Journal of Veterinary Clinics (한국임상수의학회지)

The Korean Society of Veterinary Clinics (한국임상수의학회)
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Review of Regulatory Management System on Side Effects for Veterinary Medical Devices in Korea

국내 동물용의료기기 부작용 관리시스템에 대한 고찰

  • Kang, Kyoung-Mook (Veterinary Pharmaceutical Management Division, Animal and Plant Quarantine Agency) ;
  • Park, Hee-Myung (Department of Veterinary Internal Medicine, College of Veterinary Medicine, Konkuk University) ;
  • Lee, Chang-Min (Department of Veterinary Internal Medicine, College of Veterinary Medicine, Konkuk University) ;
  • Kang, Min-Hee (Department of Veterinary Internal Medicine, College of Veterinary Medicine, Konkuk University) ;
  • Suh, Tae-Young (Veterinary Pharmaceutical Management Division, Animal and Plant Quarantine Agency) ;
  • Kang, Hwan-Goo (Veterinary Pharmaceutical Management Division, Animal and Plant Quarantine Agency) ;
  • Moon, Jin-San (Veterinary Pharmaceutical Management Division, Animal and Plant Quarantine Agency)
  • 강경묵 (농림축산검역본부 동물약품관리과) ;
  • 박희명 (건국대학교 수의과대학) ;
  • 이창민 (건국대학교 수의과대학) ;
  • 강민희 (건국대학교 수의과대학) ;
  • 서태영 (농림축산검역본부 동물약품관리과) ;
  • 강환구 (농림축산검역본부 동물약품관리과) ;
  • 문진산 (농림축산검역본부 동물약품관리과)
  • Received : 2018.01.10
  • Accepted : 2018.02.21
  • Published : 2018.02.28
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Abstract

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.

Keywords

References

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