中国数字疗法的发展现状与趋势：基于批准产品的多维度分析
Development and Trends of Digital Therapeutics Industry in China：a Multidimensional Analysis Based on Approved Products
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。
医学现状、医学发展医学研究方法
数字疗法医疗器械监管批准政策国家药品监督管理局
方琪川,梁俊,焦晓怡,刘勇成,张李芳,张华青,贺云帆,董雷,相鹏,雷健波.中国数字疗法的发展现状与趋势：基于批准产品的多维度分析[EB/OL].(2025-09-26)[2025-10-01].https://chinaxiv.org/abs/202509.00184.点此复制
Background Digital TherapeuticsDTxas an innovative digital interventional methodis 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. Howeverthere's a lack of systematic analysis on DTx products approved by China's National Medical Products AdministrationNMPA. Alsothere 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 NMPAsystematically review approval trendsindication distributionand industrial landscapeto 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 searchesa total of 20 107 candidate devices were generated. After screening235 devices meeting the definition of DTx were identified. Seventeen product features were extractedand statistical analysis was performed using SPSS 25.0 software. Results As of December 2024the NMPA had approved 235 devices that meet the definition of DTx. The number of approvals has increased yearly since 2018with a significant increase in 2022. Most are domestically producedn=22796.6%and approvedn=21993.2%by local medical products administrations. The majority are Class II medical devicesn=22495.32%with core functions mostly focused on disease treatmentn=20788.09%widely used for nervous system diseasesn=10845.96%. Nearly all require prescriptionsn=22796.6%and often use guided behavioral intervention techniquesn=13557.45%. Digital technologies mainly involve online medical servicesn=14561.70%and primarily target the adult populationn=16369.36%. 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 frameworkinsufficient evidence generationand a lack of business models. It's suggested to enhance regulatory policiesemphasize real world evidenceand raise academic attention to support wider DTx adoption.
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