體外診斷醫療器械

體外診斷醫療器械

       根據體外診斷醫療器械指令 98/79/EC, “體外診斷醫療器械”是制造商旨在單獨或組合在人體外檢查從人體取得的血液及組織供體等標本的一切設備,包括試劑、試劑產品、校準材料、控制材料、成套工具、儀器、裝置、設備或系統等,該器械的應用單純或主要為了獲取以下方面的信息:

       一、  有關生理學或病理學狀態,或

       二、  有關先天性異常,或

       三、  用以確定安全性和可能接收治療者的相容性,或

       四、  用以監測治療措施。

       標本容器也被視為體外診斷醫療器械。標本容器是指為了進行體外診斷檢查而用來容納并保存從人體取得的標本的真空和非真空的器具。

       實驗室使用的一般性產品不屬于體外診斷醫療器械,除非此類產品的某些特點系廠商預定用于體外診斷檢查使用的情況例外。

Lotus國際集團作為您醫療器械的歐盟授權代表,將充當您面對歐盟主管當局的法律實體,代表您,按照醫療器械MDD93/42/EEC指令履行職責,并提供您的產品進入歐盟市場的其它服務。

Lotus國際集團針對體外診斷器械的服務

       一、 迅速在歐盟主管部門完成產品注冊

       二、 指導符合性聲明(Declarations of Conformity)的撰寫

       三、 提供歐盟各國對產品標簽和語言相關的要求

       四、 按照歐盟成員國當地法規和歐盟MEDDEV導則的要求向主管部門提交事故報告

       五、 申請自由銷售證明

       六、 提供產品注冊證明書

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