【CODEX】医疗器械不良事件监测和再评价管理办法（3）-EN

第三章 报告与评价

Chapter III Reporting and Evaluation

第一节 基本要求

Section I Basic Requirements

第十七条 报告医疗器械不良事件应当遵循可疑即报的原则，即怀疑某事件为医疗器械不良事件时，均可以作为医疗器械不良事件进行报告。

Article 17 The reporting of medical device adverse event shall adhere to the principle of “when in doubt-report”, that is, an event can be reported as a medical device adverse event once it is suspected to be so.

　　报告内容应当真实、完整、准确。

The reported information shall be true, complete and accurate.

第十八条 导致或者可能导致严重伤害或者死亡的可疑医疗器械不良事件应当报告；创新医疗器械在首个注册周期内，应当报告该产品的所有医疗器械不良事件。

Article 18 Suspicious medical device adverse events that cause or may cause serious injury or death shall be reported; for innovative medical devices, all medical device adverse events of the product during the first registration period shall be reported.