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常見問題
CFS自由銷售證書的常見問題解答

1、請問如何辦理出口自由銷售證書/證明?

       答:如果貴公司的產品已通過CE認證及獲得證書,而且有找好歐盟授權代表的。即可委托貴司的歐盟代表辦理此事

2、若是公司產品銷售阿根廷與埃等其他國家,客戶都要求辦理自由銷售證明/證書,我可不可只辦理一張自由銷售證明呢?

       答:不可以。因為一張自由銷售證書/證明它只針對一個國家,在證書上有寫清楚申請銷售的國家。若是有多個國家的客戶要求貴公司要自由銷售證書/證明,貴司就必須針對每個國家申請一張自由銷售證書/證明。

如果量比較多,可以聯絡我們,我們會想辦法幫您節省成本。

3、LOTUS及其母公司能提供哪些服務?

       LOTUS及其母公司做到醫療項目全覆蓋:

       醫療器械認證:ISO13485、 YY/T0287、CE、PPE、FDA-510(K)、QSR820、FDA 21 CFR 210&211 cGMP、CMDCAS、PAL、TGA;

       醫療器械注冊:國內注冊證、生產許可證、經營許可證、進口注冊證、體外診斷試劑注冊證;

       歐盟授權代表:歐代、醫療器械歐洲注冊(MHRA、HPRA)、自由銷售證書(CFS國外、國內)、證書公證(使館公證、商會公證、海牙公證);

       藥品及藥包材:FDA GMP CFR 210 & CFR 2ll/FDA驗廠,歐洲CEP驗廠;美國ANDA申請,歐盟CEP/COS申請,歐盟CEP/COS變更和更新,美國DMF制作與歸檔,歐盟ASMF/EDMF申請,ICH,CTD及eCTD,仿制藥一致性評價,設備驗證咨詢、工藝驗證咨詢、潔凈廠房工程咨詢、生物實驗室設計咨詢、藥品全程注冊咨詢、及各類藥企培訓。

       食品化妝品:保健食品注冊咨詢、保健食品備案咨詢、保健食品技術轉讓咨詢、保健食品GMP咨詢、國際HACCP認證、藥用化妝品注冊、化妝品GMP設計、化妝品質量控制咨詢;

       臨床試驗咨詢;

       體系認證咨詢:ISO9001、ISO14001、ISO18001、TS14969、ISO17025、FSC森林、CAMCAS、ISO 22716、ISO22000、ISO22716、環保產品十環認證、環保產品CCAEPI證書、農業產品GAP認證;

       其他:醫療器械文件翻譯、醫療器械GMP、標準起草、常年認證咨詢顧問、第二方審核、潔凈室設計施工、認證培訓、管理培訓、管理咨詢等等。

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