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【CODEX】医疗器械不良事件监测和再评价管理办法(7-9)-EN

第七章 监督管理

Chapter VII Supervision and Administration


第六十三条 药品监督管理部门应当依据职责对持有人和经营企业开展医疗器械不良事件监测和再评价工作情况进行监督检查,会同同级卫生行政部门对医疗器械使用单位开展医疗器械不良事件监测情况进行监督检查。

Article 63 The drug regulatory authority shall supervise and inspect the monitoring and re-evaluation of the medical device adverse events on the holders and the distributing enterprises in accordance with their duties, and conduct supervision and inspection with the health administrative department at the same level on the medical device adverse events monitoring conducted by the medical device using units in conjunction.


第六十四条 省、自治区、直辖市药品监督管理部门应当制定本行政区域的医疗器械不良事件监测监督检查计划,确定检查重点,并监督实施。

Article 64 The drug regulatory authority of a province, autonomous region or municipality directly under the Central Government shall formulate a supervision and inspection plan for the monitoring of medical device adverse events in its administrative region, determine the inspection focus, and supervise its implementation.

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