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医疗器械不良事件监测和再评价管理办法(1-2)-EN

医疗器械不良事件监测和再评价管理办法

Provisions for Medical Device Adverse Event Monitoring and Re-Evaluation


第一章 总 则

Chapter I General Provisions


  第一条 为加强医疗器械不良事件监测和再评价,及时、有效控制医疗器械上市后风险,保障人体健康和生命安全,根据《医疗器械监督管理条例》,制定本办法。

Article 1 In order to strengthen the monitoring and re-evaluation of medical device adverse events, timely and effectively control the post-marketing risks of medical devices, and ensure health and safety of people, the Provisions are formulated in accordance with the Regulations for the Supervision and Administration of Medical Devices.


  第二条 在中华人民共和国境内开展医疗器械不良事件监测、再评价及其监督管理,适用本办法。

Article 2 The Provisions are applicable to the monitoring, re-evaluation and supervision of medical device adverse events in the territory of the People's Republic of China.

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