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  • IVD clinical trial workflow chart IVD臨床試驗工作流程圖,簡要說明了臨床試驗的各個階段,各階段主要工作流程及要求。 Time:2018-7-9 16:15:38 View:2239
  • 醫(yī)療器械臨床服務(wù)流程 根據(jù)《醫(yī)療器械監(jiān)督管理條例》(國務(wù)院令第650號)的規(guī)定,第Ⅰ類醫(yī)療器械實行產(chǎn)品備案管理,不需要進(jìn)行臨床試驗,但需要提交臨床評價資料;第Ⅱ、Ⅲ類醫(yī)療器械注冊時,應(yīng)當(dāng)進(jìn)行臨床試驗(免于進(jìn)行臨床試驗的第Ⅱ類醫(yī)療器械目錄;免于進(jìn)行臨床試驗的第Ⅲ類醫(yī)療器械目錄的醫(yī)療器械除外);免于進(jìn)行臨床試驗的醫(yī)療器械,在進(jìn)行注冊申報時,仍需提供臨床評價資料。 Time:2018-6-29 11:32:16 View:1987

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