The 7th China Medical Devices Design and Entrepreneurship Competition (2024) and Global Device Week (GDW) successfully concluded in Shaoxing on November 1. As important components of the GDW this year, five seminars - Academic Exchange Meeting on Safety Evaluation of Innovative Medical Devices, Seminar on Innovation in Inspection and Testing Services, Seminar on Accelerated Registration Review Services, Seminar on New Future of Aesthetic Medicine, and First China (Shaoxing) Medical Device Innovation and Entrepreneurship Conference - were in the spotlight, with each session packed with participants and receiving high praise from innovative enterprises across the country.
These sessions brought together professional reviewers from local medical device review centers, experts from provincial and municipal institutes of medical device testing, renowned domestic and international scholars and experts, industry leaders, and government officials, with Academicians Teng Gaojun and Gu Ning from the Chinese Academy of Sciences specially invited to deliver keynote speeches, in a bid to build a high-level professional exchange platform for participants and jointly promote the healthcare industry’s development.
Medical device enterprises often need answers to a series of key questions in their development: How to select regions with more efficient approval processes? Which enterprises and products can meet the criteria for fast review? Which regions have better inspection and testing systems to provide strong technical support and quality assurance for medical device R&D and production? Which types of medical devices are subject to strict safety evaluations? In particular, what are the technical review requirements and product standards for plastic surgery medical devices?
With these questions, let us review the five seminars this year to explore their valuable information and guidance.
Seminar on Innovation in Inspection and Testing Services
The seminar focused on the core issue of “innovation in inspection and testing services.” Guest speakers included Zhang Yun from the Tianjin Medical Devices Quality Supervision and Testing Center, Dr. Yan Wentao from the Shanghai Institute of Medical Device Testing, Xu Zhongmin from the Zhejiang Institute of Medical Device Testing, Xia Peng from the Jiangsu Institute of Medical Device Testing, and Xu Pinghua from the Zhejiang Institute of Medical Device Testing, who conducted in-depth discussions on how to balance innovation and safety.
They stated that in the wave of medical device innovation, strengthening risk management and type inspection are crucial means to ensure product safety and effectiveness, and that fast inspection channels should be established for high-end medical devices such as cardiovascular implants, to accelerate the application of sci-tech achievements. They shared the key role of animal experiments in evaluating medical device safety, emphasizing the indispensability of the experimental results for products’ pre-marketing risk assessment. Furthermore, they elaborated from a user experience perspective on methods for enhancing medical device safety and user-friendliness through usability testing. They discussed the importance of preventing the release of hazardous substances from medical devices and put forward related preventive measures.
The experts agreed that it is important to establish an efficient cooperation platform in the context of an increasingly complex regulatory environment and technical challenges. Wang Peng from the Tianjin Medical Devices Quality Supervision and Testing Center suggested strengthening communication and cooperation between institutions to jointly address potential issues in the future and ensure the medical device industry’s healthy development.
Seminar on Accelerated Registration Review Services
The Seminar on Accelerated Registration Review Services brought together guest speakers including Section Chief Zheng Chao from the Zhejiang Center for Medical Device Evaluation, Deputy Section Chief Wang Wenjuan from the Evaluation Center of Jiangsu Medical Products Administration, Deputy Director Cui Tao from the Tianjin Medical Device Review and Inspection Center, Senior Reviewer Zhang Ying from the Shanghai Medical Device and Cosmetic Evaluation and Verification Center, Executive Director Ms. Wu Shan from RAMED (Beijing) Medical Technology Co., Ltd. (a subsidiary of Pharmaron), who shared detailed views on measures to optimize medical device registration review, classification rules for medical device registration review, common issues in technical review, local service initiatives, and strategies for fast certification. Section Chief Zheng Chao from the Zhejiang Center for Medical Device Evaluation presented a series of measures taken by Zhejiang to improve efficiency in medical device registration review and approval, including shortening review time, unifying technical standards, and improving digital service levels, and emphasized the province’s comprehensive support for innovative projects.
