Successful Launch of the First Session of China Pharma Valley Academician and Expert Lecture Series (2021) under the 'Two Zones' Initiative

The COVID-19 pandemic in 2020 brought about a major shift in the global technological landscape, accelerating the arrival of an era characterized by the globalization of the digital and bioeconomies. Since the outbreak, there has been a surge in global demand for medical supplies, prompting countries worldwide to increase their investments in the medical device industry.

Medical devices are directly related to the life and health of the people. The CPC Central Committee and the State Council attach great importance to the quality, safety, and innovative development of medical devices. In recent years, with the rapid development of the medical device industry, the CPC Central Committee and the State Council have made a series of major decisions and deployments to reform the review and approval system for drugs and medical devices. On February 9, 2021, Premier Li Keqiang of the State Council signed State Council Decree No. 739, announcing that the revised Regulations on the Supervision and Administration of Medical Devices would come into effect on June 1, 2021.

In 2021, the European Union’s new Medical Device Regulation (MDR) will also replace the old Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD). The new MDR is an upgrade of existing regulations, upholding the same principles as the current directives and guidelines. However, to better protect patients, customers, and users, while providing a consistent and transparent industry approach, the new regulation introduces significant changes and stricter requirements in product development, data reporting, quality assurance, post-market surveillance processes, and clinical evidence. These changes have a substantial impact on all stakeholders in the medical device industry.

On this occasion, the CBPCA Alliance has provided strong support to its member unit—the Daxing Biomedical Industry Base of Zhongguancun National Independent Innovation Demonstration Zone—in hosting the “China Medicine Valley Academician and Expert Lecture Series” as part of the activities for the development of the “Two Zones.” The Alliance organized thematic events on “Registration Pathways and Strategies for Medical Devices in Domestic and International Markets” and roadshows for key projects.

Mr. Tian Dexiang, Party Secretary and Director of the Management Committee of the Daxing Biomedical Industry Base; Mr. Rui Guozhong, Secretary-General of the Biomedical Park Development Alliance under the China Association for Science and Technology Entrepreneurship; Dr. Fan Xiaodong, former Executive Deputy Director of the Center for Medical Device Evaluation (CMDE) under the National Medical Products Administration (NMPA); Mr. Bill, former Assistant Director for China at the FDA’s Office of Global Policy and Strategy and International Projects and Policy Analyst for Medical Devices; Mr. Li Qiang, Chief Scientist of Guangzhou Boji Medicine & Biotechnology Co., Ltd. and General Manager of Jiutai Pharmaceuticals & Medical Devices; along with more than 100 executives from medical device enterprises based in the park, Beijing, and across China, attended the conference. The online live stream attracted over 2,600 participants.

The conference was moderated by Mr. Rui Guozhong, Secretary-General of the Biomedical Park Development Alliance under the China Technology Entrepreneurship Association.

Rui Guozhong, Secretary-General of the Biomedical Park Development Alliance of the China Technology Entrepreneurship Association

Tian Dexiang, Secretary of the Working Committee and Director of the Administrative Committee of Daxing Biomedical Base

Tian Dexiang stated in his address:

The “Academician and Expert Lecture Series” is one of the branded initiatives established by the Daxing Biomedical Base to support enterprise development and serve high-level talent. The initiative aims to bring together academicians and experts from across China’s biomedical sector to the Base, fostering the growth of strategic scientific and technological talent within the park, helping park enterprises accelerate their expansion through science and innovation, and thereby driving rapid development in the pharmaceutical and health industries. He expressed hope that this event would enhance the capabilities of medical device companies in obtaining domestic and international registrations and market access, shorten the R&D-to-market cycle for medical devices, and support the development of China’s medical device industry.

Director Tian also introduced the construction and development of the biomedical base. Currently, the base is home to more than 4,800 enterprises, including over 160 high-tech companies, 18 listed companies, and 64 industrial enterprises above designated size. Last year, the total revenue of the entire park exceeded RMB 40 billion, with the output value of industrial enterprises above designated size reaching RMB 27.43 billion, a year-on-year increase of 35%. Both fiscal revenue and tax revenue grew by more than 30% year on year. An industrial pattern of “1+4+2” has taken shape.

At the conference, Dr. Fan Xiaodong, Chief Health Industry Advisor at DeHeng Law Offices and former Executive Deputy Director of the Center for Medical Device Evaluation under the National Medical Products Administration (NMPA), provided an in-depth analysis of the new landscape for innovative development of medical devices in China during the 14th Five-Year Plan period. Mr. Bill, who previously served as Assistant Director for China in the FDA’s Office of Global Policy and Strategy and as an International Projects and Policy Analyst for medical devices, presented via video on “FDA Compliance Requirements for Medical Device Regulation,” drawing on his more than 20 years of extensive experience. Dr. Zhou Yan, an expert from Guangzhou Jiutai Pharmaceutical and Medical Device, elaborated on various aspects of “Clinical Evaluation Reports for EU Medical Device Registration.” Finally, Mr. Li Qiang, Chief Scientific Officer (Medical Devices) at Guangzhou Boji Medicine Biotechnology Co., Ltd., delivered a speech on “New Opportunities for Domestic and Overseas Registration of Medical Devices.”

