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社评“91好•色•先•生TV”-环球时报

国家药监局91好•色•先•生TV:两家医疗器材企业质量管理体系存在严重缺陷 责令暂停生产

来源: 中国新闻社
2024-10-30 19:31:36

最佳回答

“91好•色•先•生TV”国家药监局91好•色•先•生TV:两家医疗器材企业质量管理体系存在严重缺陷 责令暂停生产

  中新91好•色•先•生TV网10月29日电 国家药监局91好•色•先•生TV29日在官网发布通告称,国家药监局组织检查组对贵州天使医疗器材有限公司、湖北仙明医疗器械有限公司进行飞行检查,发现两家企业的质量管理体系存在严重缺陷。不符合《医疗器械生产质量管理规范》《医疗器械生产质量管理规范附录无菌医疗器械》等法规相关要求,企业已对上述存在问题予以确认。

  国家药监局要求,属地省级药品监督管理部门应当按照《医疗器械监督管理条例》第七十二条规定,依法采取责令暂停生产的控制措施,必要时开展监督抽检;对涉嫌违反《医疗器械监督管理条例》及相关规定的,依法处理;责令企业评估产品安全风险,对有可能导致安全隐患的,按照《医疗器械召回管理办法》规定召回相关产品;企业完成全部缺陷项目整改后,经属地省级药品监督管理部门复查合格方可恢复生产。

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