Korean Journal of Veterinary Research (대한수의학회지)

The Korean Society of Veterinary Science (대한수의학회)
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Review of regulatory management on standards and specifications for veterinary medical devices in Korea

동물용 의료기기 기준규격에 대한 고찰

  • Kang, Kyoung-Mook (Veterinary Pharmaceutical Management Division, Animal and Quarantine Agency) ;
  • Kim, Tae-Won (Korea Testing Certification) ;
  • Kwon, Oh-Ryun (Korea Testing Certification) ;
  • Park, Hea-Jung (Veterinary Pharmaceutical Management Division, Animal and Quarantine Agency) ;
  • Cho, Soo-Min (Veterinary Pharmaceutical Management Division, Animal and Quarantine Agency) ;
  • Kim, Chung-Hyun (Veterinary Pharmaceutical Management Division, Animal and Quarantine Agency) ;
  • Lee, Myoung-Heon (Veterinary Pharmaceutical Management Division, Animal and Quarantine Agency) ;
  • Moon, Jin-San (Veterinary Pharmaceutical Management Division, Animal and Quarantine Agency)
  • 강경묵 (농림축산검역본부 동물약품관리과) ;
  • 김태원 (한국기계전기전자시험연구원) ;
  • 권오륜 (한국기계전기전자시험연구원) ;
  • 박혜정 (농림축산검역본부 동물약품관리과) ;
  • 조수민 (농림축산검역본부 동물약품관리과) ;
  • 김충현 (농림축산검역본부 동물약품관리과) ;
  • 이명헌 (농림축산검역본부 동물약품관리과) ;
  • 문진산 (농림축산검역본부 동물약품관리과)
  • Received : 2017.03.23
  • Accepted : 2017.05.16
  • Published : 2017.06.30
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Abstract

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.

Keywords

References

  1. An HJ, Yoon HJ, Kim CH, Wee SH, Moon JS. Performance assessment and improvement plan of the regulatory management system of veterinary medical devices in Korea. Korea J Vet Res 2015, 55, 97-103. https://doi.org/10.14405/kjvr.2015.55.2.97
  2. An HJ, Kim CH, Yoon HJ, Wee SH, Moon JS. Performance evaluation of registration and sales of veterinary medical devices in Korea. J Vet Clin 2015, 32, 85-90.
  3. Animal and Plant Quarantine Agency (KR). Regulations on the Approval of Veterinary Medical Devices. Notice 2015-20 (Aug. 21, 2015).
  4. Animal and Plant Quarantine Agency (KR). Regulations on the Scope and Designation of Veterinary Medical Devices. Notice 2015-23 (Aug. 21, 2015).
  5. Animal and Plant Quarantine Agency (KR). Standards and Specifications for Veterinary Medical Devices. Notice 2015-7 (Apr. 9, 2015).
  6. Clarkson DM. Medical Device Guidebook: a browser information resource for medical device users. Med Eng Phys 2017, 41, 97-102.
  7. Flack M, Reed T, Crowley J, Gardner S. Identifying, understanding, and communicating medical device use errors: observations from an FDA pilot program. In: Henriksen K, Battles JB, Marks ES, Lewin DI (eds.). Advances in Patient Safety: From Research to Implementation Vol. 3. Agency for Healthcare Research and Quality, Rockville, 2005.
  8. Food and Drug Administration (US). FDA Compliance Policy Guides. CPG Sec. 607.100 - Adequate Directions for Use (Species Designation) - Animal Drugs and Veterinary Devices. Silver Spring, 2013.
  9. Food and Drug Administration (US). How FDA Regulates Veterinary Devices. Silver Spring, 2016.
  10. IEC. IEC 60601-1:2005. Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. 3rd ed. International Electrotechnical Commission, Geneva, 2012.
  11. IEC. IEC 62304:2006. Medical device software-Software life cycle processes. 1st ed. International Electrotechnical Commission, Geneva, 2006.
  12. IEC. IEC 62366-1:2015. Medical devices-Part 1: Application of usability engineering to medical devices. International Electrotechnical Commission, Geneva, 2015.
  13. ISO. ISO 10993-1:2009. Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process. International Organization for Standardization, Geneva, 2009.
  14. ISO. ISO 13485:2016. Medical devices-Quality management systems-Requirements for regulatory purposes. International Organization for Standardization, Geneva, 2016.
  15. ISO. ISO 14971:2007. Medical devices-Application of risk management to medical devices. International Organization for Standardization, Geneva, 2007.
  16. JVPA. Veterinary Medical Device Handbook. pp. 6-17, Japan Veterinary Products Association, Tokyo, 2013.
  17. Kim DY, Lee HS, Kang BS, Park HJ, Kim S, Kwon TH, Cha JH, Lee JW, Oh HJ. A study on the development of test method for risk management of medical electrical devices in IEC 60601-3(3rd). Regul Res Food Drug Cosmet 2013, 8, 53-67.
  18. Kim MD, Yoon HJ, An HJ, Kim CH, Wee SH, Moon JS. A review of regulatory management on classification system and scope of veterinary medical devices in Korea. J Prev Vet Med 2016, 40, 179-184. https://doi.org/10.13041/jpvm.2016.40.4.179
  19. Ministry of Food and Drugs Safety (KR). Medical Appliances Act No. 13116 (Dec. 30, 2016).
  20. Ministry of Food and Drugs Safety (KR). Regulation on Grade of Medical Device Item and by Item. Notice 2017-6 (Jan. 24, 2017).
  21. Ministry of Food and Drugs Safety (KR). Standards and Specifications for Veterinary Medical Devices. Notice 2014-155 (Sep. 5, 2014).
  22. Ministry of Food and Drugs Safety (KR). Standards and Specifications for Veterinary Medical Devices. Notice 2016-90 (Aug. 26, 2016).