未獲得藥品監(jiān)督管理部門的注冊(cè)證書，但已獲得國外相關(guān)標(biāo)準(zhǔn)認(rèn)證，能否出口？

答：根據(jù)“5號(hào)公告”規(guī)定，出口相關(guān)醫(yī)療物資應(yīng)取得我國醫(yī)療器械產(chǎn)品注冊(cè)證書，符合進(jìn)口國(地區(qū))質(zhì)量標(biāo)準(zhǔn)要求。針對(duì)已獲得國外相關(guān)標(biāo)準(zhǔn)認(rèn)證，但尚未取得我國醫(yī)療器械產(chǎn)品注冊(cè)證書的情況，建議相關(guān)企業(yè)按規(guī)定向藥品監(jiān)督管理部門提出申請(qǐng)，及時(shí)獲取注冊(cè)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(duì)出口醫(yī)療物資的管理還會(huì)有變化嗎？

答：根據(jù)“5號(hào)公告”所述，為了保障相關(guān)出口醫(yī)療物資的質(zhì)量安全，商務(wù)部、海關(guān)總署、國家藥品監(jiān)督管理局將視疫情發(fā)展情況動(dòng)態(tài)調(diào)整出口質(zhì)量監(jiān)管措施。請(qǐng)廣大出口企業(yè)提前做好準(zhǔn)備，確保產(chǎn)品質(zhì)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(jīng)理）:18202125732  

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