Zhilan Health Digital Therapeutics Webinar Series: Insights on Medical Device Registration and Clinical Research

In recent years, the digital therapeutics industry has shown broad prospects and rapid development. Before entering the market, the primary step for digital therapeutics is product registration. Currently, some digital therapeutics products in China have obtained domestic medical device registration certificates. However, in the absence of specific regulatory frameworks and standards for digital therapeutics at present, the path to obtaining medical device registration certificates remains fraught with uncertainty for most digital therapeutics products.

Against the backdrop of the release of the new Regulations on the Supervision and Administration of Medical Devices, the 2022 revised Guidelines for the Registration Review of Medical Device Software, and the Guidelines for the Registration Review of Cybersecurity in Medical Devices, it is necessary to introduce relevant regulatory policies for the development of the digital therapeutics industry. Furthermore, manufacturers of digital therapeutics must clarify their strategies during the medical device registration process.

Digital therapeutics (DTx) products in China play a pivotal role in the conduct of clinical trials. Amid the impact of the COVID-19 pandemic, the digital transformation of clinical research has accelerated, and researchers have placed greater emphasis on data quality in post-marketing studies.

Hereby,VCBeatJoin HandsSLANHEALTHIntroducing to EveryoneDigital Therapeutics Course Series: [Medical Device Registration] and [Clinical Research] Project Execution Courses. We hope to engage in joint discussions with all parties through two online sharing sessionsThe Unique Aspects of Digital Therapeutics in Medical Device Registration and Post-Market Clinical Studies: Providing New Regulatory Pathways and Pioneering Novel Clinical Research Models for Enterprises

[SLANHEALTH Digital Therapeutics] Two-Part Course Series

Course Dates: August 10, 2022; August 16, 2022

[Issue 1: Sharing on the Characteristics and Challenges of Digital Therapeutics in Medical Device Registration]

Event Time: August 10, 2022, 15:00-16:00

Format: Live Online Broadcast

Guest Speaker: Ma Le'an, Senior Registration Manager at SLANHEALTH

[Phase II: Sharing Clinical Research Models for Digital Therapeutics]

Event Time: August 16, 2022, 15:00-16:00

Format: Online Live Stream

Guest Speaker: Lu Lu, Clinical Project Manager at SLANHEALTH

Ma Lean, Senior Registration Manager, SLANHEALTH

Senior Registration Manager at SLANHEALTH, with many years of experience in medical device registration. Possesses extensive domestic and international experience in the registration and clinical application of active medical devices. Well-versed in the registration of standalone medical software and digital therapeutics (DTx) products, and contributed to provincial Medical Products Administration reports on digital therapeutics. Established a comprehensive methodology for DTx product registration, specializing in formulating and executing registration strategies, as well as liaising with review experts.

Lu Lu, Clinical Project Manager at SLANHEALTH

Clinical Research Project Manager. Since 2016, has been involved in the Phase I (1,000 cases) and Phase II (nearly 40,000 cases) of the “Zero Mother-to-Child Transmission of Hepatitis B” project, as well as the entire process of regulatory submission and registration for the “Little Shell” digital therapeutic. Possesses three years of frontline clinical experience and three years of clinical research project management experience. During this period, participated in a prospective cohort study of 600 cases under the National Key R&D Program of China during the 13th Five-Year Plan period. Focuses on all stages of clinical research, from project initiation, ethics review, execution, and data governance to statistical analysis, striving for the highest project quality.

As a pioneer in China’s digital therapeutics (DTx) industry, SLANHEALTH primarily provides CDMO and end-to-end services for digital therapeutics. By assembling a multidisciplinary team of composite talents, the company precisely identifies clinical needs. Leveraging its proprietary digital intelligence platform and global partnerships, SLANHEALTH helps clients efficiently develop customized, clinically validated software solutions for disease diagnosis, treatment, and management, while delivering comprehensive end-to-end services. This approach ensures legal and regulatory compliance, reduces costs, and enhances efficiency, enabling rapid product commercialization and broad reach to end users.

SLANHEALTH’s digital therapeutics CDMO and end-to-end services include: medical protocol design, product design and R&D, pilot-scale translation, clinical trials, regulatory registration services, commercialization operations, and real-world evidence studies.

“VB Think Tank” is one of VCBeat’s flagship events, serving as a face-to-face platform centered on exploring solutions in the healthcare sector, with the aim of “focusing on practical challenges and discussing industry trends.” The event conducts in-depth discussions, analyses, and idea exchanges around the current development status of core themes, addressing encountered difficulties, pain points, and obstacles. Meanwhile, it delves into the resource endowments of participating enterprises, fostering practical collaborations through intellectual exchange.