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中國出口證明

中國的出口證明

       一、中國醫療器械產品出口銷售證明書依據產品是否已取得醫療器械注冊證分為兩種格式。       

       對于已取得醫療器械注冊證的產品,其出口銷售證明書的主要內容為:產品符合中華人民共和國有關標準,已在中國注冊,準許在中國市場銷售,出口不受限制。

       對于未取得醫療器械產品注冊證的產品,其出口銷售證明書的主要內容為:產品未在中國注冊,尚未進入中國市場,但出口不受限制。      

       二、醫療器械出口銷售證明書的有效期為2年。

       三、醫療器械產品出口銷售證明書的申請者可以是生產企業或出口企業。

       四、已取得醫療器械注冊證的產品,申請醫療器械產品出口銷售證明書,應填寫申請表,并提交相關文件。

              (一)所出口產品生產者的《醫療器械生產企業許可證》(復印件)
              (二)所出口產品的《醫療器械注冊證》(復印件)
              (三)出口企業的營業執照(復印件)
              (四)申請者的自我保證聲明,保證所出口產品滿足藥品監督管理部門對該產品生產和注冊的法規要求,所提交的材料真實合法。

              所提交的證書復印件需加蓋證書所屬企業公章。       

       五、未取得醫療器械產品注冊證的產品,不能申請醫療產品出口銷售證明書!

       六、醫療出口企業應保證所出口產品符合出口要求,在出口過程中所發生的一切法律責任,由出口企業自行承擔。

       七、醫療器械產品出口銷售證明書的工作時限為15個工作日。

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