未獲得藥品監督管理部門的注冊證書，但已獲得國外相關標準認證，能否出口？

答：根據“5號公告”規定，出口相關醫療物資應取得我國醫療器械產品注冊證書，符合進口國(地區)質量標準要求。針對已獲得國外相關標準認證，但尚未取得我國醫療器械產品注冊證書的情況，建議相關企業按規定向藥品監督管理部門提出申請，及時獲取注冊證書。

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 conbs to the quality standard requirements of the importing country (region). In view of the situation that the company has obtained the certification of relevant foreign standards 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.

國家對出口醫療物資的管理還會有變化嗎？

答：根據“5號公告”所述，為了保障相關出口醫療物資的質量安全，商務部、海關總署、國家藥品監督管理局將視疫情發展情況動態調整出口質量監管措施。請廣大出口企業提前做好準備，確保產品質量安全。

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.

李國杰（經理）:18202125732  

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