Fan Xiaodong, Chief Advisor to the Health Industry Practice at DeHeng Law Offices and Former Executive Deputy Director of the Center for Medical Device Evaluation (CMDE) under the National Medical Products Administration (NMPA)

Dr. Fan Xiaodong emphasized the future goal of achieving “high-quality development and high-quality living.” He conducted an in-depth analysis of the new landscape for innovative development of China’s medical device industry from four perspectives: the new development concepts of the 14th Five-Year Plan guided by the “Four Orientations,” the new model of scientific regulation for medical devices, the new development pattern characterized by integration and a return to fundamentals, and the emerging scenarios for home-based rehabilitation and age-appropriate products driven by population aging. His insights provide strategic direction for the innovative development of China’s medical device industry during the 14th Five-Year Plan period.

Mr. Bill Video Share

Mr. Bill, former Assistant Director for China in the FDA’s Office of Global Policy and Strategy and International Projects and Policy Analyst for Medical Devices, delivered a presentation titled “Compliance Requirements for U.S. FDA Regulation of Medical Devices.” Drawing on more than 20 years of extensive experience, he presented via video conference. He introduced FDA regulations for medical devices, with an emphasis on the types of 510(k) premarket submissions and key considerations at each step. He also summarized common issues to help applicants successfully submit 510(k) applications.

Dr. Zhou Yan, Expert in Pharmaceuticals and Medical Devices at Guangzhou Jiutai

Dr. Zhou Yan, an expert in pharmaceuticals and medical devices at Guangzhou Jiutai, provided a comprehensive overview of clinical evaluation reports for EU medical device registration. She detailed key aspects including the definition of clinical evaluation reports, an explanation of MEDDEV 2.7/1, core content requirements, the five stages of clinical evaluation, and common issues encountered in clinical evaluation reports.

Li Qiang, Chief Scientist of Guangzhou Boji Medicine Biotechnology Co., Ltd.

Mr. Li Qiang delivered a speech on “New Opportunities for Domestic and Overseas Registration of Medical Devices.”

At the meeting, five key medical device enterprises incubated by the park—Beijing Amate Medical Device Co., Ltd., Huake Jingzhun (Beijing) Medical Technology Co., Ltd., Jiansheng Biotechnology Co., Ltd., Beijing Huamai Taike Medical Device Co., Ltd., and Beijing Yaguo Technology Co., Ltd.—conducted project roadshows.

Liu Qing, Chairman of Beijing Amate Medical Device Co., Ltd.

Chairman Liu Qing Introduces the "New Generation of 3D-Printed Fully Biodegradable Vascular Stents"

Chen Xi, Director of Regulatory Affairs at Huake Jingzhun (Beijing) Medical Technology Co., Ltd.

Director Chen Xi Introduces the “Huake Precision Neurosurgical Navigation and Positioning System”

Jiansheng Biotechnology Co., Ltd. Kang Yanan

Director Kang Yanan introduced the “NMPA Innovative Gastric Cancer Diagnostic Reagent” project.

Liu Zhen, Operations Director of Beijing Huamai Taiko Medical Device Co., Ltd.

Director Liu Zhen Introduces “Innovative Domestically Produced Medical Device Product: Thoracic and Abdominal Aortic Stent-Graft System”

Jia Guangtao, Product Director of Beijing Yaguo Technology Co., Ltd.

Director Jia Guangtao Presents the “Innovative Devices for Respiratory Therapy and Airway Management” Project

Subsequently, in-depth discussions and interactions took place among the attending leaders, experts, and corporate representatives. With over 100 participants on-site, the atmosphere was highly vibrant. The event was live-streamed simultaneously to domestic and international audiences, attracting more than 2,600 online viewers.

With the official commencement of operations at Beijing Daxing International Airport and the formal approval of the Airport Economic Free Trade Zone, Daxing District has established a development pattern dominated by the pharmaceutical and health industry. This aligns with the district’s functional positioning as “Three Zones and One Gateway” and the implementation of the “Beijing Three-Year Action Plan for Medicine and Health.” The Daxing Biomedical Industry Base serves as the dedicated space for the development of the pharmaceutical and health industry within the Zhongguancun National Independent Innovation Demonstration Zone. It is recognized as a National New Industrialization Industry Demonstration Base and one of the first batches of Strategic Emerging Industry Clusters designated by the National Development and Reform Commission (NDRC), ranking among the top ten biomedical parks in China.The base covers a planned area of 13.4 square kilometers and currently hosts more than 4,000 enterprises. It has gathered a group of national-level authoritative institutions, including the National Institutes for Food and Drug Control (NIFDC), the China Institute of Veterinary Drug Control, and several institutes under the Chinese Academy of Medical Sciences—such as the Institute of Pathogen Biology, the Institute of Materia Medica, the Institute of Laboratory Animal Science, and the Institute of Biology—as well as the Tu Youyou Artemisinin Research Center of the China Academy of Chinese Medical Sciences. The base has also introduced a number of major domestic and international pharmaceutical projects, such as Sinovac Biotech, Fresenius Kabi, the time-honored Beijing Tongrentang, Peking Union Medical College Hospital’s century-old legacy projects, and the Medical Device Park of Zhongguancun Development Group. Consequently, it has formed a “1+4+2” industrial structure, with pharmaceutical R&D and testing as the leading sector; modern traditional Chinese medicine, innovative chemical drugs, medical devices, and biopharmaceuticals as the main sectors; and veterinary drugs and health supplements as the expanding sectors.

The successful hosting of the “Two Zones” Construction – China Medicine Valley Academician and Expert Lecture Series signifies the official launch of a new pattern for the Daxing Biomedical Industry Base in the new year, characterized by comprehensive opening-up, all-round cooperation, and full-scale development.