医疗器械制造商或其授权代理商的不良事件报告指南

Adverse Event Reporting Guidance for the MedicalDevice Manufacturer or its Authorized Representative

不良事件报告及其后续评价的目的,是通过发布那些能够减少不良事件的发生、 防止不良事件的再现、减缓不良事件再现后果的信息,最终提高病人、使用者及其他人的健康和安全保证。本文介绍了不良事件的决策过程和不良事件报告的豁免原则,以及与使用错误相关的可报告性。

The objective of the adverse event reporting and subsequent evaluations is to improve protection of the health and safety of patients,users and others by disseminating information which may reduce the likelihood of,or prevent repetition of adverse events,or alleviate consequences of such repetition. In this article,the decision process of adverse events,the exemption rules of the reporting and the reportability involving use error will be introduced .