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陕西省医疗器械质量监督检验院 >> 信息动态 >> 政策法规 >> 正文 365bet官方博客_365bet线上棋牌_365bet体育开户网址
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陕西省医疗器械质量监督检验院 >>365bet体育开户网址 >> 正文
医疗器械不良事件监测的主要目的和意义
作者: 信息来源:转载自国家局网站 点击数:2101 更新时间:2015/11/26 10:14:00

  医疗器械不良事件监测旨在通过对医疗器械使用过程中出现的可疑不良事件进行收集、报告、分析和评价,发现和识别上市后医疗器械存在的不合理风险,对存在安全隐患的医疗器械采取有效的控制措施,提高产品的安全性,防止伤害事件的重复发生和蔓延,从而保障公众用械安全。

  

365bet体育开户网址  通过对医疗器械不良事件的监测和评价,可以为医疗器械监督管理部门提供监管依据;通过采取相应的监管措施,可以减少或者避免同类医疗器械不良事件的重复发生,促进医务人员科学、合理用械,规范医疗操作行为,降低患者、医务人员和其他人员使用医疗器械而造成伤害的风险,有效保障广大人民群众用械安全;可以进一步提高对医疗器械性能和功能的要求,提高医疗器械相关标准,推进企业对新产品的研制和推广,有利于促进我国医疗器械产业的持续、健康发展。

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