feat(regulatory): 对齐附件4目录核查规则

review_agent/regulatory_review/rules/nmpa_ivd_registration_v1.yaml

@@ -1,58 +1,503 @@
 code: nmpa_ivd_registration_v1
-name: NMPA IVD 注册资料 Demo 规则
+name: NMPA IVD 注册资料附件 4 对齐规则
 rag_collection: nmpa_ivd_registration_v1
-source_material_dir: docs/0.原始材料/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
+source_material_dir: docs/0.原始材料
+attachment4_required_codes:
+  - "1"
+  - "1.1"
+  - "1.2"
+  - "1.3"
+  - "1.4"
+  - "1.5"
+  - "1.6"
+  - "1.7"
+  - "2"
+  - "2.1"
+  - "2.2"
+  - "2.3"
+  - "2.4"
+  - "2.5"
+  - "2.6"
+  - "3"
+  - "3.1"
+  - "3.2"
+  - "3.3"
+  - "3.4"
+  - "3.5"
+  - "3.6"
+  - "3.7"
+  - "3.8"
+  - "4"
+  - "4.1"
+  - "4.2"
+  - "5"
+  - "5.1"
+  - "5.2"
+  - "5.3"
+  - "5.4"
+  - "6"
+  - "6.1"
+  - "6.2"
+  - "6.3"
+  - "6.4"
+  - "6.5"
+  - "6.6"
+  - "6.7"
+  - "6.8"
+  - "6.9"
+  - "6.10"
 requirements:
-  - code: product_technical_requirements
-    title: 产品技术要求
+  - code: attachment4_1_regulatory_info
+    rule_id: A4-1
+    attachment4_code: "1"
+    title: 监管信息
+    type: chapter
+    severity: high
+    category: completeness
+    file_keywords: [监管信息]
+    aliases: [监管资料]
+    suggestion: 请补充监管信息章节及其目录项。
+    citation_query: 附件4 监管信息 体外诊断试剂 注册申报资料
+    structure_required: true
+  - code: attachment4_1_1_toc
+    rule_id: A4-1.1
+    attachment4_code: "1.1"
+    title: 章节目录
+    type: directory
+    severity: medium
+    category: completeness
+    file_keywords: [章节目录, 目录]
+    aliases: [监管信息目录]
+    suggestion: 请补充监管信息章节目录。
+    citation_query: 附件4 监管信息 章节目录
+  - code: attachment4_1_2_application_form
+    rule_id: A4-1.2
+    attachment4_code: "1.2"
+    title: 申请表
     type: required
     severity: blocking
     category: completeness
-    file_keywords:
-      - 产品技术要求
-    suggestion: 请补充产品技术要求并确认版本与注册申请资料一致。
-    citation_query: 体外诊断试剂 产品技术要求 注册申报资料
-  - code: instructions_for_use
-    title: 说明书
+    file_keywords: [申请表, 注册申请表]
+    aliases: [医疗器械注册申请表]
+    suggestion: 请补充注册申请表并核对注册类型、管理类别和分类编码。
+    citation_query: 附件4 监管信息 申请表
+  - code: attachment4_1_3_terms
+    rule_id: A4-1.3
+    attachment4_code: "1.3"
+    title: 术语/缩写词列表
+    type: recommended
+    severity: medium
+    category: completeness
+    file_keywords: [术语, 缩写词, 缩略语]
+    suggestion: 请补充术语和缩写词列表。
+    citation_query: 附件4 术语 缩写词列表
+  - code: attachment4_1_4_product_list
+    rule_id: A4-1.4
+    attachment4_code: "1.4"
+    title: 产品列表
     type: required
     severity: high
     category: completeness
-    file_keywords:
-      - 说明书
-      - 使用说明
-    required_sections:
-      - 储存条件
-      - 有效期
-      - 样本要求
-    suggestion: 请补充说明书并核对储存条件、有效期和样本要求章节。
-    citation_query: 体外诊断试剂 说明书 储存条件 有效期 样本要求
+    file_keywords: [产品列表, 产品清单]
+    suggestion: 请补充申报产品列表。
+    citation_query: 附件4 产品列表
+  - code: attachment4_1_5_related_files
+    rule_id: A4-1.5
+    attachment4_code: "1.5"
+    title: 关联文件
+    type: conditional
+    severity: medium
+    category: completeness
+    file_keywords: [关联文件, 关联注册, 引用文件]
+    suggestion: 如存在关联注册或引用资料，请补充关联文件说明。
+    citation_query: 附件4 关联文件
+  - code: attachment4_1_6_pre_submission
+    rule_id: A4-1.6
+    attachment4_code: "1.6"
+    title: 申报前与监管机构的联系情况和沟通记录
+    type: conditional
+    severity: medium
+    category: completeness
+    file_keywords: [沟通记录, 监管机构, 申报前]
+    suggestion: 如有申报前沟通，请补充沟通记录；如无，请说明不适用。
+    citation_query: 附件4 申报前 监管机构 沟通记录
