【摘要】 兽医器械在动物疫病防治中起着至关重要的作用，国际上对兽医器械的监管主要有美国模式和欧盟模式，本文以典型国家为例剖析了其法律设定和运行机制，介绍了国际医疗器械监管机构论坛（IMDRF）的工作机制，以及其指南文件对各国兽医器械规则的指导作用。更多还原

【Abstract】 Veterinary devices play a crucial role in the prevention and control of animal diseases. International regulation of these devices primarily follows the U. S. model and the EU model. This paper analyzes the legislative frameworks and operational mechanisms of representative countries, introduces the working mechanisms of the International Medical Device Regulators Forum(IMDRF), and discusses how IMDRF guidance documents influence national regulations for veterinary devices.更多还原