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Announcement of the Ministry of Commerce, the General Administration of Customs and the National Medical Products Administration on Conducting the Export of Medical Supplies in an Orderly Manner [Effective]
商务部、海关总署、国家药品监督管理局关于有序开展医疗物资出口的公告 [现行有效]
【法宝引证码】

Announcement of the Ministry of Commerce, the General Administration of Customs and the National Medical Products Administration on Conducting the Export of Medical Supplies in an Orderly Manner 

商务部、海关总署、国家药品监督管理局关于有序开展医疗物资出口的公告

(Announcement No. 5 [2020] of the Ministry of Commerce, the General Administration of Customs and the National Medical Products Administration) (商务部、海关总署、国家药品监督管理局公告2020年第5号)

As the global coronavirus pandemic accelerates, the orderly export of medical supplies based on the effective containment of domestic outbreaks is an important measure for deepening international cooperation in epidemic prevention and control and jointly responding to the global public health crisis. During the special period of prevention and control of outbreaks, for the purposes of effectively supporting the global combat against the pandemic, ensuring product quality safety, and regulating export order, beginning on April 1, the enterprises that export novel coronavirus testing reagents, medical masks, medical protective suits, ventilators, and infrared thermometers should, when declaring to the Customs, provide written or electronic statements (see Annex 1 for the template), and undertake that they have obtained China's medical device product registration certificates (see Annex 2 for relevant registration information) for the exports and the exports meet the requirements of quality standards of the importing countries (regions). The Customs should check and release products based on the medical device product registration certificates granted by the medical products administrations. The regulatory measures for the quality of exports of the aforementioned medical supplies will be adjusted dynamically in light of the developments of the pandemic.
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 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。
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