摘要
医疗器械风险管理是保证医疗器械安全有效的一项重要管理活动,贯穿于医疗器械的全寿命过程,具有标准化的管理程序,其法规是进行风险管理的重要指南。文章探究了我国医疗器械风险管理的现状、不同责任主体的职责,并简要介绍了相关法规。
Risk management of medical device is an important management which insure it safety and effectiveness.It run through all the life of medical device and could implement the supervisory program standards,and the regulation as the fundamental directory for the risk management.This paper analyses the status quo of risk management in medical device include the responsibility of different body duty and relevant regulation.
出处
《中国药物警戒》
2010年第5期290-292,共3页
Chinese Journal of Pharmacovigilance
关键词
医疗器械
风险管理
法规
职责
medical device
risk management
regulation
responsibility