+  - code: attachment4_1_7_declaration
+    rule_id: A4-1.7
+    attachment4_code: "1.7"
+    title: 符合性声明
+    type: required
+    severity: blocking
+    category: completeness
+    file_keywords: [符合性声明, 声明]
+    suggestion: 请补充符合性声明。
+    citation_query: 附件4 符合性声明
+  - code: attachment4_2_summary
+    rule_id: A4-2
+    attachment4_code: "2"
+    title: 综述资料
+    type: chapter
+    severity: high
+    category: completeness
+    file_keywords: [综述资料]
+    suggestion: 请补充综述资料章节。
+    citation_query: 附件4 综述资料
+    structure_required: true
+  - code: attachment4_2_1_toc
+    rule_id: A4-2.1
+    attachment4_code: "2.1"
+    title: 章节目录
+    type: directory
+    severity: medium
+    category: completeness
+    file_keywords: [章节目录, 综述资料目录]
+    suggestion: 请补充综述资料章节目录。
+    citation_query: 附件4 综述资料 章节目录
+  - code: attachment4_2_2_overview
+    rule_id: A4-2.2
+    attachment4_code: "2.2"
+    title: 概述
+    type: required
+    severity: high
+    category: completeness
+    file_keywords: [概述]
+    suggestion: 请补充产品概述。
+    citation_query: 附件4 概述
+  - code: attachment4_2_3_product_description
+    rule_id: A4-2.3
+    attachment4_code: "2.3"
+    title: 产品描述
+    type: required
+    severity: high
+    category: completeness
+    file_keywords: [产品描述]
+    suggestion: 请补充产品描述。
+    citation_query: 附件4 产品描述
+  - code: attachment4_2_4_intended_use
+    rule_id: A4-2.4
+    attachment4_code: "2.4"
+    title: 预期用途
+    type: required
+    severity: high
+    category: completeness
+    file_keywords: [预期用途]
+    suggestion: 请补充预期用途资料。
+    citation_query: 附件4 预期用途
+  - code: attachment4_2_5_marketing_history
+    rule_id: A4-2.5
+    attachment4_code: "2.5"
+    title: 申报产品上市历史
+    type: conditional
+    severity: medium
+    category: completeness
+    file_keywords: [上市历史]
+    suggestion: 如产品已有上市历史，请补充相关说明；如无，请说明不适用。
+    citation_query: 附件4 上市历史
+  - code: attachment4_2_6_other_summary
+    rule_id: A4-2.6
+    attachment4_code: "2.6"
+    title: 其他需说明的内容
+    type: conditional
+    severity: medium
+    category: completeness
+    file_keywords: [其他需说明, 其他说明]
+    suggestion: 请补充其他需说明内容或不适用说明。
+    citation_query: 附件4 其他需说明
+  - code: attachment4_3_nonclinical
+    rule_id: A4-3
+    attachment4_code: "3"
+    title: 非临床资料
+    type: chapter
+    severity: high
+    category: completeness
+    file_keywords: [非临床资料]
+    suggestion: 请补充非临床资料章节。
+    citation_query: 附件4 非临床资料
+    structure_required: true
+  - code: attachment4_3_1_toc
+    rule_id: A4-3.1
+    attachment4_code: "3.1"
+    title: 章节目录
+    type: directory
+    severity: medium
+    category: completeness
+    file_keywords: [章节目录, 非临床资料目录]
+    suggestion: 请补充非临床资料章节目录。
+    citation_query: 附件4 非临床资料 章节目录
+  - code: attachment4_3_2_risk_management
+    rule_id: A4-3.2
+    attachment4_code: "3.2"
+    title: 产品风险管理资料
+    type: required
+    severity: high
+    category: completeness
+    file_keywords: [产品风险管理, 风险管理资料]
+    suggestion: 请补充产品风险管理资料。
+    citation_query: 附件4 产品风险管理资料
+  - code: essential_principles_checklist
+    rule_id: A4-3.3
+    attachment4_code: "3.3"
+    title: 体外诊断试剂安全和性能基本原则清单
+    type: recommended
+    severity: medium
+    category: completeness
+    file_keywords: [安全和性能基本原则, 基本原则清单]
+    aliases: [安全和性能基本原则清单]
+    suggestion: 建议补充安全和性能基本原则清单，便于审评追溯。
+    citation_query: 附件4 安全和性能基本原则清单
