1-6
  

• 언어[language] Korean
  

• 발행년[Publication Year] 2018
  

• 주제어[descriptor] veterinary medical devices,side effects,management system
  

초록[abstracts]

[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.]

목차[Table of content] Abstract]

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