Performance assessment and improvement plan of the regulatory management system of veterinary medical devices in Korea |
An, Hyo-Jin
(Division of Veterinary Veterinary Pharmaceutical Management, Animal and Plant Quarantine Agency)
Yoon, Hyang-Jin (Division of Veterinary Veterinary Pharmaceutical Management, Animal and Plant Quarantine Agency) Kim, Chung-Hyun (Division of Veterinary Veterinary Pharmaceutical Management, Animal and Plant Quarantine Agency) Wee, Sung-Hwan (Division of Veterinary Veterinary Pharmaceutical Management, Animal and Plant Quarantine Agency) Moon, Jin-San (Division of Veterinary Veterinary Pharmaceutical Management, Animal and Plant Quarantine Agency) |
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3 | Animal and Plant Quarantine Agency (KR). Official Compendium of Veterinary Medicines. Notice 2013-41 (Mar. 22, 2013). |
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6 | Animal and Plant Quarantine Agency (KR). The Provisions Relating to Evaluation for Safety and Effectiveness of Veterinary Medicines etc. Notice 2014-2 (Jan. 8, 2014). |
7 | Federal Food, Drug, and Cosmetic Act (FD&C Act) of 2010, Pub. L. No. 75-717 (Jan. 5, 2010). |
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11 | Ministry of Agriculture, Food and Rural Affairs (KR). Handling Rules of Animal Medicines etc. Enforcement Ordinance 129 (Jan. 6, 2015). |
12 | Ministry of Food and Drugs Safety (KR). Enforcement Decree of the Medical Device Act. Presidential Decree 25357 (Aug. 7, 2014). |
13 | Ministry of Health and Welfare (KR). Pharmaceutical Affairs Act No. 13219. Enforcement Ordinance (Mar. 15, 2015). |
14 | Ministry of Food and Drugs Safety (KR). Enforcement Regulations of the Medical Device Act. Ordinance of the Prime Minister 1081 (Aug. 7, 2014). |
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17 | Ministry of Food and Drugs Safety (KR). Regulation on Approval, Notification, Audit and etc. of Medical Device. Notice 2014-178 (Oct. 31, 2014). |