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歐洲MHRA注冊

MHRA注冊

       根據歐盟規定和客戶要求, 所有體外診斷器械(包括試劑)(IVD)和一類醫療器械(Class I MD)在加貼CE標志(CE Marking)之前必須通過歐盟授權代表向其所在國的歐盟主管機構CA進行注冊并取得注冊證書和注冊號碼。

       制造商選擇的歐盟授權代表如在英國,就須要到英國MHRA (Medicines and Healthcare products Regulatory Agency英國藥品和健康產品管理局)辦理注冊并取得注冊證明。

       無論是歐盟的醫療器械指令(MDD 93/42/eec) 和體外診斷醫療器械指令(IVD 98/79/ec)都要求醫療器械制造商或其歐盟授權代表,向其注冊的營業地點所在的歐洲經濟區EEA成員國的主管機關(CA-Competent Authority),注冊并提供某些資料和信息。這些要求已轉變為所有歐洲經濟區EEA成員國的本國法律。 

       所在EEA成員國的主管機關CA在收到醫療器械制造商或其歐盟授權代表的注冊申請,并進行適當數據處理后,應當告知歐盟委員會。在要求的情況下,所在EEA成員國的主管機關CA應當告知其他EEA成員國的主管機關 (CAs-Competent Authorities)。

       備注: EEA成員國內的制造商可以自己直接向主管當局進行注冊和通告。非EEA的(比如中國的)制造商在加貼CE標志時,就應該委托其歐盟代表到歐盟代表所在國的主管當局將制造商及產品信息完成注冊(Registration)并取得注冊號。 

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