醫(yī)療器械臨床試驗備案需要注意哪些事項

test4

　　根據(jù)醫(yī)療器械監(jiān)督管理條例的規(guī)定，開展醫(yī)療器械臨床試驗應當備案，申辦者除了需要填寫醫(yī)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(yī)療器械臨床試驗備案的時機，根據(jù)關(guān)于醫(yī)療器械臨床試驗備案有關(guān)事宜的公告，醫(yī)療器械臨床試驗備案應在試驗項目經(jīng)倫理審查通過并與臨床試驗機構(gòu)簽訂協(xié)議或合同后。如果同一個臨床試驗項目多次備案時，申辦者應當同時提供前期已取得的所有備案表。

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

　　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(gòu)提交，如果試驗項目起止日期有變化的，應當于變化后10個工作日內(nèi)告知原備案管理部門并留有信息變更的記錄。

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