Korean J Vet Res.  2015 Jun;55(2):97-103. 10.14405/kjvr.2015.55.2.97.

Performance assessment and improvement plan of the regulatory management system of veterinary medical devices in Korea

• An HJ
• Yoon HJ
• Kim CH
• Wee SH
• Moon JS

• KMID: 1807797
• DOI: http://doi.org/10.14405/kjvr.2015.55.2.97

Abstract

In this study, the Korean veterinary medical devices management system was evaluated relative to systems in the USA, EU, and Japan. Veterinary medical devices are regulated in Korea based on the Medical Appliance Act of 1997. This was initially supervised by the Ministry of Agriculture, Food and Rural Affairs and Korea Animal Health Products Association, and subsequently by the Animal and Plant Quarantine Agency (QIA) in 2000. These devices were classified approximately 1,400 categories as instruments, supplies, artificial insemination apparatus, and other categories. Each of these devices was assigned to four regulatory grades by the QIA in 2007. The ranking system for veterinary medical devices was implemented in 2014 with 820 products from 162 companies registered by that year. However, in vitro diagnostic devices (IVDDs) for animals were managed as medical devices and biological medicine. In vitro diagnostic reagents for treating infection diseases are not subjected to either a classification or grading system. Veterinary medical devices are currently exempt from good manufacturing practices (GMP) and device tracking requirements. Due to gradual growth of the domestic veterinary medical devices market since 2008, regulation of these devices should be improved with re-examination of IVDDs and GMP certification for the effective operating system.

Keyword

medical devices; veterinary medical devices; regulatory management system

MeSH Terms

Agriculture
Animals
Certification
Classification
Equipment and Supplies
Indicators and Reagents
Insemination, Artificial
Japan
Korea
Plants
Quarantine
Reagent Kits, Diagnostic
Indicators and Reagents
Reagent Kits, Diagnostic