CHINESE JOURNAL OF MEDICINAL GUIDE >
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
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.
JIANG Xiao, DONG Qian, ZHANG Chunqing, ZHU Jiong
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Research and Exploration on the Naming of Digital
Therapeutic Medical Software
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