CFDA和FDA医疗器械软件注册指南对照（上）

John · 发表于 2016-8-6 23:28

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机缘巧合，我开始接触医疗软件注册的工作。我的第一个任务便是协助公司的软件产品，完成FDA的审核要求。作为一个初学医疗器械注册的人，确实是困难重重的，我完全不知该从何着手，因此从熟悉的中文开始，从中国《医疗器械监督管理条例》等法律法规开始着手学习。

下文是我的第一份学习文档，用列表比对的方式罗列了FDA和CFDA对医疗器械软件产品的注册要求。其中得到行业人士的热心校正。在此表示感谢。

另外有一点感悟，便是觉得不能急躁，要有逐步学习的规划路线，例如，首先从阅读和学习整体框架开始，知道软件注册要做什么，然后再逐个部分去学习具体需要描述什么内容，如何描述，FDA官方希望看到的是什么，再次，串联每个部分，便逐渐对此有了自己的了解和感知。

注册所需终归是几份文档，于是有些行业朋友问我，有没有模版？可以说有，也可以说没有。模版是一个文档的框架，前因后果和顺序，标题文字和排版布局，然而其中真正填充的内容才是文档的肉身和灵魂，也是没有参考的，只有真正读懂注册监管机构所需，模版才真正生成于心中。

这是一个专注软件小白的经验分享，希望大家指正和讨论。

参考资料来源：

1、FDA-510(K)

2、General Principles of Software Validation

3、CFDA 医疗器械软件注册技术审查指导原则

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CFDA和FDA医疗器械软件注册指南对照

The CFDA and FDA Medical software registration guide comparison

Only focus on MODERATE CONCERN

仅罗列中等关注级别

EXP1a~1z Means the explain in Appendix 1

EXP2a~2z Means the explain in Appendix 2

	FDA Guide（Appendix 1） FDA 指导方法（附录一）	CFDA Guide（Appendix 2） CFDA 指导方法（附录二）
Level of Concern 关注程度	A statement indicating the Level of Concern and a description of the rationale for that level. 明确器械产品关注程度等级，详述确定该级别的原理。 EXP1a	Security Level: Software security level, determine the reason. 安全性级别：明确软件安全性级别，详述确定该级别的原理。 EXP2b
Software Description 软件描述	A summary overview of the features and software operating environment. 概括产品特征和软件操作环境。 EXP1b	Software Tag: The name, model specifications, release version, manufacturers and production address. 软件标识：明确软件名称、型号规格、发布版本、制造商和生产地址。EXP2a Operating Environment: Hardware configuration, software environment and network conditions. 运行环境：明确软件运行所需的硬件配置、软件环境和网络条件。EXP2e
Device Hazard Analysis 器械危害分析	Tabular description of identified hardware and software hazards, including severity assessment and mitigations. 制表说明硬件和软件危害程度，包括严重度和减缓措施。 EXP1c	Risk Management: Risk management information. 风险管理：提供风险管理资料。EXP2j
Software Requirements Specification (SRS) 软件要求规格书	The complete SRS document. 完整的SRS文档。 EXP1d	Software Requirements Specification (SRS) : The complete SRS document. 需求规范：提供需求规范全文。EXP2k
Architecture Design Chart 架构设计	Detailed depiction of functional units and software modules. May include state diagrams as well as flow charts. 描述功能单元和软件模块的详细设计，可用状态图或流程图。 EXP1e	Structure features: Description the software modules, describes the clinical software function module by user interface diagram. 结构功能：依据体系结构图描述软件组成模块，依据用户界面关系图描述软件临床功能模块。EXP2c Hardware Topology: Describe the physical connection between software and hardware medical devices according the physical topology. 硬件拓扑：依据物理拓扑图描述软件、通用计算机和医疗器械硬件的物理连接关系。EXP2d
Software Design Specification (SDS) 软件详细设计规格说明书	Software design specification document. 软件详细设计说明书 EXP1f	Development Overview: Development language, tools, methods, personnel, time, effort, lines of code. 开发概述：明确开发语言、工具、方法，以及人员、时间、工作量、代码行数。EXP2i Core Algorithm: According to the software design specification (SDS) and specifications, indicate the name, type, uses and clinical functions of the core algorithm. 核心算法：依据软件设计规范（SDS）和说明书列明核心算法的名称、类型、用途和临床功能。EXP2q
Traceability Analysis 可追溯性分析	Traceability among requirements, specifications, identified hazards and mitigations, and Verification and Validation testing. 可追溯性贯穿需求规格说明书、设计规格说明书、风险评估和验证及确认。 EXP1g	×
Software Development Environment Description 软件开发环境的描述（软件生命周期研究）	Summary of software life cycle development plan, including a summary of the configuration management and maintenance activities. 概述软件生命周期开发计划，包括配置管理和维护活动。 EXP1h	Life cycle: Development life cycle plan, configuration management plan and maintenance plan. 生存周期：提供开发生存周期计划、配置管理计划和维护计划的摘要。EXP2l
Verification and Validation Documentation 验证和确认文件	Description of V&V activities at the unit, integration, and system level. System level test protocol, including pass/fail criteria, and tests results. 对单元、集成和系统级别的验证确认活动的描述，包括通过/失败判定标准和测试结果。 EXP1i	Verification and validation: Validation activities in each stage of development, provide the system test, user test plan and report. 验证与确认：概述开发各阶段的验证活动，提供系统测试、用户测试的计划与报告。EXP2m
Revision Level History 版本修订历史	Revision history log,including release version number and date. 版本修订的历史记录、包括发布版本号和发布日期。 EXP1j	Version Update History: Rules of version naming, record full version package, date, type, and specific content of the update, between every register and the previous one. 更新历史：明确版本命名规则，列明本次与前次注册之间历次软件更新的完整版本、日期、类型和具体更新内容。EXP2o
Unresolved Anomalies (Bugs or Defects) 未解决的异常	List of remaining software anomalies, annotated with an explanation of the impact on safety or effectiveness,including operator usage and human factors. 列出未解决的软件异常、注明对安全性、有效性的影响，包括操作者的使用方面和人机交互等方面。 EXP1k	Defect Management: Describe the defect management process, given the total number of defects and the number of residual defects, listed the known remaining defects. 缺陷管理：描述缺陷管理流程，明确已知的缺陷总数和剩余缺陷数，列明已知剩余缺陷情况。EXP2n
Scope of application 适用范围	×	Specific the scope of the software. Imported software description the information from the country of origin. 明确软件的适用范围，进口软件描述原产国情况。EXP2f
Contraindications 禁忌症	×	Specific the contraindications to software or use restrictions. Imported software description the information from the country of origin. 明确软件的禁忌症或使用限制，进口软件描述原产国情况。EXP2g
The History of the Registration 注册历史	×	Specific software registration in China and the country of origin.明确软件在中国和原产国的注册情况。EXP2h
Clinical Assessment 临床评价	×	Provide clinical evaluation information. 提供临床评价资料。EXP2p

