孟加拉国医疗软件监管现代化:基于风险的SaMD监管路线图
Nazma Akter Zinnia1, Eisuke Hanada2
1Graduate School of Science and Engineering, Saga University, Saga, 8408502, Japan. zinnia.cse7862@gmail.com.
Journal of medical systems
|January 14, 2026
概括
孟加拉国需要简化软件作为医疗设备 (SaMD) 的监管途径,以确保患者的安全. 本研究为药物管理总局 (DGDA) 提出了一份基于风险的半自动化路线图.
科学领域:
- 医疗器械监管法规 医疗器械监管法规
- 医疗信息学 医疗信息学
- 软件工程 软件工程 软件工程
背景情况:
- 软件作为医疗设备 (SaMD) 对医疗保健至关重要,但孟加拉国和其他低收入和中等收入国家 (LMIC) 缺乏量身定制的监管途径.
- 目前医疗软件批准的手动流程效率低下,不一致,并对患者安全构成风险.
- 高收入国家的现有框架 (IMDRF,欧盟MDCG,美国FDA) 为SaMD监管提供了模型.
研究的目的:
- 为孟加拉国药物管理总局 (DGDA) 批准SaMD提出一个半自动化,基于风险的摄入路线图.
- 为了解决与医疗软件当前手动监管流程相关的低效和安全风险.
- 提供一个有形的工作流程,用于对SaMD提交的分类,确定对人类审查和覆盖的需求.
主要方法:
- 借鉴国际框架 (IMDRF,欧盟MDCG,美国FDA,世卫组织).
- 开发一个半自动化,基于风险的采纳工作流程,用于SaMD提交.
- 定义关键的摄入领域,升级规则和绩效指标.
- 分析孟加拉国目前的DGDA背景和数字健康格局.
主要成果:
- 关于半自动化SaMD提交分类的建议工作流程,区分自动处理,人体审查和人体覆盖.
- 确定孟加拉国现有监管体系中的特定法律和基础设施缺口.
- 定义了DGDA的主要摄入领域,升级规则和可衡量的绩效指标.
结论:
- 拟议的路线图为孟加拉国SaMD监管的现代化提供了一个实际的解决方案.
- 这种分阶段的现代化方法可以提高医疗软件审批的效率,一致性和患者安全.
- 为孟加拉国开发的模型可以作为其他寻求建立SaMD监管途径的LMICs的宝贵指南.
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