日本兽医器械行业监管体系与启示  

Review on the Monitoring System of Japanese Veterinary Device Industry

作　　者：于遵波[1] 赵琪[1] 张晶声[1] 金闻名[1] 门立强[1] 夏兆飞[2] 李建波[1] 张存帅[1] Yu Zunbo;Zhao Qi;Zhang Jingsheng;Jin Wenming;Men Liqiang;Xia Zhaofei;Li Jianbo;Zhang Cunshuai(China Institute of Veterinary Drug Control,Beijing 100081,China;College of Veterinary Medicine,China Agricultural University,Beijing 100193,China)

机构地区：[1]中国兽医药品监察所,北京100081 [2]中国农业大学动物医学院,北京100193

出　　处：《中国动物检疫》2024年第9期54-58,共5页China Animal Health Inspection

摘　　要：日本医疗器械包括兽医器械尤其高尖端医疗器械在国际市场上占据明显的领先地位而其科学的监管模式对此起到了至关重要的作用。本文从《药品与医疗器械法》在日本法律体系中的位置、兽医器械的定义与分类,以及政府监管体系、相关法规主要规定等4个方面进行分析探讨,较为详细地概述了日本兽医器械行业监管体系状况,以期为我国兽医器械立法工作提供借鉴。In Japan,medical devices(including those for veterinary industry),especially the highly sophisticated ones,have led international markets,which was benefited by the scientific monitoring system implemented in the country.In the paper,the role of Drugs and Medical Devices Act in Japanese legal system,definition and classification of veterinary devices,as well as government monitoring system and main requirements defined by relevant laws and regulations were analyzed and discussed,and the monitoring system of Japanese veterinary device industry was reviewed,with a view to providing a reference for the legislation of veterinary devices in China.

关 键 词：兽医器械 日本 监管体系 

分 类 号：S852.23[农业科学—基础兽医学]