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【CODEX】2014 No.650 医疗器械监督管理条例(5-6)-EN

第五章不良事件的处理与医疗器械的召回

Chapter V Treatment of Adverse Event and Medical Device Recall

 

  第四十六条 国家建立医疗器械不良事件监测制度,对医疗器械不良事件及时进行收集、分析、 评价、控制。

Article 46. The state shall establish a medical device adverse event monitoring system, timely collect, analyze, evaluate, and control medical device adverse event.

 

  第四十七条 医疗器械生产经营企业、使用单位应当对所生产经营或者使用的医疗器械开展不良事件监测;发现医疗器械不良事件或者可疑不良事件,应当按照国务院食品药品监督管理部门的规定,向医疗器械不良事件监测技术机构报告。

Article 47. Medical device manufacturer, distributor and using unit shall conduct adverse event monitoring on their manufactured, distributed or used medical devices accordingly; if a medical device adverse event or suspected adverse event is found, it shall be reported to the medical device adverse event monitoring institution according to the related provisions of the food and drug regulatory authority under the State Council.

 

任何单位和个人发现医疗器械不良事件或者可疑不良事件,有权向食品药品监督管理部门或者医疗 器械不良事件监测技术机构报告。

Any units or individuals when find any adverse event or suspected adverse event have right to report it to the food and drug regulatory authority or to the medical device adverse event monitoring institution.


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