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源興醫(yī)療

標(biāo)題: 醫(yī)療器械臨床試驗(yàn)備案需要注意哪些事項(xiàng) [打印本頁(yè)]

作者: test4 時(shí)間: 2018-8-1 10:05
標(biāo)題: 醫(yī)療器械臨床試驗(yàn)備案需要注意哪些事項(xiàng)
　　根據(jù)醫(yī)療器械監(jiān)督管理?xiàng)l例的規(guī)定，開(kāi)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(xiě)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(guò)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(duì)于醫(yī)療器械臨床試驗(yàn)備案表填寫(xiě)完整且提交材料齊全的，接受備案的省級(jí)食品藥品監(jiān)督管理部門(mén)應(yīng)當(dāng)當(dāng)場(chǎng)備案。不過(guò)事實(shí)上，雖然很多省份食品藥品監(jiān)督管理部門(mén)能夠當(dāng)場(chǎng)完成備案材料的審核，但是由于內(nèi)部有審批流程而無(wú)法當(dāng)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(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(mén)并留有信息變更的記錄。

作者: 風(fēng)流七仔rlqx 時(shí)間: 2018-8-6 21:19
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作者: 王者閃電手x 時(shí)間: 2018-8-8 20:33
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作者: 小想人158 時(shí)間: 2018-8-9 14:58
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作者: 余君海430 時(shí)間: 2018-8-10 08:41
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作者: uulb55 時(shí)間: 2018-10-12 10:08

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作者: ohnfb 時(shí)間: 2019-1-29 08:34
樓主，太愛(ài)你了。

作者: 極業(yè)天蚩p 時(shí)間: 2019-4-5 00:25
也是支持，我代表大家頂你了

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作者: kxuzg 時(shí)間: 2019-5-13 20:46
您好：;點(diǎn)數(shù)優(yōu)惠：正規(guī)稅票：聯(lián)系：15040371013

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