中国动物检疫2025，Vol.42Issue(11)：50-55,6.DOI:10.3969/j.issn.1005-944X.2025.11.009
澳大利亚兽医器械监管体系及特点分析
Analysis on Australia's Veterinary Device Regulatory System and Its Characteristics
摘要
Abstract
In order to improve veterinary device regulatory system as well as its legislative scientificity and regulatory performance in China,legal framework,classification standards,organization structuring and operational mechanisms of the veterinary device regulation in Australia were systematically analyzed.In Australia,veterinary devices were incorporated into a common management system for medical devices under the fundamental legal framework of the Therapeutic Goods Act,and regulated based on a risk-based classification system under a full-chain regulatory mechanism covering market access,manufacturing licensing,distribution,use and post-market monitoring.In conclusion,Australia's veterinary device regulatory system could ensure the safety and efficacy of veterinary devices,and meet the needs of animal health protection and industry development,providing valuable insights for the development of veterinary device legislation and the construction of a regulatory system in China.关键词
澳大利亚/兽医器械/监管体系/分类管理/兽医立法Key words
Australia/veterinary device/regulatory system/classification management/veterinary legislation分类
畜牧业引用本文复制引用
于遵波..澳大利亚兽医器械监管体系及特点分析[J].中国动物检疫,2025,42(11):50-55,6.基金项目
中国兽医药品监察所第三批"兽药行业公益性重点专项"(GY202409) （GY202409）
