医疗器械临床试验备案需要注意哪些事项

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　　根据医疗器械监督管理条例的规定，开展医疗器械临床试验应当备案，申办者除了需要填写医疗器械临床试验备案表和提交备案表中列出的相关材料外，还需要注意下列事项：

　　一是医疗器械临床试验备案的时机，根据关于医疗器械临床试验备案有关事宜的公告，医疗器械临床试验备案应在试验项目经伦理审查通过并与临床试验机构签订协议或合同后。如果同一个临床试验项目多次备案时，申办者应当同时提供前期已取得的所有备案表。

　　二是医疗器械临床试验备案的期限，在理论上，关于医疗器械临床试验备案有关事宜的公告指出，对于医疗器械临床试验备案表填写完整且提交材料齐全的，接受备案的省级食品药品监督管理部门应当当场备案。不过事实上，虽然很多省份食品药品监督管理部门能够当场完成备案材料的审核，但是由于内部有审批流程而无法当场拿到备案表。

　　三是备案完成后，备案表原件由申办者保存，复印件向临床试验机构提交，如果试验项目起止日期有变化的，应当于变化后10个工作日内告知原备案管理部门并留有信息变更的记录。

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