摘要
本文结合我国和欧美等国家对医疗器械安全管理的法规和技术要求,从医疗器械的注册审批、生产质量管理体系和临床使用管理等方面进行阐述,探讨医疗器械安全管理法规在临床使用管理中的应用。
This paper introduces safety management regulations and technical requirements of medical devices in China, Europe and the United States,and describes the requirements of registration approval, production quality management system and clinical use of medical devices to explore the safety management regulations use in clinical management of medical devices.
出处
《中国医疗设备》
2010年第10期91-93,共3页
China Medical Devices
关键词
医疗器械
安全风险
管理规范
medical devices
security risk
management regulation
