China Medical Device Industry Association Digital Therapeutics Committee Officially Launched to Promote High-Quality Development and Regulatory Compliance
On October 28, 2022, hosted by the Digital Therapeutics Professional Committee of the China Association for Medical Device Industry and undertaken by the Shanghai Institute for Medical Device TestingInaugural Conference of the Digital Therapeutics Professional Committee of the China Medical Devices Industry Association & The 1st China Digital Therapeutics Product Quality and Regulatory ForumConcluded successfully in Shanghai.
This conference focuses on global standards and regulatory policies for digital therapeutics, integrating the actual development status of domestic digital therapeutics companies. It has invited relevant leaders from the Shanghai Municipal Medical Products Administration, the Yangtze River Delta Branch of the Center for Technical Review and Inspection of Medical Devices under the National Medical Products Administration, and the Shanghai Institute for Medical Device Testing; leaders from the China Association for Medical Devices Industry; representatives from its Digital Therapeutics Professional Committee; and experts from renowned domestic and international organizations such as UL and BSI to participate jointly.
To promote the high-quality development of digital therapeutics in China and facilitate the substantive participation of Chinese digital therapeutics enterprises in standardization efforts,The Digital Therapeutics Professional Committee of the China Medical Devices Industry Association, the first association in China dedicated to digital therapeutics medical devices, was officially established on the day of the event.. Under the guidance of drug regulatory authorities at all levels, the Special Committee aims to promote the development of China’s digital therapeutics industry. Leveraging the technical support of the Shanghai Institute for Medical Device Testing and its NMPA Key Laboratory, the Committee will carry out work in scientific research, standard setting, inspection and testing, clinical studies, and regulatory support.
Group Photo of Attendees at the Inaugural Meeting of the Digital Therapeutics Professional Committee of the China Medical Device Industry Association
Inaugural Meeting Phase,Yu Hongyi, President of Shanghai Institute for Medical Device TestingIn his opening remarks, he first introduced the functions of the Institute of Medical Devices, as well as its research experience and achievements in digital therapeutics. He pointed out that in the future, the Institute will undertake the administrative tasks of the Digital Therapeutics Professional Committee, continue to conduct in-depth research on standards, consensus, and testing methods for digital therapeutic products, and contribute to the robust development of digital therapeutics.
Yu Hongyi, President of the Shanghai Institute for Medical Device Testing
Xu Shan, Secretary-General of the China Association for Medical Device IndustryIn his address, he stated that industry associations serve as efficient platforms for fostering exchange among industry, academia, research, and healthcare sectors. As a key branch of the parent association, the Digital Therapeutics Committee will leverage its platform advantages and resources to strengthen communication and collaboration, thereby promoting cross-sectoral interaction among industry, academia, research, healthcare, inspection agencies, government, and enterprises. The industry association will also represent and safeguard the common interests and legitimate rights of its member units, contributing to the healthy development of China’s medical device industry.
Xu Shan, Secretary-General of the China Association of Medical Device Industry
Li Yaohua, Director of the Yangtze River Delta Branch Center for Technical Review and Inspection of Medical Devices, National Medical Products AdministrationDirector Li emphasized that regulatory oversight is the top priority for the development of the digital therapeutics (DTx) industry. He clarified the critical role of standards in the review and approval process, highlighting their importance in enforcing corporate accountability and ensuring the quality of DTx products. He affirmed the Shanghai Institute of Medical Device Testing’s leading position within the industry. Director Li expressed his expectation that the Digital Therapeutics Professional Committee will serve as a bridge and link to jointly advance the standardization of digital therapeutics.
Li Yaohua, Director of the Yangtze River Delta Branch Center for Technical Review and Inspection of Medical Devices, National Medical Products Administration
Deputy Director Guo Shuting of the Shanghai Municipal Medical Products AdministrationDelivered a speech at the conference, highlighting the significant importance of establishing the Digital Therapeutics Professional Committee and outlining industry expectations. In his address, Director Guo emphasized that the Committee should serve as a bridge between regulatory authorities and the industry, fulfill its mission with responsibility, effectively carry out all its duties, promote compliant development of the digital therapeutics sector, and provide quality services to its member units.
