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醫療器械臨床服務流程
CREATE TIME:2018-06-29 11:32BROWSE TIMES:2292
根據《醫療器械監督管理條例》(國務院令第650號)的規定,第Ⅰ類醫療器械實行產品備案管理,不需要進行臨床試驗,但需要提交臨床評價資料;第Ⅱ、Ⅲ類醫療器械注冊時,應當進行臨床試驗(免于進行臨床試驗的第Ⅱ類醫療器械目錄;免于進行臨床試驗的第Ⅲ類醫療器械目錄的醫療器械除外);免于進行臨床試驗的醫療器械,在進行注冊申報時,仍需提供臨床評價資料。
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