警戒和上市后监督体系的目标是通过减少同种类型的医疗器械不良事件在不同地点不同时间的重复发生来增进对患者、使用者和其他人员的健康和安全性保护。本文介绍了第二工作组的任务和使命是:针对普通医疗器械警戒体系制定要求并提供国际协议来定义和协助警戒信息在国际上的流通,并促进此进程;阐述上市后监督的定义和指南。 The goal of the surveillance and post-market surveillance system is to enhance the health and safety of patients, users and others by reducing the recurrence of medical device adverse events of the same type at different locations and at different times. This paper describes the mission and mission of Working Group 2 as follows: Defining and assisting in the international circulation of warning messages and promoting the process by setting requirements and providing international agreements for the general medical device alert system; elaborating the definition and guidelines for post-market surveillance .