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醫療器械CE認證流程 “CE”標志是一種產品安全認證標志,被視為制造商打開并進入歐洲市場的通行證。在歐盟市場“CE”標志屬強制性認證標志,不論是歐盟內部企業生產的醫療器械,還是其他國家生產的醫療器械,如果要在歐盟市場上自由流通,就必須加貼“CE”標志,以表明醫療器械分別符合歐盟《有源植入醫療器械指令》、《醫療器械指令》、《體外診斷器械指令》的基本要求。 Time:2018-6-29 11:34:07 View:1792