+  - code: product_technical_requirements
+    rule_id: A4-3.4
+    attachment4_code: "3.4"
+    title: 产品技术要求及检验报告
+    type: required
+    severity: blocking
+    category: completeness
+    file_keywords: [产品技术要求, 注册检验报告, 检验报告]
+    aliases: [产品技术要求, 注册检验报告]
+    required_sections: [产品技术要求, 检验报告]
+    suggestion: 请补充产品技术要求及注册检验报告，并确认二者覆盖型号一致。
+    citation_query: 附件4 产品技术要求 检验报告
   - code: registration_test_report
+    rule_id: A4-3.4-R
+    attachment4_code: "3.4"
     title: 注册检验报告
     type: required
     severity: blocking
     category: completeness
-    file_keywords:
-      - 注册检验报告
-      - 检验报告
+    file_keywords: [注册检验报告, 检验报告]
     suggestion: 请补充注册检验报告并复核报告覆盖的产品型号。
-    citation_query: 体外诊断试剂 注册检验报告 注册申报资料
+    citation_query: 附件4 注册检验报告
+  - code: attachment4_3_5_analytical_performance
+    rule_id: A4-3.5
+    attachment4_code: "3.5"
+    title: 分析性能研究
+    type: required
+    severity: high
+    category: completeness
+    file_keywords: [分析性能研究, 分析性能]
+    suggestion: 请补充分析性能研究资料。
+    citation_query: 附件4 分析性能研究
+  - code: attachment4_3_6_stability
+    rule_id: A4-3.6
+    attachment4_code: "3.6"
+    title: 稳定性研究
+    type: required
+    severity: high
+    category: completeness
+    file_keywords: [稳定性研究, 稳定性]
+    suggestion: 请补充稳定性研究资料。
+    citation_query: 附件4 稳定性研究
+  - code: attachment4_3_7_reference_interval
+    rule_id: A4-3.7
+    attachment4_code: "3.7"
+    title: 阳性判断值或参考区间研究
+    type: required
+    severity: high
+    category: completeness
+    file_keywords: [阳性判断值, 参考区间]
+    suggestion: 请补充阳性判断值或参考区间研究资料。
+    citation_query: 附件4 阳性判断值 参考区间
+  - code: attachment4_3_8_other_nonclinical
+    rule_id: A4-3.8
+    attachment4_code: "3.8"
+    title: 其他资料
+    type: conditional
+    severity: medium
+    category: completeness
+    file_keywords: [其他资料]
+    suggestion: 请补充非临床其他资料或不适用说明。
+    citation_query: 附件4 非临床 其他资料
+  - code: attachment4_4_clinical_evaluation
+    rule_id: A4-4
+    attachment4_code: "4"
+    title: 临床评价资料
+    type: chapter
+    severity: high
+    category: completeness
+    file_keywords: [临床评价资料, 临床资料]
+    suggestion: 请补充临床评价资料章节。
+    citation_query: 附件4 临床评价资料
+    structure_required: true
+  - code: attachment4_4_1_toc
+    rule_id: A4-4.1
+    attachment4_code: "4.1"
+    title: 章节目录
+    type: directory
+    severity: medium
+    category: completeness
+    file_keywords: [章节目录, 临床评价资料目录]
+    suggestion: 请补充临床评价资料章节目录。
+    citation_query: 附件4 临床评价资料 章节目录
   - code: clinical_evaluation
+    rule_id: A4-4.2
+    attachment4_code: "4.2"
     title: 临床评价资料
     type: conditional
     severity: high
     category: completeness
-    file_keywords:
-      - 临床评价
-      - 临床试验
+    file_keywords: [临床评价, 临床试验, 免临床, 同品种比对]
     suggestion: 请根据适用情形补充临床评价资料或说明豁免依据。
-    citation_query: 体外诊断试剂 临床评价资料 注册申报
-  - code: essential_principles_checklist
-    title: 安全和性能基本原则清单
-    type: recommended
+    citation_query: 附件4 临床评价资料 注册申报
+  - code: attachment4_5_ifu_label
+    rule_id: A4-5
+    attachment4_code: "5"
+    title: 产品说明书和标签样稿
+    type: chapter
+    severity: high
+    category: completeness
+    file_keywords: [产品说明书和标签样稿, 说明书, 标签样稿]
+    suggestion: 请补充产品说明书和标签样稿章节。
+    citation_query: 附件4 产品说明书 标签样稿
+    structure_required: true
+  - code: attachment4_5_1_toc
+    rule_id: A4-5.1
+    attachment4_code: "5.1"
+    title: 章节目录
+    type: directory
     severity: medium
