Zhizhong Medical Device Testing Institute and CMO Platform Officially Launched, Gathering 200 Industry Leaders to Discuss Trends and Regulatory Insights

VCBeat (WeChat ID: vcbeat) has learned that recently, jointly hosted by the China Association for Medical Device Industry and Wuhan Zhizhong Technology Co., Ltd.“The 3rd Summit Forum on Medical Device Registration Inspection and Post-Market Surveillance & Inauguration Ceremony of the Zhizhong Medical Device Testing Institute and CMO Platform”Successfully concluded.

At this grand event, more than ten industry leaders and experts fromNew Trends, New Regulations, and New Oversight in the Medical Device Industryshared insights with over 200 attendees from across China, while also showcasing the meticulously crafted solutions by Zhongzhi TechnologyZhongzhong Medical Device Inspection and Research Institute and Zhongzhong Medical Device Manufacturing CenterIt also unveiled its mysterious veil today.

Around 9:00 a.m., the attending guests traveled by bus to the Zhizhong Medical Device Testing and Research Institute and the Zhizhong Medical Device Manufacturing Center, located in the Software New City.

As the first innovation and entrepreneurship service platform in China dedicated to the technological translation of medical devices, Zhizhong leveraged its seven-plus years of industry resources, client reputation, internal systems, technical talent reserves, and insights into regulatory trends. Since early 2017, through project planning, site selection, bidding, design, and construction, Zhizhong has officially completed the first phase of its Medical Device Testing Research Institute and Manufacturing Center. Covering nearly 7,000 square meters, the facility houses five major laboratories—Electromagnetic Compatibility (EMC), Electrical Safety, Environmental and Reliability Testing, Sterile Packaging Testing, and Cleanroom Testing—as well as three production lines for active medical devices, sterile products, and diagnostic reagents. It provides integrated solutions for medical device R&D and manufacturing enterprises, spanning from design and development and regulatory compliance consulting to post-market production.

Industry Experts and Leaders Visit Zhizhong Medical Device Inspection Institute and Medical Device Manufacturing Center

At 11:00 a.m., attendees returned to the Sinopharm Building for the completion ceremony. Liu Lili, Secretary of the General Party Committee and Executive Deputy Director of the Comprehensive Management Office of Wuhan Optics Valley Modern Service Industry Park; Zhang Quan, Chairman of Wuhan Optics Valley Financial Holding Group Co., Ltd.; and Chen Lei, Managing Partner of Boying Capital, delivered opening remarks to congratulate the inauguration of the Zhizhong Medical Device Testing Research Institute and its manufacturing platform.This is a key technical support platform for the medical device industry in Optics Valley Bio-city, and also a testament to the development of the medical device sector in Optics Valley.

They each expressed their great pleasure in participating in the realization of Zhizhong’s dream to build an ecosystem service system for the technological translation of medical devices, and in witnessing every milestone of Zhizhong’s journey from its inception to its current development. With the expansion of market size, institutional reforms, and industrial upgrading, they believe that Zhizhong will achieve leapfrog development in the future. They will continue to provide support and assistance in various aspects to help Zhizhong achieve its goal of being based in Optics Valley, expanding beyond Wuhan to reach the entire Chinese market and ultimately the global stage, thereby becoming a globally recognized leader in the medical device industry.

Liu Lili, Secretary of the General Party Committee and Executive Deputy Director of the Construction and Management Office of Wuhan Optics Valley Modern Service Industry Park

Zhang Quan, Chairman of Wuhan Optics Valley Financial Holding Group Co., Ltd.

Chen Lei, Managing Partner of Boxing Capital

In his opening remarks, Zeng Jianhui, Chairman of Zhongzhong Technology, first stated that without the Optics Valley Bio-city, there would be no Zhongzhong; and without the selfless trust, assistance, support, and diligent efforts of industry leaders, experts, corporate partners (clients), and especially every member of the Zhongzhong team (including former colleagues), Zhongzhong would not have achieved its present success.

From a four-person team driven by dreams to a platform-based enterprise with nearly 80 employees and close to 8,000 square meters of facilities, Zhizhong owes its growth to the dedication and hard work of our team and their families. We are deeply grateful for the strong support and assistance provided by the East Lake Development Zone, Optics Valley Bio-City, the Modern Service Industry Park, and relevant government departments. “Zhizhong has come this far because so many people have helped us. The best way to repay them is to strive to run our company well and help more businesses succeed.”

