| Review of regulatory management on standards and specifications for veterinary medical devices in Korea |
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Kyoung-Mook Kang1, Tae-Won Kim2, Oh-Ryun Kwon2, Hea-Jung Park1, Soo-Min Cho1, Chung-Hyun Kim1, Myoung-Heon Lee1, Jin-San Moon1 |
1Veterinary Pharmaceutical Management Division, Animal and Quarantine Agency
2Korea Testing Certification |
| 동물용 의료기기 기준규격에 대한 고찰 |
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강경묵1, 김태원2, 권오륜2, 박혜정1, 조수민1, 김충현1, 이명헌1, 문진산1 |
1농림축산검역본부 동물약품관리과
2한국기계전기전자시험연구원 |
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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. |
| Key Words:
regulation, standards and specifications, veterinary medical devices |
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