醫(yī)療器械臨床試驗(yàn)備案需要注意哪些事項(xiàng)

test4

　　根據(jù)醫(yī)療器械監(jiān)督管理?xiàng)l例的規(guī)定，開展醫(yī)療器械臨床試驗(yàn)應(yīng)當(dāng)備案，申辦者除了需要填寫醫(yī)療器械臨床試驗(yàn)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(xiàng)：

　　一是醫(yī)療器械臨床試驗(yàn)備案的時(shí)機(jī)，根據(jù)關(guān)于醫(yī)療器械臨床試驗(yàn)備案有關(guān)事宜的公告，醫(yī)療器械臨床試驗(yàn)備案應(yīng)在試驗(yàn)項(xiàng)目經(jīng)倫理審查通過并與臨床試驗(yàn)機(jī)構(gòu)簽訂協(xié)議或合同后。如果同一個(gè)臨床試驗(yàn)項(xiàng)目多次備案時(shí)，申辦者應(yīng)當(dāng)同時(shí)提供前期已取得的所有備案表。

　　二是醫(yī)療器械臨床試驗(yàn)備案的期限，在理論上，關(guān)于醫(yī)療器械臨床試驗(yàn)備案有關(guān)事宜的公告指出，對于醫(yī)療器械臨床試驗(yàn)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(yīng)當(dāng)當(dāng)場備案。不過事實(shí)上，雖然很多省份食品藥品監(jiān)督管理部門能夠當(dāng)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(dāng)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(fù)印件向臨床試驗(yàn)機(jī)構(gòu)提交，如果試驗(yàn)項(xiàng)目起止日期有變化的，應(yīng)當(dāng)于變化后10個(gè)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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