To Zeng Jianhui, Chairman of Zhongzhong Technology

Chairman Zeng Jianhui also candidly stated that, from this point forward, Zhizhong has officially entered the more arduous second phase of its entrepreneurial journey, as large-scale facilities and a large workforce do not necessarily equate to competitive strength or advantage.Zhizhong’s true core competitiveness lies in the trustworthy and secure team it has been diligently building over the years under its “Credit Talent Development System,” consistently adhering to the principle of “seeking out individuals who mutually like and appreciate one another, to jointly engage in work that is both enjoyable and meaningful.””. How far Zhizhong can go in the future depends on generations of young Zhizhong employees, and on their contributions to and influence within the industry community.

Liang Yong, General Manager of Wuhan Software New City Development Co., Ltd. (left), and Xu Peng, Deputy General Manager of Zhizhong Technology (right), unveiled the plaque for the “Optics Valley Medical Device Innovation Promotion Platform.”

Guo Lei, Board Secretary and Director of the Mass Innovation Business Division at Zhihong Technology, stated while introducing the medical device technology transfer service platform built by Zhihong that over the past seven years, Zhihong has focused on doing just one thing—Helping medical device products complete safety and efficacy validation under compliance, smoothly obtain market access qualifications, and accumulating service experience with over 200 companies and more than 400 innovative medical device projects.Upon the official completion of the Medical Device Inspection and Research Institute and the Manufacturing Center, a medical device technology transfer service system centered on compliance and risk control will be established for medical device products, covering the entire lifecycle of medical devices.

To Mr. Guo Lei, Board Secretary and Director of the Mass Innovation Business Division at Zhizhong Technology

The Medical Device Registration Inspection and Post-Market Supervision Summit also centered on the themes of “Compliance” and “Commercialization,” inviting industry experts and leaders to share insights from the perspectives of trends, regulations, and supervision.

Fan Xiaodong, Vice President of the China Association for Medical Device Industry (CAMDI), delivered a speech themed “New Opportunities for the Medical Device Industry in the New Era.”

Vice President of the China Association for Medical Devices Industry, Fan Xiaodong

Ren Haiping, Director of the Optoelectromechanical Division at the Institute for Medical Device Control, National Institutes for Food and Drug Control (NIFDC), shared insights on medical device testing and technical services with attendees.

Ren Haiping, Director of the Optics, Mechanics, and Electronics Division, Medical Device Inspection Institute, National Institutes for Food and Drug Control

Wang Aijun, Director of the Medical Device Division at the Center for Drug Evaluation and Inspection of the National Medical Products Administration, provided an on-site overview of unannounced inspections of medical devices conducted both domestically and internationally, as well as key priorities.

Wang Aijun, Director of the Medical Device Division, Center for Food and Drug Inspection and Verification, National Medical Products Administration

Jiang Haihong, Director of the Medical Device Regulation Program at Shanghai University of Medicine & Health Sciences, analyzed the prospects and legal risks of the Marketing Authorization Holder (MAH) system for medical devices.

Jiang Haihong, Director of the Medical Device Regulation Program at Shanghai University of Medicine and Health Sciences

Cai Yang, a medical device reviewer at the Hubei Provincial Food and Drug Administration, analyzes the key issues in the review of active medical devices.

Cai Yang, Medical Device Reviewer, Hubei Provincial Food and Drug Administration

Li Jing, Chief of the Business Section at the Hubei Provincial Institute for Medical Device Quality Supervision and Inspection, conducted an on-site analysis of the key issues in medical device supervisory sampling and testing.

Li Jing, Chief of the Business Section, Hubei Provincial Institute for Medical Device Quality Supervision and Inspection

With a lofty mission and heavy responsibilities, we unite as one to achieve excellence that stands out from the crowd, embodying the principle that great sound is often faintly heard. ZhiZhong Technology is deeply honored to host the inauguration ceremony for the ZhiZhong Medical Device Testing Institute and its CMO Platform at this Summit on Medical Device Registration Inspection and Post-Market Surveillance. We extend our sincere gratitude to the leaders, experts, and enterprises for their steadfast support. This is a season of harvest, where we rejoice in the sight of rippling waves of grain; it is also a milestone moment, as we aspire to soar into the vast sky. In the future, ZhiZhong will remain focused on a single mission: to build an ecosystem for medical device technology transfer services, ensuring that the translation of innovative medical device technologies is realized within the framework of regulatory compliance.