     category: completeness
-    file_keywords:
-      - 安全和性能基本原则
-      - 基本原则清单
-    suggestion: 建议补充安全和性能基本原则清单，便于审评追溯。
-    citation_query: 体外诊断试剂 安全和性能基本原则清单
+    file_keywords: [章节目录, 说明书目录, 标签目录]
+    suggestion: 请补充产品说明书和标签样稿章节目录。
+    citation_query: 附件4 说明书 标签 章节目录
+  - code: instructions_for_use
+    rule_id: A4-5.2
+    attachment4_code: "5.2"
+    title: 产品说明书
+    type: required
+    severity: high
+    category: completeness
+    file_keywords: [说明书, 产品说明书, 使用说明]
+    aliases: [说明书]
+    required_sections: [储存条件, 有效期, 样本要求]
+    suggestion: 请补充说明书并核对储存条件、有效期和样本要求章节。
+    citation_query: 附件4 产品说明书 储存条件 有效期 样本要求
+  - code: attachment4_5_3_label
+    rule_id: A4-5.3
+    attachment4_code: "5.3"
+    title: 标签样稿
+    type: required
+    severity: high
+    category: completeness
+    file_keywords: [标签样稿, 标签]
+    suggestion: 请补充标签样稿。
+    citation_query: 附件4 标签样稿
+  - code: attachment4_5_4_other_ifu
+    rule_id: A4-5.4
+    attachment4_code: "5.4"
+    title: 其他资料
+    type: conditional
+    severity: medium
+    category: completeness
+    file_keywords: [其他资料]
+    suggestion: 请补充说明书和标签相关其他资料或不适用说明。
+    citation_query: 附件4 说明书 标签 其他资料
+  - code: attachment4_6_quality_system
+    rule_id: A4-6
+    attachment4_code: "6"
+    title: 质量管理体系文件
+    type: chapter
+    severity: high
+    category: completeness
+    file_keywords: [质量管理体系文件, 质量体系, 质量管理体系]
+    suggestion: 请补充质量管理体系文件章节。
+    citation_query: 附件4 质量管理体系文件
+    structure_required: true
+  - code: attachment4_6_1_overview
+    rule_id: A4-6.1
+    attachment4_code: "6.1"
+    title: 综述
+    type: required
+    severity: high
+    category: completeness
+    file_keywords: [综述]
+    suggestion: 请补充质量管理体系综述。
+    citation_query: 附件4 质量管理体系 综述
+  - code: attachment4_6_2_toc
+    rule_id: A4-6.2
+    attachment4_code: "6.2"
+    title: 章节目录
+    type: directory
+    severity: medium
+    category: completeness
+    file_keywords: [章节目录, 质量管理体系目录]
+    suggestion: 请补充质量管理体系文件章节目录。
+    citation_query: 附件4 质量管理体系 章节目录
+  - code: attachment4_6_3_manufacturing
+    rule_id: A4-6.3
+    attachment4_code: "6.3"
+    title: 生产制造信息
+    type: required
+    severity: high
+    category: completeness
+    file_keywords: [生产制造信息, 生产制造]
+    suggestion: 请补充生产制造信息。
+    citation_query: 附件4 生产制造信息
+  - code: attachment4_6_4_qms_procedure
+    rule_id: A4-6.4
+    attachment4_code: "6.4"
+    title: 质量管理体系程序
+    type: required
+    severity: high
+    category: completeness
+    file_keywords: [质量管理体系程序, 质量体系程序]
+    suggestion: 请补充质量管理体系程序。
+    citation_query: 附件4 质量管理体系程序
+  - code: attachment4_6_5_management
+    rule_id: A4-6.5
+    attachment4_code: "6.5"
+    title: 管理职责程序
+    type: required
+    severity: high
+    category: completeness
+    file_keywords: [管理职责程序, 管理职责]
+    suggestion: 请补充管理职责程序。
+    citation_query: 附件4 管理职责程序
+  - code: attachment4_6_6_resource
+    rule_id: A4-6.6
+    attachment4_code: "6.6"
+    title: 资源管理程序
+    type: required
+    severity: high
+    category: completeness
+    file_keywords: [资源管理程序, 资源管理]
+    suggestion: 请补充资源管理程序。
+    citation_query: 附件4 资源管理程序
+  - code: attachment4_6_7_realization
+    rule_id: A4-6.7
+    attachment4_code: "6.7"
+    title: 产品实现程序
+    type: required
+    severity: high
+    category: completeness
+    file_keywords: [产品实现程序, 产品实现]
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