网售医疗器械有了监管办法

2017-12-29 刘志勇健康报

近日，国家食品药品监督管理总局发布《医疗器械网络销售监督管理办法》，明确坚持线上线下一致的监管原则，要求从事网络销售的医疗器械生产经营企业和上市许可持有人，其销售条件应符合《医疗器械监督管理条例》和该《办法》的规定；网络交易服务第三方平台提供者应审核确认在其平台入驻的企业具备线下实体店。

近日，国家食品药品监督管理总局发布《医疗器械网络销售监督管理办法》，明确坚持线上线下一致的监管原则，要求从事网络销售的医疗器械生产经营企业和上市许可持有人，其销售条件应符合《医疗器械监督管理条例》和该《办法》的规定；网络交易服务第三方平台提供者应审核确认在其平台入驻的企业具备线下实体店。《办法》将自2018年3月1日起施行。

该《办法》要求，网络销售企业和网络交易服务第三方平台提供者应分别向市级和省级食药监管部门备案。第三方平台提供者应建立平台入驻企业核实登记、质量安全监测等管理制度，对违法经营者和违法产品立即停止网络交易服务并报告。

《办法》明确，第三方平台提供者统一由省级食药监管部门负责监管。对不按规定建立并执行相关质量管理制度，存在质量安全隐患的，监管部门可责令暂停网络销售者暂停提供相关网络交易服务。

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2018-01-01 jihuaijun1112

学习学习学习

61 0
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2017-12-31 wwzzly

#监管#

35 0
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2017-12-30 1e1b8538m79(暂无匿称)

不错的文章.值得一看

66 0
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2017-12-30 hhh678

henhao

61 0
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2017-12-30 清风拂面

很好.谢谢分享

64 0

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