关键词: 医疗器械, 不良事件, 监测, 重新注册, 第一责任人, 安全

Abstract: Medical device adverse event monitoring and medical device anew registration are the two inseparable supervision section for before and after medical device launch. It is reaction each other and which is the inner request of risk management in its all life cycle. Medical device adverse event monitoring is very important to anew registration, which its aim to detect the potential risk of post-marketing and replenish the data which couldn't sufficiency supplied during prophase registration. Through anew registration we will refer adverse event evaluation reports and strengthen the responsibility consciousness of enterprise. It can improve the safety of anew registration medicals and distinct every departmental duties. As the same time it can promote the work of medical device adverse event monitoring and raise the safety of medical device.

Key words: medical device, adverse event, monitoring, anew registration, the primary responsible person, safety