出口醫療物資的通關手續有什么變化？

答：“5號公告”發布以后，企業申報出口公告范圍內的5類醫療物資時，在通關環節與之前相比需新增提交“醫療器械產品注冊證書”和“出口醫療物資聲明”，其中“醫療器械產品注冊證書”應與報關單申報信息一致。海關憑藥品監督管理部門批準的醫療器械產品注冊證書驗放相關出口醫療物資。“53號公告”發布以后， 有11類出口醫療物資需實施出口商品檢驗。此次新增實施出口商品檢驗的醫療物資不實施產地檢驗，申報時無需電子底賬。企業需在申報時注明是否醫用。其中，在“5號公告”范圍內的醫療物資，按照上述要求提交隨附單據。其他出口醫療物資，建議企業按照《醫療器械分類目錄》的管理類別，在向海關申報時，參照“5號公告”的要求，分別提供醫療器械產品注冊/備案證明，以及質量安全聲明。

Answer: "after announcement 5" is issued, when enterprises declare 5 types of medical materials within the scope of export announcement, they need to b "medical device product registration certificate" and "export medical material declaration" in the customs bance b compared with the previous one. Among them, "medical device product registration certificate" should be consistent with the declaration inbation of the customs declaration. The customs shall examine and release the relevant exported medical materials with the registration certificate of medical devices approved by the drug regulatory department. After the Announcement No. 53 was issued, 11 types of exported medical materials need to be subject to export commodity inspection. The newly added medical materials subject to export commodity inspection will not be subject to origin inspection, and no electronic ledger is required for declaration. The enterprise shall indicate whether it is medical or not at the time of declaration. Among them, for medical materials within the scope of "announcement 5", the attached documents shall be bted according to the above requirements. For other exported medical materials, it is suggested that the enterprise shall, according to the management category of the classification catalogue of medical devices, provide the registration / Filing Certificate of medical device products and the quality and safety statement respectively according to the requirements of "announcement 5" when declaring to the customs.

“5號公告”和“53號公告”所列范圍之外的物資出口，需要提交相關單證嗎？

答：對于公告范圍之外的非醫用防護用品等出口物資，無需提交醫療器械產品注冊/備案證明和質量安全聲明，通關手續按原有要求辦理。

Answer: for non-medical protective articles and other export materials beyond the scope of announcement, it is not necessary to b the registration / Filing Certificate and quality safety statement of medical device products, and the customs bance procedures shall be handled according to the original requirements.

李國杰（經理）：18202125732  

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