医疗器械网络销售监督管理办法20171222
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2017年12月22日 发布 |
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近日，国家食品药品监督管理总局以总局令第38号发布《医疗器械网络销售监督管理办法》（以下简称《办法》），自2018年3月1日起施行。 《办法》坚持线上线下一致的原则，明确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，其销售条件应当符合《医疗器械监督管理条例》和《办法》的要求；网络交易服务第三方平台提供者应当审核确认在其平台入驻的企业具备线下实体店。 《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分别向市局和省局备案，并进一步细化了网络销售企业和网络交易服务第三方平台提供者的义务，规定网络销售企业应当保证医疗器械质量安全；第三方平台提供者应当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；网络销售企业和第三方平台提供者应当保障销售交易数据和资料真实、完整、可追溯。 《办法》明确第三方平台提供者统一由省级食品药品监督管理部门负责监管。针对网络销售跨地域、质量问题波及面广的特点，《办法》细化不同网络违法情形的查处职责，形成违法企业所在地、违法行为发生地以及违法行为结果地各级监管部门的联动配合；后果特别严重的违法行为可报请总局协调或者由总局组织直接查处。《办法》规定，总局建立国家级网络交易监测平台，定期向省局通报监测情况；各地监管情况定期向总局报告，并依法向社会公开。 《办法》强化风险控制，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，监管部门可以责令暂停网络销售或者暂停提供相关网络交易服务。对存在质量安全问题的，食品药品监管部门可对第三方平台提供者、网络销售企业的法定代表人或者主要负责人进行约谈。拒不执行暂停网络销售决定或者约谈后拒不按照要求整改的，网络销售企业、第三方平台提供者及其法定代表人或者主要责任人将被列入失信企业和失信人员名单，并向社会公开。 |
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