国家药监局关于发布《医疗器械产品注册项目立卷审查要求》等文件的通告（2022年第40号）NMPA20220831
发布时间：2022-08-31
为进一步深化审评审批制度改革，鼓励医疗器械创新，按照《医疗器械注册与备案管理办法》（国家市场监督管理总局令第47号）、《体外诊断试剂注册与备案管理办法》（国家市场监督管理总局令第48号）、《国家药品监督管理局关于公布医疗器械注册申报资料要求和批准证明文件格式的公告》（2021年第121号）、《国家药品监督管理局关于公布体外诊断试剂注册申报资料要求和批准证明文件格式的公告》（2021年第122号）和《国家药品监督管理局关于实施〈医疗器械注册与备案管理办法〉〈体外诊断试剂注册与备案管理办法〉有关事项的通告》（2021年第76号）等有关要求，国家药品监督管理局组织对现行的《医疗器械产品注册项目立卷审查要求（试行）》等文件进行了全面修订。
国家药品监督管理局医疗器械技术审评中心在受理环节按照修订后的立卷审查要求对相应申请的申报资料进行审查，对申报资料进入技术审评环节的完整性、合规性、一致性进行判断。立卷审查不对产品安全性、有效性评价的合理性、充分性进行分析，不对产品风险受益比进行判定。立卷审查适用于医疗器械注册、许可事项变更、临床试验审批等申请事项。
现将修订后的文件予以发布，自发布之日起实施，《国家药监局关于发布〈医疗器械产品注册项目立卷审查要求（试行）〉等文件的通告》（2019年第42号）同时废止。
特此通告。
附件：1.医疗器械产品注册项目立卷审查要求
2.医疗器械变更注册项目立卷审查要求
3.医疗器械免临床评价目录对比立卷审查表
4.医疗器械临床评价立卷审查表
5.体外诊断试剂产品注册项目立卷审查要求
6.体外诊断试剂变更注册项目立卷审查要求
7.体外诊断试剂临床评价立卷审查表（非临床试验）
8.体外诊断试剂临床评价立卷审查表（临床试验）
9.医疗器械临床试验审批项目立卷审查要求
10.医疗器械延续注册项目立卷审查要求
11.体外诊断试剂延续注册项目立卷审查要求
国家药监局
2022年8月26日
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