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)關于醫(yī)療器械臨床試驗備案有關事宜的公告，醫(yī)療器械臨床試驗備案應在試驗項目經倫理審查通過并與臨床試驗機構簽訂協(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，關于醫(yī)療器械臨床試驗備案有關事宜的公告指出，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個工作日內告知原備案管理部門并留有信息變更的記錄。

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