医疗器械独立软件现场核查问题分析及若干建议  

Analysis of Field Inspection Issues and Some Suggestions for Software as Medical Device

作　　者：杨义强 范之劲 郭术廷 YANG Yiqiang;FAN Zhijin;GUO Shuting(Shanghai Medical Device and Cosmetics Evaluation and Verification Center,Shanghai,200020;Shanghai Municipal Drug Administration,Shanghai,200233)

机构地区：[1]上海市医疗器械化妆品审评核查中心,上海市200020 [2]上海市药品监督管理局,上海市200233

出　　处：《中国医疗器械杂志》2024年第3期346-351,共6页Chinese Journal of Medical Instrumentation

基　　金：上海市药品监督管理局2023年药品监管科学重大课题(ZD-2023-03)。

摘　　要：近年,随着政策激励以及生物医药产业迅速发展,上海市医疗器械独立软件注册申报数量持续增加,该研究对2020—2023年上海市医疗器械独立软件现场核查中所发现的规范不合格项进行了汇总统计,结果表明近70%为软件开发过程的问题。通过深入分析,针对软件需求、软件设计、软件测试、软件缺陷管理以及软件配置管理等问题出现最多的5个环节,结合软件开发特点,提出了相应的应对措施。这些建议措施对于医疗器械软件开发及质控人员、技术审评核查人员具有一定的参考意义。With the encouragement of policies and the rapid development of the biopharmaceutical industry,the number of software as medical device(SaMD)registration applications in Shanghai has continued to increase in recent years,and this paper summarizes the GMP nonconformities found in the field inspection of SaMD in Shanghai from 2020 to 2023,and the results show that nearly 70%of the problems were found in the software development process.Through in-depth analysis,this paper proposes the corresponding countermeasures for the problems found in the five most common stages such as software requirements,software design,software testing,software defect management and software configuration management,combined with the characteristics of software development.These suggested measures have certain reference significance for medical device software development and quality control personnel,and technical reviewer and inspectors.

关 键 词：医疗器械独立软件 软件生存周期 生产质量管理规范附录独立软件 现场核查 

分 类 号：R319[医药卫生—基础医学] F203[经济管理—国民经济]