附录一：FDA指导方法

SOFTWARE DOCUMENTATION	MINOR CONCERN	MODERATE CONCERN	MAJOR CONCERN
Level of Concern	A statement indicating the Level of Concern and a description of the rationale for that level.
Software Description	A summary overview of the features and software operating environment.
Device Hazard Analysis	Tabular description of identified hardware and software hazards, including severity assessment and mitigations.
Software Requirements Specification (SRS)	Summary of functional requirements from SRS.	The complete SRS document.
Architecture Design Chart	×	Detailed depiction of functional units and software modules. May include state diagrams as well as flow charts.
Software Design Specification (SDS)	×	Software design specification document.
Traceability Analysis	Traceability among requirements, specifications, identified hazards and mitigations, and Verification and Validation testing.
Software Development Environment Description	×	Summary of software life cycle development plan, including a summary of the configuration management and maintenance activities.	Summary of software life cycle development plan. Annotated list of control documents generated during development process. Include the configuration management and maintenance plan documents.
Verification and Validation Documentation	Software functional test plan, pass / fail criteria, and results.	Description of V&V activities at the unit, integration, and system level. System level test protocol, including pass/fail criteria, and tests results.	Description of V&V activities at the unit, integration, and system level. Unit, integration and system level test protocols, including pass/fail criteria, test report,summary, and tests results.
Revision Level History	Revision history log, including release version number and date.
Unresolved Anomalies (Bugs or Defects)	×	List of remaining software anomalies, annotated with an explanation of the impact on safety or effectiveness, including operator usage and human factors.

软件文档	最低关注	中等关注	最高关注
关注级别（LOC）	器械产品LOC总数和选此级别的原因
软件描述	对产品特征和软件操作环境的概括
器械危害分析	制表说明识别硬件和软件危害，包括严重性评估和减少危害的方法
软件规格需求说明书（SRS）	仅概括功能部分的需求	完全的SRS文档
结构设计表	×	功能单元和软件模块的具体描述，一般可用状态表或流程图
软件设计规格说明书（SDS）	×	SDS文档
可追溯性分析	可追溯性贯穿需求、规格说明书、危害识别和减少、验证和确认测试的始终
软件开发环境描述	×	概述软件生命周期开发计划，包括配置管理和维护性活动	概述软件生命周期开发计划，在开发过程中控制文档的注释条目，包括配置管理和维护性活动
验证和确认（V&V）文档	软件功能测试计划，通过/失败标准和测试结果	对单个、整个和系统水平上V&V活动的描述，包括通过/失败标准和测试结果	对单个、整个和系统水平上V&V活动的描述，单个、整体合系统水平测试协议、包括通过/失败标准和测试结果
版本历史	版本历史记录、包括发布版本号和发布日期
未解决的异常（bug或缺陷）	×	列出软件异常情况、包括使用方法和人为因素对安全性和有效性的影响和解释