The experts’ sharing of insights and practical experience not only provided participants with valuable guidance and inspiration but also injected new vitality into the innovative development of China’s medical device industry. The seminar not only served as a profound reflection and optimization of the existing review system but also represented an active exploration of the future development directions of the medical device industry. As the policy environment continues to improve and technological means continue to be innovated, China’s medical device industry will see more brilliant development prospects and contribute more Chinese wisdom and solutions to the global health cause.
Academic Exchange Meeting on Safety Evaluation of Innovative Medical Devices
At the Academic Exchange Meeting on Safety Evaluation of Innovative Medical Devices, top experts from medical devices, biomaterials, clinical medicine, and other fields jointly discussed the latest developments and future directions in medical device safety evaluation. Through in-depth exchange and cooperation, the meeting aimed to promote the innovative development of the medical device industry, improve product quality and safety, and provide strong support for the industry’s healthy and sustainable development.
At the meeting, experts first outlined the new requirements of the latest medical device registration policy for biomaterial evaluation, emphasized the importance of biomaterial safety and effectiveness, and showcased efficient evaluation methods. Then, experts discussed international regulatory strategies and development trends for biomaterial medical products, mentioned regulatory challenges brought by technological progress, and gave suggestions for responses. They also focused on chemical characterization techniques for new medical devices and demonstrated their importance in risk identification. Furthermore, they shared successful cases of medical device innovation and transformation and emphasized the necessity of aligning technology with market demands. Finally, experts discussed in depth the biological evaluation of tissue repair medical devices, presented related testing methods and standards, and highlighted the complexity and importance of safety evaluation for such products.
This meeting not only enhanced information sharing among professionals but also provided important theoretical basis and technical support for the safety evaluation of medical devices, with far-reaching significance for promoting the industry’s healthy development. Active interactions during the meeting laid a good foundation for future cooperation and innovation.
Training Session on Regulatory Rules and Technological Innovations in Plastic Surgery Medical Devices
At the Seminar on New Future of Aesthetic Medicine, experts conducted thorough discussions on core issues such as the technical review, clinical evaluation, quality evaluation, and standardization of new facial filler products and the physicochemical and biological evaluations of hyaluronic acid gels. The seminar emphasized key points and standards in technical review, provided guidance for product applications, explained in detail the entire process of facial fillers from raw material selection and production processes to quality control, and underscored the importance of standardization. Regarding widely-used hyaluronic acid gels, experts analyzed their physicochemical properties and biological characteristics to provide scientific bases.
Moreover, the China Association for Medical Devices Industry launched a Weibo-based promotion and co-building plan designed to support the brand building of industry enterprises and doctors through social media. The seminar also interpreted new trends in regulations for medical cosmetology devices in the United States and the European Union, to help participants understand the latest international policies. Regarding UDI implementation, experts discussed its impact on the circulation of medical devices in China, including management mechanism optimization and circulation efficiency improvement.
Finally, the seminar focused on the scientificity and safety of injectable hyaluronic acid gels in aesthetic medicine and shared methods and precautions for safe use. According to participants, this seminar not only enhanced their professional skills but also promoted exchange and cooperation within the industry and strongly supported the development of the plastic surgery medical device sector.
First China (Shaoxing) Medical Device Innovation and Entrepreneurship Conference
The First China (Shaoxing) Medical Device Innovation and Entrepreneurship Conference was grandly held on the last day of the GDW. The conference attracted over 500 industry elites, including several academicians from the Chinese Academy of Sciences, as an important component of the 7th China Medical Devices Design and Entrepreneurship Competition (2024) and Global Device Week. The conference aimed to promote innovation and development in the medical device industry by holding activities such as high-end forums, professional competitions, and industry matchmaking activities. Academicians Teng Gaojun and Gu Ning delivered keynote speeches on medical device innovation technology and development trends at the conference. Additionally, several important activities were held, such as an award ceremony and innovation service center unveiling, to show the rapid development and enormous potential of Shaoxing and Zhejiang Province in the medical device industry.