Deputy Director of the Shanghai Municipal Medical Products Administration, Guo Shuting
On the day of the event, through an online voting process,He Jun, Party Secretary and Vice President of the Shanghai Institute for Medical Device Testing, was elected as Chairman of the Digital Therapeutics Professional Committee of the China Association for Medical Devices Industry. Liu Chongsheng, Director of the Software and Cybersecurity Division at the Shanghai Institute for Medical Device Testing, was elected as Secretary-General of the Committee.Boehringer Ingelheim (Shanghai) Health Management Co., Ltd., Changchun GeneScience Pharmaceuticals Co., Ltd., Chongqing VCBeat Technology Co., Ltd., Sinopharm-Reed Exhibitions Co., Ltd., Hangzhou Zhilan Health Co., Ltd., Huawei Device Co., Ltd., Viatris Pharmaceuticals Co., Ltd., ResMed (Beijing) Trading Co., Ltd., Shanghai Tehuofen Intelligent Technology Co., Ltd., Shenzhen Zheng’an Health Technology Co., Ltd., Suzhou Yiduoyun Health Co., Ltd., Infervision Medical Technology Co., Ltd., Abbott Trading (Shanghai) Co., Ltd., Yidu Cloud (Beijing) Technology Co., Ltd., BaseBit.ai, and Zhejiang Zhisheng Technology Group Co., Ltd.—a total of 16 member organizations—were elected as Vice-Chairman Units of the Digital Therapeutics Special Committee, while another 49 companies involved in digital therapeutics were elected as Standing Committee Member Units.
Group Photo of the First Chairman, Vice Chairmen (Partial), and Secretary-General of the Digital Therapeutics Professional Committee of the China Medical Devices Industry Association
He Jun, First Chairman of the Digital Therapeutics Professional Committee of the China Medical Device Industry AssociationThe Chairman delivered a speech. He stated that the medical ecosystem for diagnosis, treatment, and rehabilitation built upon digital therapeutics can effectively alleviate the burden on healthcare institutions, improve patient cure rates, and enhance quality of life post-recovery. The Digital Therapeutics Professional Committee will concretely implement various initiatives—including training and technical cooperation, policy and technical support, and research on industry consensus—within the scope of the parent association’s business activities.
He Jun, First Chairman of the Digital Therapeutics Professional Committee of the China Association for Medical Device Industry
Liu Chongsheng, Secretary-General of the Special CommitteeStatement by the Secretary-General: During my tenure, I will strictly abide by the rules and regulations of the China Medical Device Industry Association. Under the leadership and policy guidance of the Chairman, I will maintain close coordination with the Vice-Chairmen and member units. Leveraging the robust technical foundation and expertise of the Shanghai Institute for Medical Device Testing, I will provide regulatory technical support for medical device products utilizing digital therapeutics. Furthermore, I will strive to create opportunities for communication among all sectors of society, serve as a bridge and link, integrate resources from various parties, and explore pathways for consensus-building.
At the inaugural China Digital Therapeutics Product Quality and Regulatory Forum, renowned overseas institutions and leading domestic and international enterprises shared insights on digital therapeutics policies and regulations, innovative technologies, industry trends, and registration experiences.
As a representative of the Digital Therapeutics Professional Committee of the China Medical Device Industry Association,Secretary-General Liu ChongshengAn introduction was provided on the scope of business and activity planning of the Digital Therapeutics Special Committee, along with a report on the progress of digital therapeutics standardization work. The framework for digital therapeutics standards was released, and it was announced that the Special Committee would further refine the standard research working groups, improve the standardization framework, and take the lead in organizing the drafting of relevant standards.
Liu Chongsheng, Secretary-General of the Digital Therapeutics Professional Committee, China Medical Devices Industry Association
Zhang Bo, Manager of Medical Business Development, UL Asia-PacificThis article introduces U.S. regulations on digital health and telemedicine, affirming the critical role of digital therapeutics (DTx) products in telemedicine. It further emphasizes interaction modalities during product development, as well as product safety and efficacy, providing references for the research, development, and design of DTx-related products in China.
Zhang Bo, Manager of Medical Business Development, UL Asia-Pacific
Ji Lifang, Director of Medical Device Business, BSI ChinaA brief overview was provided on the definition and scope of digital therapeutics in Germany, as well as the evaluation methods for digital therapeutic products. Furthermore, UK digital health regulations and relevant EU legislation were introduced to offer a more in-depth interpretation of digital therapeutics.
