(Received: April 14, 2015; Accepted: May 15, 2015)Abstract : In this study, the Korean veterinary medical devices management system was evaluated relative to systemsin the USA, EU, and Japan. Veterinary medical devices are regulated in Korea based on the Medical Appliance Actof 1997. This was initially supervised by the Ministry of Agriculture, Food and Rural Affairs and Korea Animal HealthProducts Association, and subsequently by the Animal and Plant Quarantine Agency (QIA) in 2000. These deviceswere classified approximately 1,400 categories as instruments, supplies, artificial insemination apparatus, and othercategories. Each of these devices was assigned to four regulatory grades by the QIA in 2007. The ranking systemfor veterinary medical devices was implemented in 2014 with 820 products from 162 companies registered by thatyear. However, in vitro diagnostic devices (IVDDs) for animals were managed as medical devices and biologicalmedicine. In vitro diagnostic reagents for treating infection diseases are not subjected to either a classification or gradingsystem. Veterinary medical devices are currently exempt from good manufacturing practices (GMP) and device trackingrequirements. Due to gradual growth of the domestic veterinary medical devices market since 2008, regulation of thesedevices should be improved with re-examination of IVDDs and GMP certification for the effective operating system.Keywords : medical devices, veterinary medical devices, regulatory management system