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常見問題
MHRA注冊的常見問題解答

1.哪些產品需要到MHRA(英國藥品和健康產品管理局)注冊?

       答:MDD:I類和I*類,IVDD:全部類需到歐盟主管注冊。

2.請問是在什么時候必須注冊?

       答:醫療器械制造商,在產品銷往歐盟境內出口前就應該向其歐盟代表所在國的主管當局申請注冊,以免進入海關時出問題和引起法律糾紛,造成不必要的經濟損失。

3.請問注冊周期要多長時間?

       答:一般在45個工作日內可以完成。

4.MHRA注冊要收費嗎?是怎樣收費的呢?

       答:MHRA注冊是需要收取費用的。主管部門注冊收費不是按產品數量收費而是按注冊次數。

       例如:您在一年內注冊兩次,MHRA不會因為您已經注冊過一次就不收取您的第二次注冊費用,他們是注冊一次就會收取一次的費用。

5.哪這個注冊是由誰向主管部門申請的呢?

       答:a.若是貴公司已經找好歐盟授權代表(如Lotus 國際)了,那么貴公司可以委托您的歐盟授權代表來履行您的職責向MHRA提出申請幫貴公司完成并取得注冊證書。

       b. 如果貴公司還沒有找到歐盟授權代表,在歐盟境內又沒有注冊的分公司,您必須指定一個在歐盟境內國內有注冊營業地址的歐盟授權代表公司來履行您的職責。(Lotus 國際就是您最好的選擇!)

6.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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