医疗器械不良事件监测-现状与展望  

Medical Devices' Adverse Events' Monitoring ?the Present and the Future

作　　者：王兰明[1] 

机构地区：[1]国家食品药品监督管理局医疗器械司,北京100810

出　　处：《中国医疗器械杂志》2004年第4期282-289,共8页Chinese Journal of Medical Instrumentation

摘　　要：介绍医疗器械不良事件的基本概念,论述美国、欧盟、日本和有关国际组织关于医疗器械不良事件监测的管理规定,并回顾和展望我国在该领域的相关工作。Some concepts related to the medical devices adverse events monitoring, and the laws and administrative regulations in the US, EU, Japan and some international organizations are introduced in the paper. Some works and efforts we have done in the past and what should be done in the near future in China are also outlined.

关 键 词：医疗器械 不良事件 监测 上市后监督 

分 类 号：F713.56[经济管理—市场营销]