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医疗器械不良事件监测和再评价管理办法(4-6)-EN

第四章 重点监测

Chapter IV Intensive Monitoring


第四十二条 省级以上药品监督管理部门可以组织开展医疗器械重点监测,强化医疗器械产品上市后风险研究。

Article 42 The drug regulatory authority at or above the provincial level may organize the intensive monitoring of medical devices and strengthen the post-marketing risk study of medical device products.


第四十三条 国家药品监督管理局会同国务院卫生行政部门确定医疗器械重点监测品种,组织制定重点监测工作方案,并监督实施。

Article 43 The State Drug Administration shall, in conjunction with the health administrative department of the State Council, determine the medical device intensive monitoring types, organize the formulation of intensive monitoring work plans, and supervise their implementation.

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