Ji Lifang, Director of Medical Device Business, BSI China
In addition, Yifang Health Data, Zhilan Health, GeneScience Pharmaceuticals, Yidu Cloud, Zheng'an Health, Boehringer Ingelheim, and Teva alsoShared insights on the current state and dynamics of the industry, R&D and regulatory registration experience, and the technical features of digital therapeutics.
Li Weigang, President of the Medical and Healthcare Business Group at Yifang Health DataIt stated that throughout the entire lifecycle of digital therapeutics—encompassing R&D, manufacturing, and regulatory oversight for clinical application—every stage is closely intertwined with “data.” By leveraging full-stack technologies based on privacy-preserving computation, Yifang Jianshu provides end-to-end solutions grounded in security and privacy protection for medical application scenarios, thereby safeguarding data assets and model integrity while unlocking the value of data.
Gao Yunlong, General Manager of Zhilan HealthHe believes that digital therapeutics require strong integration capabilities in medicine and R&D, and that industry rules and standards must be well-established throughout this process. Furthermore, he stated that digital therapeutics can integrate many existing out-of-hospital hardware and testing products used for disease intervention and treatment, thereby opening up new avenues for production. By deeply integrating its own product and platform expertise with customers’ market needs and ecosystem, Zhilan Health enables demand-driven enterprises to accelerate into the “fast lane” of digital therapeutics through an “ecosystem-linking” approach.
Xian Xuan, Chief Information Officer of GeneScience Pharmaceuticals & Dean of the Digital Medical Research InstituteSharing Insights on Digital Applications in the Field of Child Growth and Development. Xian Xuan believes that in their digital transformation, pharmaceutical companies should first achieve informatization management across all business segments and data visualization. The second step is to focus on real-world clinical issues and patient benefits, collaborating with experts, leading medical institutions, and innovative enterprises to establish advanced standards for treating pediatric diseases. This includes developing digital therapeutics for conditions such as childhood obesity and attention-deficit/hyperactivity disorder (ADHD), thereby addressing gaps in the treatment of related disorders within China’s child growth and development sector.
Ma Lan, Head of Regulatory Affairs at Yidu CloudSharing insights on regulatory frameworks for registration and filing, Ms. Ma Lan emphasized that product compliance is a critical component throughout the entire process of digital therapeutics (DTx), from concept to commercialization. Regulatory requirements should be integrated into the product across its full lifecycle, and the effective operation of a quality management system should ensure the compliance of inputs and outputs at each stage. Both domestic and foreign regulatory authorities focus on the quality of product development historical documentation, as well as evaluations of cybersecurity and product usability.
Liu Xiaogang, Founder and CEO of Shenzhen Zheng'an HealthHe shared insights on the application of digital therapeutics in insomnia disorder. He stated that Cognitive Behavioral Therapy for Insomnia (CBT-I) is one of the optimal treatments for chronic insomnia, yet relevant therapeutic resources are scarce; digital therapeutics can effectively address this shortage. Furthermore, Liu Xiaogang believes that digital therapeutics constitute a comprehensive service solution rather than merely a single tool. The first domestic digital therapeutic product for chronic insomnia, launched by Zheng’an Health, has been effectively validated in clinical trials.
Meng Xianhua, Head of the Medical Department, Boehringer Ingelheim Health Innovation DivisionA presentation was delivered on the topic of pharmaceutical companies’ exploration of digital therapeutics, highlighting Boehringer Ingelheim’s comprehensive stroke solution based on digital therapeutics and its Jida Digital Rehabilitation products. Meng Xianhua stated that the research and development of digital therapeutic products must be grounded in patients’ actual needs, enabling them to benefit within a very short timeframe.
Liu Chunfeng, Co-founder of TechovonA Sharing on the Global Development Trends of Digital Therapeutics. Dr. Liu reviewed the trends in the number of clinical trials for digital intervention products in the digital therapeutics industry and proposed three directions for the development of digital therapeutics products: more disease indications, broader patient populations, and newer technologies. Dr. Liu Chunfeng stated that he hopes data can be standardized, suggesting that in the future, data could serve as a person’s digital phenotype, offering significant potential for the diagnosis, treatment, and monitoring of diseases.
According to incomplete statistics from VCBeat, more than 200 companies in China have entered the digital therapeutics field, with the initial spark now growing into a prairie fire. The formal establishment of the Digital Therapeutics Professional Committee under the China Association of Medical Device Industry will also accelerate the development of China’s digital therapeutics industry, leveraging its strong technical foundation to provide robust technical support for the regulatory oversight of related medical devices.