醫療器械臨床試驗備案需要注意哪些事項

test4

　　根據醫療器械監督管理條例的規定，開(kāi)展醫療器械臨床試驗應當備案，申辦者除了需要填寫(xiě)醫療器械臨床試驗備案表和提交備案表中列出的相關(guān)材料外，還需要注意下列事項：

　　一是醫療器械臨床試驗備案的時(shí)機，根據關(guān)于醫療器械臨床試驗備案有關(guān)事宜的公告，醫療器械臨床試驗備案應在試驗項目經(jīng)倫理審查通過(guò)并與臨床試驗機構簽訂協(xié)議或合同后。如果同一個(gè)臨床試驗項目多次備案時(shí)，申辦者應當同時(shí)提供前期已取得的所有備案表。

　　二是醫療器械臨床試驗備案的期限，在理論上，關(guān)于醫療器械臨床試驗備案有關(guān)事宜的公告指出，對于醫療器械臨床試驗備案表填寫(xiě)完整且提交材料齊全的，接受備案的省級食品藥品監督管理部門(mén)應當當場(chǎng)備案。不過(guò)事實(shí)上，雖然很多省份食品藥品監督管理部門(mén)能夠當場(chǎng)完成備案材料的審核，但是由于內部有審批流程而無(wú)法當場(chǎng)拿到備案表。

　　三是備案完成后，備案表原件由申辦者保存，復印件向臨床試驗機構提交，如果試驗項目起止日期有變化的，應當于變化后10個(gè)工作日內告知原備案管理部門(mén)并留有信息變更的記錄。

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