美国对高风险医疗器械的审批  

USA Approval of High-risk Medical Device

作　　者：常永亨[1] 

机构地区：[1]中国医药国际交流中心,北京市100082

出　　处：《中国医疗器械杂志》2013年第2期132-136,共5页Chinese Journal of Medical Instrumentation

摘　　要：在各国对医疗器械进行监督管理的实践中,监管的严格程度和需要通过的法规程序是根据医疗器械的风险等级来确定的。该文简要介绍了美国对高风险医疗器械进入市场的法规要求。During the practice of supervision and management of medical device in different countrie, the strict regulatory and needs of the program by the regulations is to be determined by the risk level of the medical equipment. This paper briefly describes the regulatory requirements of the United States to enter the market for high-risk medical device.

关 键 词：医疗器械 法规 风险 上市前审批 

分 类 号：TH77[机械工程—仪器科学与技术]