普通醫療器械

普通醫療器械

什么是醫療器械?

       根據醫療器械MDD 93/42/EEC指令,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,包括制造商旨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。 

       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

       六、 提供產品注冊證明書

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