The successful holding of the above sessions manifested the vitality and innovation capability of China’s medical device industry and offered global peers an opportunity to understand China’s medical device market. Looking ahead, as the policy environment continues to improve and technology continues to progress, China’s medical device industry will see more brilliant development prospects. Let us look forward to a greater role of China’s medical device industry on the international stage and the industry’s more contributions to human health in the near future.
Source: Innomd.org
These sessions brought together professional reviewers from local medical device review centers, experts from provincial and municipal institutes of medical device testing, renowned domestic and international scholars and experts, industry leaders, and government officials, with Academicians Teng Gaojun and Gu Ning from the Chinese Academy of Sciences specially invited to deliver keynote speeches, in a bid to build a high-level professional exchange platform for participants and jointly promote the healthcare industry’s development.
Medical device enterprises often need answers to a series of key questions in their development: How to select regions with more efficient approval processes? Which enterprises and products can meet the criteria for fast review? Which regions have better inspection and testing systems to provide strong technical support and quality assurance for medical device R&D and production? Which types of medical devices are subject to strict safety evaluations? In particular, what are the technical review requirements and product standards for plastic surgery medical devices?
With these questions, let us review the five seminars this year to explore their valuable information and guidance.
Seminar on Innovation in Inspection and Testing Services
The seminar focused on the core issue of “innovation in inspection and testing services.” Guest speakers included Zhang Yun from the Tianjin Medical Devices Quality Supervision and Testing Center, Dr. Yan Wentao from the Shanghai Institute of Medical Device Testing, Xu Zhongmin from the Zhejiang Institute of Medical Device Testing, Xia Peng from the Jiangsu Institute of Medical Device Testing, and Xu Pinghua from the Zhejiang Institute of Medical Device Testing, who conducted in-depth discussions on how to balance innovation and safety.
They stated that in the wave of medical device innovation, strengthening risk management and type inspection are crucial means to ensure product safety and effectiveness, and that fast inspection channels should be established for high-end medical devices such as cardiovascular implants, to accelerate the application of sci-tech achievements. They shared the key role of animal experiments in evaluating medical device safety, emphasizing the indispensability of the experimental results for products’ pre-marketing risk assessment. Furthermore, they elaborated from a user experience perspective on methods for enhancing medical device safety and user-friendliness through usability testing. They discussed the importance of preventing the release of hazardous substances from medical devices and put forward related preventive measures.
The experts agreed that it is important to establish an efficient cooperation platform in the context of an increasingly complex regulatory environment and technical challenges. Wang Peng from the Tianjin Medical Devices Quality Supervision and Testing Center suggested strengthening communication and cooperation between institutions to jointly address potential issues in the future and ensure the medical device industry’s healthy development.
Seminar on Accelerated Registration Review Services
The Seminar on Accelerated Registration Review Services brought together guest speakers including Section Chief Zheng Chao from the Zhejiang Center for Medical Device Evaluation, Deputy Section Chief Wang Wenjuan from the Evaluation Center of Jiangsu Medical Products Administration, Deputy Director Cui Tao from the Tianjin Medical Device Review and Inspection Center, Senior Reviewer Zhang Ying from the Shanghai Medical Device and Cosmetic Evaluation and Verification Center, Executive Director Ms. Wu Shan from RAMED (Beijing) Medical Technology Co., Ltd. (a subsidiary of Pharmaron), who shared detailed views on measures to optimize medical device registration review, classification rules for medical device registration review, common issues in technical review, local service initiatives, and strategies for fast certification. Section Chief Zheng Chao from the Zhejiang Center for Medical Device Evaluation presented a series of measures taken by Zhejiang to improve efficiency in medical device registration review and approval, including shortening review time, unifying technical standards, and improving digital service levels, and emphasized the province’s comprehensive support for innovative projects.
The experts’ sharing of insights and practical experience not only provided participants with valuable guidance and inspiration but also injected new vitality into the innovative development of China’s medical device industry. The seminar not only served as a profound reflection and optimization of the existing review system but also represented an active exploration of the future development directions of the medical device industry. As the policy environment continues to improve and technological means continue to be innovated, China’s medical device industry will see more brilliant development prospects and contribute more Chinese wisdom and solutions to the global health cause.
