Pioneer Dialogue on Digital Therapeutics Industry China Tour (Changsha Stop) Concludes Successfully

On September 23, the “Digital Therapeutics Industry China Tour” arrived in Changsha, Hunan Province, where it held the ninth edition of the series through a closed-door government-enterprise seminar and corporate site visits.

This event is organized byPreparatory Committee for Digital Therapeutics Systems Engineering, China Association for Promotion of Rehabilitation Technology Translation and Development(hereinafter referred to as the Preparatory Committee)VCBeat, Yuan Yi Capital, Sanofi (China), Viatris, Weimai, Qianglian Zhichuang, Fosun Pharma, Shanzhen, Takeda (China)Co-organized by,Tasly, Senmei Medical, Huanuo Zhisheng, Miao Health, Shukang, Yuanxin Medical Technology, Yuanxin Huibao Technology, Rendong Medicine, Tigermed Jietong, Liangyihui, Boston Tech, Guyitang, Jianhai Technology, Shuyao, Zhongke Zhikang, Jicheng Children's Dentistry, Zhi Lan Health, Shuyu Technology, Fangxin Technology, AffaMedCo-organizer,Yongliu Technology, Yunkai Yamei, Changling Capital, BlueRun Ventures, Shengshan Asset Management, Wangli Technology, China-Europe Science and Technology InnovationSupport.

Themed around the regulatory review and approval of AI-based medical devices and their industrial practices, this seminar focused on AI-based medical devices—a core area of digital therapeutics. It brought together leading Chinese digital therapeutics companies and policy experts to conduct efficient and high-quality discussions and exchanges centered on regulatory review, approval, and industrial implementation.

In his address, Song Wuchen, President-Elect and Executive Secretary-General of the China Association for Promotion of Rehabilitation Technology Translation and Development, stated that with the deepening research into artificial intelligence (AI), the integration of AI technology with medical devices represents a critical dimension in the evolution of the medical device industry. As a national-level platform for technology translation in the healthcare and wellness sector, the Association is committed to assisting central government ministries in formulating relevant industrial policies and supporting local governments in advancing the development of the healthcare industry. Guided by the mission of promoting the integrated development of industry, academia, and research within the healthcare sector, the Association strives to contribute to the construction of a Healthy China by integrating industrial resources and facilitating technology translation.

Song Wuchen, President-Elect and Executive Secretary-General of the China Association for the Promotion of Rehabilitation Technology Translation and Development

Peng Xuming, Deputy Director of the Hunan Provincial Medical Products Administration, noted that in recent years, Hunan Province has successively issued documents to deepen reforms in the review and approval system for medical devices, eliciting strong responses from the industry. He provided a brief introduction to the background and main content of the following documents: “Several Opinions of the General Office of the People’s Government of Hunan Province on Promoting the Innovative Development of the Biopharmaceutical Industry,” “Announcement on Further Advancing Relevant Matters Concerning the Reform of the Administrative Examination and Approval System,” and “Implementation Opinions of the Hunan Provincial Medical Products Administration on Earnestly Strengthening Safety Supervision of Medical Devices and Promoting High-Quality Development of the Medical Device Industry.” He also outlined the development prospects for artificial intelligence-enabled medical devices in Hunan Province.

Deputy Director of the Hunan Provincial Medical Products Administration, Peng Xuming

Yan Lihua, Deputy Director of the Medical Device Division of the Hunan Provincial Medical Products Administration, provided an analysis of the current status and development trends of China’s AI-driven healthcare sector, focusing on approval and regulatory policies for artificial intelligence. She introduced the Artificial Intelligence Medical Device Innovation Cooperation Platform established by the National Medical Products Administration (NMPA), which aims to encourage innovation and accelerate the translation and application of AI technological achievements in the medical device field. Furthermore, she analyzed the approval policies and regulatory framework for AI medical devices from the perspectives of the NMPA’s top-level design, industry scale, classification determination, and regulatory practices, and shared information on the industrial policies that Hunan Province is vigorously implementing to promote the development of AI medical devices.

Yan Lihua, Deputy Director of the Medical Device Division, Hunan Provincial Medical Products Administration

Wang Hui, Director of Division I, Department II, at the Hunan Provincial Center for Drug Evaluation and Adverse Reaction Monitoring, provided an in-depth analysis of the classification of AI-based medical devices. He covered key aspects such as the current development landscape, the three core elements, and classification principles. Additionally, he led discussions on critical focuses in research and validation—particularly regarding data quality and cybersecurity—and highlighted the differences in clinical evaluation between traditional medical device software and AI-based medical devices. Through numerous representative case studies, Director Wang offered concrete explanations of product classification and research validation, deeply reinforcing the core philosophy that “Standards Shape Quality, Professionalism Achieves the Future.”

