民用口罩出口报关资料

未获得药品监督管理部门的注册证书，但已获得国外相关标准认证，能否出口？
答：根据“5号公告”规定，出口相关医疗物资应取得我国医疗器械产品注册证书，符合进口国(地区)质量标准要求。针对已获得国外相关标准认证，但尚未取得我国医疗器械产品注册证书的情况，建议相关企业按规定向药品监督管理部门提出申请，及时获取注册证书。
Answer: according to the regulation of "announcement No.5", the export of relevant medical materials shall obtain the registration certificate of medical device products in China, which conforms to the quality standard requirements of the importing country (region). In view of the situation that the company has obtained the relevant foreign standard certification, but has not yet obtained the registration certificate of medical device products in China, it is suggested that the relevant enterprises apply to the drug supervision and administration department according to the regulations and obtain the registration certificate in time.

国家对出口医疗物资的管理还会有变化吗？
答：根据“5号公告”所述，为了**相关出口医疗物资的质量安全，商务部、海关总署、国家药品监督管理局将视疫情发展情况动态调整出口质量监管措施。请广大出口企业提前做好准备，确保产品质量安全。
A: according to announcement 5, in order to ensure the quality and safety of related exported medical materials, the Ministry of Commerce, the General Administration of customs and the State Drug Administration will dynamically adjust the export quality supervision measures according to the development of the epidemic situation. Please make preparations in advance for the export enterprises to ensure product quality and safety.

李国杰（经理）：18202125732  

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