Academic Exchange Meeting on Safety Evaluation of Innovative Medical Devices
At the Academic Exchange Meeting on Safety Evaluation of Innovative Medical Devices, top experts from medical devices, biomaterials, clinical medicine, and other fields jointly discussed the latest developments and future directions in medical device safety evaluation. Through in-depth exchange and cooperation, the meeting aimed to promote the innovative development of the medical device industry, improve product quality and safety, and provide strong support for the industry’s healthy and sustainable development.
At the meeting, experts first outlined the new requirements of the latest medical device registration policy for biomaterial evaluation, emphasized the importance of biomaterial safety and effectiveness, and showcased efficient evaluation methods. Then, experts discussed international regulatory strategies and development trends for biomaterial medical products, mentioned regulatory challenges brought by technological progress, and gave suggestions for responses. They also focused on chemical characterization techniques for new medical devices and demonstrated their importance in risk identification. Furthermore, they shared successful cases of medical device innovation and transformation and emphasized the necessity of aligning technology with market demands. Finally, experts discussed in depth the biological evaluation of tissue repair medical devices, presented related testing methods and standards, and highlighted the complexity and importance of safety evaluation for such products.
This meeting not only enhanced information sharing among professionals but also provided important theoretical basis and technical support for the safety evaluation of medical devices, with far-reaching significance for promoting the industry’s healthy development. Active interactions during the meeting laid a good foundation for future cooperation and innovation.
Training Session on Regulatory Rules and Technological Innovations in Plastic Surgery Medical Devices
At the Seminar on New Future of Aesthetic Medicine, experts conducted thorough discussions on core issues such as the technical review, clinical evaluation, quality evaluation, and standardization of new facial filler products and the physicochemical and biological evaluations of hyaluronic acid gels. The seminar emphasized key points and standards in technical review, provided guidance for product applications, explained in detail the entire process of facial fillers from raw material selection and production processes to quality control, and underscored the importance of standardization. Regarding widely-used hyaluronic acid gels, experts analyzed their physicochemical properties and biological characteristics to provide scientific bases.
Moreover, the China Association for Medical Devices Industry launched a Weibo-based promotion and co-building plan designed to support the brand building of industry enterprises and doctors through social media. The seminar also interpreted new trends in regulations for medical cosmetology devices in the United States and the European Union, to help participants understand the latest international policies. Regarding UDI implementation, experts discussed its impact on the circulation of medical devices in China, including management mechanism optimization and circulation efficiency improvement.
Finally, the seminar focused on the scientificity and safety of injectable hyaluronic acid gels in aesthetic medicine and shared methods and precautions for safe use. According to participants, this seminar not only enhanced their professional skills but also promoted exchange and cooperation within the industry and strongly supported the development of the plastic surgery medical device sector.
First China (Shaoxing) Medical Device Innovation and Entrepreneurship Conference
The First China (Shaoxing) Medical Device Innovation and Entrepreneurship Conference was grandly held on the last day of the GDW. The conference attracted over 500 industry elites, including several academicians from the Chinese Academy of Sciences, as an important component of the 7th China Medical Devices Design and Entrepreneurship Competition (2024) and Global Device Week. The conference aimed to promote innovation and development in the medical device industry by holding activities such as high-end forums, professional competitions, and industry matchmaking activities. Academicians Teng Gaojun and Gu Ning delivered keynote speeches on medical device innovation technology and development trends at the conference. Additionally, several important activities were held, such as an award ceremony and innovation service center unveiling, to show the rapid development and enormous potential of Shaoxing and Zhejiang Province in the medical device industry.
The successful holding of the above sessions manifested the vitality and innovation capability of China’s medical device industry and offered global peers an opportunity to understand China’s medical device market. Looking ahead, as the policy environment continues to improve and technology continues to progress, China’s medical device industry will see more brilliant development prospects. Let us look forward to a greater role of China’s medical device industry on the international stage and the industry’s more contributions to human health in the near future.
Source: Innomd.org