Performance assessment and improvement plan of the regulatory management system of veterinary medical devices in Korea.
10.14405/kjvr.2015.55.2.97
- Author:
Hyo Jin AN
1
;
Hyang Jin YOON
;
Chung Hyun KIM
;
Sung Hwan WEE
;
Jin San MOON
Author Information
1. Division of Veterinary Veterinary Pharmaceutical Management, Animal and Plant Quarantine Agency, Anyang 430-757, Korea. moonjs727@korea.kr
- Publication Type:In Vitro ; Original Article
- Keywords:
medical devices;
veterinary medical devices;
regulatory management system
- MeSH:
Agriculture;
Animals;
Certification;
Classification;
Equipment and Supplies;
Indicators and Reagents;
Insemination, Artificial;
Japan;
Korea;
Plants;
Quarantine;
Reagent Kits, Diagnostic
- From:Korean Journal of Veterinary Research
2015;55(2):97-103
- CountryRepublic of Korea
- Language:Korean
-
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.