Wang Hui, Director of Division 1, Department II, Hunan Provincial Center for Drug Evaluation and Adverse Reaction Monitoring

Wen-Zhe Liu, Founder and CEO of StrongLink AI®, introduced the company’s current focus on the vertical sector of intelligent diagnosis and treatment for cerebrovascular diseases. By addressing critical pain points in the treatment phase, the company has extended its services upstream to preoperative assessment, diagnosis, and screening, and downstream to patient follow-up and rehabilitation, thereby creating a closed-loop system for intelligent cerebrovascular disease management. Additionally, Mr. Liu engaged in discussions with attending experts regarding regulatory classification and commercial implementation of AI-based diagnostic and therapeutic solutions.

Liu Wenzhe, Founder and CEO of U-Brain®

Li Qiang, CTO of Gu Yitang, introduced the company’s explorations in digital health management systems. He also engaged in discussions with on-site experts regarding the construction of a platform ecosystem centered on comprehensive user needs and driven by business rules, as well as strategies for defining regulatory boundaries during the registration of medical devices or digital therapeutics.

Gu Yitang CTO Li Qiang

Qiu Yan, Partner at Bostech, discussed the company’s founding mission and development journey with attending enterprise representatives and expert leaders, and provided an overview of the current status of product registration.

Qiu Yan, Partner at Bositeng Technology

Cao Qun, General Manager of Xinjing Technology, provided a brief overview of the current status of product registration and approval for Xinjing Technology, and engaged in discussions with on-site experts regarding clinical indicators, design protocols, and other related issues.

Cao Qun, General Manager of Xinjing Technology

Huang Shengxiang, Director of Smart Healthcare Operations at Fangxin Technology, provided a brief overview of the company’s current product portfolio and elucidated the differences between its offline and online CBT-I (Cognitive Behavioral Therapy for Insomnia) solutions. He also engaged in discussions with the attending experts regarding the National Medical Products Administration’s (NMPA) new policies on software for adjunctive treatment of sleep disorders.

Huang Shengxiang, Director of Smart Healthcare Operations at Fangxin Technology

Liu Xue, Head of the Digital Clinical Research Division at Good Doctor Hui, provided a brief introduction to the company’s product portfolio and engaged in in-depth discussions with the attending experts on classification and determination, functional aspects, intended use, and the review and approval processes for standalone software and combination software.

Liu Xue, Head of the Digital Clinical Research & Digital Therapeutics Division at Liangyihui, and Director of Digital Business

Han Zhenya, Founder and CEO of BoSu Mian, shared insights on the company, its pulsed magnetic therapy system, and the registration strategy for the CBT product series. He also engaged in discussions regarding the classification of the CBT series and the use of overseas clinical data.

Han Zhenya, Founder and CEO of PaceSleep

Wang Ping, President of Snail Sleep Medical Health, introduced the product’s development history and technical advantages, and conducted an in-depth discussion on current issues regarding Snail Sleep products, such as classification delineation and software registration updates for hardware management.

Wang Ping, President of Medical and Healthcare at Snail Sleep

Bai Yun, Regulatory Affairs Manager at Zhizhong Technology, provided an overview of the company’s integrated solutions covering “clinical trials, technical regulations, inspection and testing, contracted R&D, and industry incubation.” He also engaged in discussions with on-site experts on issues related to product testing, clinical research, and innovation pathways.

To Bai Yun, Regulatory Affairs Manager at Zhongzhong Technology

The 9th Edition of the Digital Therapeutics Industry Tour in China Arrives in Changsha, Hunan, Conducting a Site Visit at Gu Yitang, a Representative Local Member Enterprise

Mr. Yang Jichang, Founder and Chairman of the Group, introduced the company’s development history, business model, corporate culture, and win-win cooperation. He provided a detailed interpretation of the corporate mission of “Technology-Driven TCM for National Health,” the corporate vision of “Building an Integrated Health Management Service Platform,” and the current strategic positioning and business model focused on “out-of-hospital chronic disease and sub-health management.” Visiting Corporate LeadersDiscussions were held on Guyitang’s development model, cooperation opportunities, and resource sharing.

Gutang (Hunan) Health Technology Co., Ltd. was established in 2014 as the first local enterprise in Hunan Province to obtain an Internet Hospital license and is recognized as a High-Tech Enterprise of Hunan Province. The company has independently developed a TCM-characteristic Internet Hospital platform, a health big data platform, a health management system, a Clinical Decision Support System (CDSS), and an intelligent service and quality control system, striving to build the most influential comprehensive health management service platform. It has initially formed an industrial ecosystem encompassing Internet hospitals, health big data, artificial intelligence, chains of TCM clinics and pharmacies, as well as the R&D, production, distribution, and retail of pharmaceutical and health products. Furthermore, it has achieved considerable scale in constructing knowledge, product, and service systems for women’s health conditioning, men’s health conditioning, sub-health management, and chronic diseases such as diabetes.