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技术文件的要求?

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Anonymous userUser from: 广东省
2022-02-09 21:39

MDR中添加了对技术文件内容的要求;且明确指出上市后监管计划和安全性更新报告(PSUR)都是技术文件的一部分,并要求依据上市后监管体系收集的资料对技术文件中相应信息进行更新。


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