VB ThinkTank Launches 'Medical Device Lifecycle' Educational Series Amid Regulatory Evolution
In recent years, the Marketing Authorization Holder (MAH) system for medical devices has become a “hot topic” in China’s medical device industry. This surge in attention is primarily attributable to the disruptive innovations and transformative changes introduced by the system across the industrial landscape. The newly revised Regulations on the Supervision and Administration of Medical Devices are regarded as the most stringent in history. Concurrently, the Measures for the Supervision and Administration of Medical Device Production and the Measures for the Supervision and Administration of Medical Device Distribution were revised and promulgated. These two measures rigorously implement the national requirements for “the most rigorous standards, the strictest supervision, the severest penalties, and the most serious accountability,” as well as the provisions of the new Regulations. They strengthen supervisory inspection measures, improve supervisory inspection methods, consolidate the primary responsibility of enterprises, and further increase penalties for illegal activities.
To enable enterprises to better comply with regulatory requirements for compliant development and fully enjoy the industrial dividends released by the system.VCBeat will join forces with Dongmai Medical Group, experts from the National Medical Products Administration’s Institute of Executive Development, and senior specialists formerly affiliated with the Jiangsu Provincial Institute for Medical Device Testing.LaunchTwo Issues on “Full Lifecycle of Medical Devices”Knowledge Point Series Public Welfare Course。
This course takes a holistic view of the entire lifecycle of medical device products, focusing in depth on two highly pertinent topics: how to manage risks at each stage of the regulatory approval pathway, and intellectual property protection under the Medical Device Registrant System. Through live streaming sessions, we aim to provide practical assistance to enterprises, helping them understand how to fulfill their legal responsibilities for product quality throughout the medical device lifecycle and safeguard the intellectual property rights of registrants.
【Medical Device Full Lifecycle】 Series of Public Welfare Courses
Course Dates: June 14, 2022 and June 16, 2022
[Lecture 1:New Models of Medical Device Manufacturing and Intellectual Property Protection in Light of Regulatory Changes】
Course Time: June 14, 2022, 14:00–15:00
Guest Speaker:Shanghai University of Medicine & Health Sciences, Major in Medical Product Management(Department) Director Associate Professor Jiang Haihong
Course Format: Live Online Session (Add the assistant to join the group chat and register for the course)
Dr. Chen Tao
Chairman of Dongmai Medical Group; Ph.D. in Acoustics from Nanjing University; Senior Engineer at Researcher Level; Master’s Supervisor at the University of Shanghai for Science and Technology; Visiting Professor at Shanghai University of Medicine & Health Sciences; Member of IEC/TC29; Chairman of the Medical-Engineering Translation Professional Committee of the Jiangsu Society of Biomedical Engineering. Selected as an Academic Leader for Young and Middle-aged Scholars under Jiangsu Province’s “333 Project”; Distinguished Talent in Healthcare of Jiangsu Province; Gusu Entrepreneurial Talent of Suzhou; Leading Entrepreneurial Talent of Suzhou New District. From 2003 to 2017, worked at the Jiangsu Institute for Medical Device Testing, serving as Director of the Active Devices Laboratory (Electrical Safety Laboratory). Previously served as General Manager of a medical device CRO group and founded a third-party testing technology company.
Published over 20 academic papers, including 6 indexed by SCI and 12 in core journals. Drafted five national standards, industry standards, and verification regulations; served as the lead author for the national standard GB/T 25102.8-2017 on hearing aids. Granted four invention patents and five utility model patents. Presided over one provincial/ministerial-level scientific research project and participated in two others.
Associate Professor Jiang Haihong
Executive Dean of Dongmai Academy, Dongmai Medical Group; Director and Associate Professor of the Medical Product Management Program (Department) at Shanghai University of Medicine & Health Sciences; Senior Consultant and Practicing Lawyer at Shanghai Yingtai Law Firm. Expert Consultant for Civil and Administrative Cases at the Supreme People’s Procuratorate; Founder and Head of China’s first undergraduate program in medical device management; Editor-in-Chief of the “13th Five-Year Plan” textbooks published by the National Health Commission; Deputy Editor-in-Chief of the Blue Book Series on Chinese Medical Devices. Independent Director of Jiangxi Sanxin Medtec Co., Ltd. and Jiangsu Dongxing Smart Medical Technology Co., Ltd.
A pioneering academic in China who systematically researched medical device policies and regulations, and a key initiator of the Shanghai Medical Device Registrant System. He/She was deeply involved in the revision of major regulatory documents, including the Regulations on the Supervision and Administration of Medical Devices, the Measures for the Administration of Medical Device Registration, the Measures for the Supervision and Administration of Medical Device Production, and the Measures for the Supervision and Administration of Medical Device Operation. He/She serves as a committee member for several organizations, including the National Medical Products Administration’s Advanced Training Institute, the China Association for Drug Regulatory Science, the China Medical Devices Industry Association, the China Medical Equipment Association, and the Shanghai Medical Devices Industry Association. He/She has delivered over 100 speeches and reports to drug regulatory authorities, industry associations, and enterprises. As legal counsel to multiple large-scale medical device companies, he/she possesses more than ten years of experience in providing legal services to the industry.
Dongmai Medical Group
Dongmai Medical Group was established in 2019, the inaugural year of China’s Medical Device Registrant System. It is one of the few comprehensive CDMO+CRO platforms in China capable of providing full lifecycle services for medical device products.
Medical Device Production License
ISO Certificate
The Group has established several one-stop industrial service bases in Suzhou, Wuxi, Nanjing, Changsha, and other locations. It operates multiple active production lines, Class 100,000 cleanrooms, and high-end medical device production workshops (Class 10,000 with local Class 100 areas), and has obtained ISO 13485 system certification. Additionally, the Group has built a testing and validation center compliant with ISO/IEC 17025. The platform covers an area of over 10,000 square meters.
Field Map and Detection Center Map
The Group has deeply engaged in the study of regulations concerning Medical Device Registrants, establishing a robust and time-tested collaboration model between registrants and entrusted manufacturers. In early 2021, the Group became the first CDMO platform in Jiangsu Province to obtain a Medical Device Production License. Leveraging mature capabilities in innovation translation and entrusted production management, the Group provides clients with a comprehensive suite of professional services, including quality system guidance, compliant development, engineering translation, contract manufacturing, testing and inspection, clinical evaluation, and regulatory registration consulting, thereby facilitating clients’ rapid achievement of industrialization goals.
Suzhou Base
Wuxi Base
Changsha Base
About VB Insight Salon
“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 mission to “focus on practical challenges and discuss industry trends.” The event conducts in-depth discussions, analyses, and exchanges on the current state of development around core themes, addressing encountered difficulties, pain points, and barriers. Meanwhile, it delves into the resource endowments of participating enterprises, fostering tangible collaborations through intellectual exchange.
About VB Open Course
“VB Open Course” is a branded column launched by VCBeat’s “VB Think Tank,” designed to create a high-value platform for outstanding healthcare innovation enterprises targeting the B2B market. The platform integrates knowledge sharing with marketing and sales enablement, helping companies achieve more efficient value delivery.