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有源植入醫療器械

有源植入醫療器械

什么是有源植入式醫療器械?

       根據有源植入式醫療器械指令(90/385/EEC),醫療器械是指單獨或者組合使用于人體的儀器、設備、器具、軟件、材料或者其 他物品,包括制造商專門生產的以診斷為目的,旨在讓器械正常使用所必須的配套軟件;該器械的使用旨在達到下列預期目的:

       一、  對疾病的診斷、預防、監護、治療或緩解;

       二、 對損傷或者殘疾的診斷、監護、治療、緩解或補償

       三、 對解剖或生理過程的研究、替換和變更

       四、 妊娠控制

       該器械用于人體體表及體內的作用不是通過藥理學、免疫學或者代謝的手段獲得,但是可能有這些手段參與并起一定的輔助作用。

       “有源醫療器械”是指依靠電能源或任何非人體或重力直接產生的動力源而工作的醫療器械。

       “有源植入式醫療器械”是指通過外科手術或醫療方式全部或部分引入人體或通過醫療干預引入某個自然孔口,并在完成上述程序后保留在人體內的任何有源醫療器械。

       1. 確保產品符合相關要求

       2. 產品按歐盟標準完成安全分類

       3. 必須有公告機構參與(I類產品除外),并有包含符合性聲明(Delaration of Conformity)在內的技術文檔 

       4. 已經有CE標志,且完成了標簽設計

       5. 歐盟授權代表也必須涵括在在制造商產品責任險中

       Lotus國際集團作為您有源植入式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,按照有源植入式醫療器械指令履行職責,并提供您的產品進入歐盟市場的其它服務。

Lotus國際集團針對植入式醫療器械的服務

       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

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