Abstract: Background Digital Therapeutics（DTx），as an innovative digital interventional method，is internationally regarded as a prescription "digital drug" with significant potential in chronic disease management and mental health. China's "Healthy China 2030" strategy supports healthcare digital transformation. However，there's a lack of systematic analysis on DTx products approved by China's National Medical Products Administration（NMPA）. Also，there are challenges such as an imperfect regulatory framework and insufficient clinical evidence. Objective Conduct a systematic analysis of the characteristics of DTx products approved by the NMPA，systematically review approval trends，indication distribution，and industrial landscape，to provide evidence for regulatory policy optimization and industrial development. Methods Research data were primarily sourced from eight medical device databases of the NMPA. Using independent keyword searches，a total of 20 107 candidate devices were generated. After screening，235 devices meeting the definition of DTx were identified. Seventeen product features were extracted，and statistical analysis was performed using SPSS 25.0 software. Results As of December 2024，the NMPA had approved 235 devices that meet the definition of DTx. The number of approvals has increased yearly since 2018，with a significant increase in 2022. Most are domestically produced（n=227，96.6%）and approved（n=219，93.2%）by local medical products administrations. The majority are Class II medical devices（n=224，95.32%），with core functions mostly focused on disease treatment（n=207，88.09%），widely used for nervous system diseases（n=108，45.96%）. Nearly all require prescriptions（n=227，96.6%）and often use guided behavioral intervention techniques（n=135，57.45%）. Digital technologies mainly involve online medical services（n=145，61.70%）and primarily target the adult population（n=163，69.36%）. Manufacturers are mostly in economically developed regions. Conclusion China's DTx industry is growing due to policy support. But there are obstacles like an incomplete regulatory framework，insufficient evidence generation，and a lack of business models. It's suggested to enhance regulatory policies，emphasize real world evidence，and raise academic attention to support wider DTx adoption.

Key words: Digital therapeutics, Medical devices, Regulatory approval, Policy, National Medical Products Administration

摘要： 背景 数字疗法（DTx）作为一种创新的数字化干预手段，在国际上视为可处方的“数字药物”，在慢性病管理、精神健康等领域潜力显著。我国“健康中国 2030”战略支持医疗数字化转型，但当前缺乏针对我国国家药品监督管理局（NMPA）批准DTx产品的系统分析，且存在监管框架不完善、临床证据不足等挑战。目的 系统分析NMPA批准的DTx产品特征，梳理审批趋势、适应证分布及产业格局，为监管政策优化和产业发展提供依据。方法 本研究数据主要源于NMPA 8个医疗器械数据库。使用关键词独立检索，共产生20 107个候选设备，经筛选确定235个符合DTx定义的设备。提取17个产品特征，采用SPSS 25.0软件进行统计分析。结果 截至2024年12月，NMPA共批准235个符合DTx定义的设备，2018年起批准数量逐年增长，2022年显著增加。多数为国产设备（n=227，96.6%），主要由地方药品监督管理局批准（n=219，93.2%）。产品以第二类医疗器械为主（n=224，95.32%），核心功能多为治疗疾病（n=207，88.09%），在神经系统疾病领域应用最广泛（n=108，45.96%）。绝大多数需处方使用（n=227，96.6%），多采用指导性行为干预技术（n=135，57.45%）。数字技术以在线医疗服务为主（n=145，61.70%），主要面向成人（n=163，69.36%）。制造商集中于经济发达地区。结论 中国DTx产业呈政策驱动式增长，但存在监管体系待完善、临床证据生成不足、商业模式单一等瓶颈。建议完善监管政策，强化真实世界证据，提高学术界关注度，以支持更广泛地采用DTx。

关键词: 数字疗法, 医疗器械, 监管批准, 政策, 国家药品监督管理局