医械临床试验机构门槛明确

2017-11-27 刘志勇健康报

近日，国家食品药品监督管理总局、国家卫生计生委联合发布《医疗器械临床试验机构条件和备案管理办法》，明确了医疗器械临床试验机构应当具备的条件，包括具有二级甲等以上机构资质以及设置专门的临床试验管理部门、人员、管理体系等

近日，国家食品药品监督管理总局、国家卫生计生委联合发布《医疗器械临床试验机构条件和备案管理办法》，明确了医疗器械临床试验机构应当具备的条件，包括具有二级甲等以上机构资质以及设置专门的临床试验管理部门、人员、管理体系等。对列入需进行临床试验审批目录的第三类医疗器械产品，应在三级甲等医疗机构专业范围内开展临床试验；开展创新医疗器械产品或需进行临床试验审批的第三类医疗器械产品临床试验的主要研究者，应具有高级技术职称并参加过3个以上医疗器械或药物临床试验。

《办法》明确，由食品药品监管总局组织建立医疗器械临床试验机构备案管理信息系统，用于临床试验机构登记备案、备案管理和供各方查询。省级以上食药监管部门和卫生计生行政部门，按照分工负责组织开展对临床试验机构的监督管理和信息沟通等监管职责。

国家食药监管总局明确，《办法》适用于在我国境内开展医疗器械（含按照医疗器械管理的体外诊断试剂产品）临床试验的机构备案管理工作，包括开展临床试验的血液中心和中心血站、设区的市级以上疾病预防控制中心、戒毒中心等非医疗机构。《办法》的颁布实施，将鼓励经评估符合条件的更多医疗机构参与医疗器械临床试验，有利于释放临床资源，扩大临床试验机构的数量，更好地满足医疗器械临床试验的需求，对鼓励医疗器械产品创新、促进医疗器械产业健康发展具有重要意义。

《办法》施行后，医疗器械临床试验机构可登录国家食药监管总局网站，在“医疗器械临床试验机构备案管理信息系统”中进行备案。有关单位和个人可通过“医疗器械临床试验机构备案管理信息系统”查询医疗器械临床试验机构备案信息。该《办法》自2018年1月1日起施行。

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2017-12-02 1e131c8cm23(暂无匿称)

学习学习学习学习学习!

71 0
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2017-12-01 lofter

学习了感谢分享

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2017-12-01 1e131c8cm23(暂无匿称)

学习学习学习学习学习!

75 0
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2017-11-30 1e131c8cm23(暂无匿称)

学习学习学习学习学习!

73 0
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2017-11-29 lyh994

时间过得飞快

80 0
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2017-11-29 1e131c8cm23(暂无匿称)

学习了学习了再学习了!

43 0
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2017-11-28 yfjms

学习

115 0
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2017-11-28 明月清辉

谢谢分享.学习了

61 0
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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=264981, encodeId=4cc926498135, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=115, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3da1990174, createdName=yfjms, createdTime=Tue Nov 28 08:21:23 CST 2017, time=2017-11-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=264947, encodeId=fde526494e98, content=谢谢分享.学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Tue Nov 28 07:12:12 CST 2017, time=2017-11-28, status=1, ipAttribution=), 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2017-11-28 执着追梦

学习.谢谢分享

62 0
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2017-11-28 183****7028

学习

62 0