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醫療器械注冊變更 根據《醫療器械監督管理條例》(國務院令第650號)的規定,已注冊的第二類、第三類醫療器械,醫療器械注冊證及其附件載明的內容發生變化,申請人應當向原注冊部門申請注冊變更,并按照相關要求提交申報資料。 Time:2018-7-4 15:49:27 View:3562
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醫療器械首次注冊流程 根據《醫療器械監督管理條例》(國務院令第650號)的規定,對醫療器械按照風險程度實行分類管理。 第Ⅰ類是風險程度低,境內生產企業需要在所在地市藥監局進行備案,境外醫療器械生產企業需要委托境內代理人在CFDA進行備案。第Ⅱ類是具有中度風險,境內生產企業需要在所在地省(直轄市)藥監局進行注冊,境外醫療器械生產企業需要委托境內代理人在CFDA進行注冊。第Ⅲ類是具有較高風險,均需要在CFDA進行注冊。 Time:2018-6-29 11:31:24 View:3682