数字疗法类医用软件命名研究与探索
收稿日期: 2025-10-29
修回日期: 2026-03-30
录用日期: 2026-06-28
网络出版日期: 2026-08-17
基金资助
Research and Exploration on the Naming of Digital Therapeutic Medical Software
Received date: 2025-10-29
Revised date: 2026-03-30
Accepted date: 2026-06-28
Online published: 2026-08-17
目的：针对数字疗法类医用软件开展探索性的命名规范研究，为我国数字疗法产品的科学命名提供借鉴和参考，助力产业高质量发展。方法：通过梳理数字疗法的定义、范围、技术特点，检索全球医疗器械术语系统（GMDN）、欧洲医疗器械命名系统（EMDN）、美国食品药品管理局（FDA）有关典型数字疗法产品的命名情况，归纳分析国际监管机构对于数字疗法产品的命名监管现状，结合数字疗法产品的技术特点和我国医疗器械通用名称命名规则，探索数字疗法医用软件在我国的规范命名。结果与结论：目前，数字疗法尚属于新兴技术，处于高速发展中。国际监管机构通常将数字疗法产品纳入医疗器械监管范围，但是对于其命名尚未有统一的标准或认知。参照国际医疗器械命名数据库中数字疗法产品的案例，在我国现行医疗器械命名管理框架下，结合数字疗法产品的技术特点，针对不同类型的数字疗法产品提出通用名称、核心词和特征词的具体命名建议，旨在为相关医疗器械研发和监管提供技术支撑。
江潇
,
董谦
,
张春青
,
朱炯
.
数字疗法类医用软件命名研究与探索
Objective： To conduct an exploratory study on the naming specifications for medical software in the field of digital therapeutics， to provide a reference for the scientific naming of digital therapeutic products in China and support the high-quality development of the industry.Methods： By sorting out the definition， scope and technical characteristics of digital therapeutics， and reviewing the naming information of typical digital therapeutic products in the Global Medical Device Nomenclature （GMDN）， European Medical Device Nomenclature （EMDN） and the U.S. Food and Drug Administration （FDA）， this study summarized and analyzed the current regulatory status of naming conventions for digital therapeutic products among international regulatory authorities. Combined with the technical features of digital therapeutic products and China’s naming rules for generic names of medical devices， this study explored standardized naming schemes for digital therapeutic medical software in China.Results and Conclusion： Digital therapeutics is still an emerging technology in a stage of rapid development. At present， international regulatory agencies usually regulate digital therapeutic products as medical devices， and there is no unified standards or consensus for their naming yet. Based on cases of digital therapeutic products in international medical device nomenclature databases， and under China’s existing medical device naming regulatory framework， this study proposes specific recommendations on the generic names， core terms and characteristic terms for different types of digital therapeutic products， and to provide technical support for the research and development as well as regulation of related medical devices.
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