China Medical Device Industry Association's Digital Therapeutics Committee Holds Policy and Industry Forum in Tianjin Binhai New Area

On August 26, the digital therapeutics government-enterprise exchange event came to Tianjin Binhai New Area, where exchanges were conducted in the form of a closed-door seminar.

This symposium was hosted by the Digital Therapeutics Professional Committee of the China Association for Medical Device Industry (hereinafter referred to as the “Professional Committee”), co-organized by the Shanghai Institute for Medical Device Testing and the Administrative Committee of Tianjin Economic-Technological Development Area, and supported by the Tianjin Municipal Government Office for Cooperation and Exchange and the Tianjin Medical Products Administration. Representatives from more than 30 digital therapeutics companies, including Boehringer Ingelheim, Huawei Terminal, Tethys, Zheng’an Health, Yidu Cloud, and Zhilan Health, participated in the event.

This symposium was held withLocal Policy Support, Drug Regulatory Policies and Regulations, and Industry Dynamics for Digital Therapeutics ProductsCentered on this theme, and aimed at facilitating the substantive implementation of digital therapeutics (DTx) enterprises in China and enabling relevant government authorities to gain an in-depth understanding of DTx product characteristics as well as the regulatory review, approval, inspection, and testing of DTx-related medical devices, the event brought together leading domestic and international DTx companies and policy experts. Focusing on key niche sectors, the participants engaged in efficient, high-quality discussions and exchanges in a relaxed atmosphere.

Liu Chongsheng, Secretary-General of the Digital Therapeutics Committee

Mr. Liu Chongsheng, the Secretary-General Designate of the Special Committee, first introduced to the attending leaders an overview of digital therapeutics (DTx) and its development both in China and abroad. He noted that as DTx continues to evolve, the importance of product safety and efficacy, regulatory compliance, and medical evidence-based validity has become increasingly prominent.The Digital Therapeutics Professional Committee of the China Medical Devices Industry Association is the first association in China dedicated to digital therapeutic medical devices. Under the guidance of drug regulatory authorities at all levels, the Committee aims to promote the development of China’s digital therapeutics industry. Leveraging the technical expertise of the Shanghai Institute for Medical Device Testing and its two national-level key laboratories, the Committee conducts work in areas including technological research, standard setting, inspection and testing, clinical research, and regulatory and technical support.Empower the development and growth of companies in the digital therapeutics sector, contributing to the realization of China’s “Healthy China 2030” initiative and its “Long-Range Objectives Through the Year 2035.”

Director Xie Peng, Tianjin Municipal Office for Cooperation and Exchange

Mr. Xie Peng, Director of the Tianjin Municipal Office for Cooperation and Exchange, introduced an overview of Tianjin, its development strategy, and the advantages of its business environment. He promoted the industrial environment and preferential policies for enterprises in the Tianjin Economic-Technological Development Area (TEDA). Furthermore, he engaged in discussions with participating corporate representatives, aligning the dialogue with their respective business development situations.

Director Tang Lin, Tianjin Municipal Medical Products Administration

Director Tang Lin of the Tianjin Municipal Medical Products Administration introduced a series of preferential policies issued by the Administration to optimize the business environment and support the development of small, medium, and micro enterprises in the medical device sector. The presentation covered key topics, including pre-market research and development, key points for registration submission, review, and approval, post-market production and operation, and the sequential framework of comprehensive policies promoting the development of the medical device industry.

In addition, Boehringer Ingelheim, Terumo, and Orange Heart Medical also shared insights on industry developments.

Meng Xianhua, Medical Director, Boehringer Ingelheim

Meng Xianhua, Medical Director at Boehringer Ingelheim, shared insights on pharmaceutical companies’ exploration of digital therapeutics (DTx). She presented Boehringer Ingelheim’s comprehensive stroke solution based on DTx and highlighted the concerns of pharmaceutical companies within the DTx industry. She also expressed her hope that the association would further collaborate with regulatory authorities and more enterprises to jointly draft and develop a series of standards for digital therapeutics. She looks forward to further progress in China’s DTx sector in terms of classification, clinical evaluation, and communication.

Liu Chunfeng, Co-founder of Shanghai Tuhofen

Dr. Liu Chunfeng reviewed the development of the digital therapeutics (DTx) industry over the past two years and proposed that “the design and development of DTx products should be driven by user motivation, remaining engaging and goal-oriented beyond merely pursuing clinical efficacy.” The organic and robust integration of “efficacy” and “usability” in DTx products will consistently constitute the core competitive barrier for industry participants. Only on this foundation can a mature expert consensus specific to the DTx sector gradually take shape, alongside clear medical device registration pathways and solid, reliable commercialization models—these are currently the pivotal considerations in DTx product development.

Finally, as the organizer of this event, the Digital Therapeutics Committee of the China Medical Device Industry Association is committed to promoting the development of China’s digital therapeutics industry, with a particular focus on standard setting, technological innovation, clinical research, and testing and inspection of digital therapeutic products. Providing regulatory and technical consulting services is also a key priority of the Committee. As an advisory organization for VCBeat’s digital therapeutics industry initiatives, the Committee jointly released the “Global Digital Therapeutics Industry Report” with VCBeat in 2022, offering a systematic analysis of the market status, technological innovations, policy trends, product approval processes, and business models within the digital therapeutics sector from an industry perspective. According to reporters, the “First China Digital Therapeutics Product Quality and Regulatory Forum,” organized by the Committee, will soon be held at an appropriate time in the Yangtze River Delta region.