商务部海关总署国家药监局关于有序开展医疗物资出口的公告20200331
当前，全球疫情呈加速扩散蔓延态势。在做好自身疫情防控的基础上，有序开展医疗物资出口是深化疫情防控国际合作、共同应对全球公共卫生危机的重要举措。在疫情防控特殊时期，为有效支持全球抗击疫情，保证产品质量安全、规范出口秩序，自4月1日起，出口新型冠状病毒检测试剂、医用口罩、医用防护服、呼吸机、红外体温计的企业向海关报关时，须提供书面或电子声明（模版见附件1），承诺出口产品已取得我国医疗器械产品注册证书（相关注册信息见附件2），符合进口国（地区）的质量标准要求。海关凭药品监督管理部门批准的医疗器械产品注册证书验放。上述医疗物资出口质量监管措施将视疫情发展情况动态调整。
有关医疗物资出口企业要确保产品质量安全、符合相关标准要求，积极支持国际社会共同抗击疫情。
附件：1.出口医疗物资声明模版
2.我国相关医疗器械产品注册信息（国家药监局网站www.nmpa.gov.cn动态更新）
商务部 海关总署 国家药品监督管理局
2020年 3月31日
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