On March 26, 2021, China Association for Medical Devices Industry (CAMDI) held the 2021 Annual Policy Conference in Beijing.
Xu Jinghe, Deputy Commissioner of the National Medical Products Administration (NMPA), Jiang Deyuan, Director of Department of Medical Device Registration, Wang Zhexiong, Director of Department of Medical Device Regulation, Sun Lei, Director of Center for Medical Device Evaluation, and other government officials and experts attended the conference and delivered important speeches. CAMDI Chairman Zhao Yixin presided over the conference with nearly 500 member representatives attended.
Deputy Commissioner Xu Jinghe kicked off his speech with affirmation of the work CAMDI has achieved over the year, and expressed his full support to CAMDI's objective to promote self-discipline and development of the medical devices industry. He noted that in February 2017, General Office of the State Council issued the notice proposing to promote China's transformation from a large country to a strong country for its pharmaceutical industry in the 13th Five-Year Plan. In 2018, it further proposed to accelerate China's transformation from a large country to a strong country for its medical device manufacturing industry. He pointed out during the speech that China's medical device industry, in order to achieve this goal, must possess significant institutional advantages, excellent industrial clusters, outstanding innovation ability, sound regulatory system and substantial international influence. Standing at the present position and looking back at the history, the overall path-forward for the future development of China's medical device industry is to follow "the Four Most Stringent" requirements set by General Secretary Xi Jinping, and reflect the scientific law of drug and medical device regulation. He stressed that with protecting and promoting public health as the mission of medical device regulation and focusing on the five major themes of innovation, quality, efficiency, system and capability, the practical actions should be guided with three concepts of risk governance, responsibility governance and smart governance. The industry is required to stick to the scientific, legalized, international and modern development path, and to accelerate the modernization of regulatory system and capacity. In addition, it is required to reasonably facilitate China's medical science action plan, speed up the promotion of smart action plan for medical product regulation, and focus on both science and the rule of law. He hoped that all industries will be truly self-disciplined, pursue a healthy, scientific, innovative and excellent culture, and work together to speed up China's transformation from a large country to a strong country for its medical device manufacturing industry.
Director Jiang Deyuan particularly gave an introduction about the work completed in 2020 and the key arrangements in 2021 for the Department of Medical Device Registration. He indicated that the Department of Medical Device Registration in 2020 has carried out in-depth work to enhance pandemic prevention and control, continuously deepen the reform on review and approval, constantly consolidate foundation of laws and regulations, and improve the level of globalization on an ongoing basis. In the coming year, the Department of Medical Device Registration will fully implement the "Regulations on the Supervision and Administration of Medical Devices", safeguard the bottom line to ensure safety, and chase the high standard to promote development. The Department will also deepen the reform of medical device regulation, and fully promote the quality supervision of medical devices throughout the entire life cycle. In addition, it will comprehensively strengthen the establishment of regulatory system and capability, effectively ensure the safety and effectiveness of using medical device, and promote the high quality development of medical device industry, to celebrate the 100th anniversary of the founding of the Communist Party of China with outstanding achievement. The Department will focus on the following work: continuing to deepen the reform on the review and approval system, making every effort to formulate and revise the registration management laws and regulations, further consolidating the basis of registration management, strengthening the supervision and management of medical device registration, and comprehensively strengthening the capacity-building for the review and approval teams.
According to Director Wang Zhexiong's introduction, the Department of Medical Device Regulation in 2020, has rolled out various forms of on-scene inspection, special inspection, supervisory inspection, testing, and related investigations and handling of violation against regulations and laws to ensure the safety of pandemic prevention and control. The Department continued to promote multiple programs such as supervision and inspection of sterile implantable medical devices, the flight inspection and the "network cleaning" of medical devices. In 2021, the supervision and management of medical devices will fully implement the spirit of the National Supervision and Management Work Meeting for Medical Products, and make every effort to enhance the quality supervision of medical devices for epidemic prevention and control. The Department will carry out the hazard identification program for potential risks, strengthen the supervision for production, operation and use, and fully utilize various technical means such as adverse event monitoring and supervisory sampling, etc. In addition, it will effectively prevent and control the quality and safety risks, improve the quality and safety of medical devices, enhance the quality of medical device industry, and constantly promote the scientific, legalized, international and modern level of regulation. The Department will continue to carry out the regulation work in all aspects: making every effort to enhance the quality supervision of medical devices for pandemic prevention and control, implementing hazard identification program for potential risks, continuing to increase the production supervision and inspection, enhancing supervision and inspection of operation and use on an ongoing basis, keeping to increase the intensity of case investigation, giving full play to the role of supervision and random inspection, attaching great importance to adverse event monitoring, comprehensively rolling out risk consultation, constantly improving the establishment of laws and regulations and continuously increasing regulation capability.
Director Sun Lei said that 2020 was a year that the achievement related to the reform of medical device approval and review has experienced the test of the pandemic. At the beginning of the pandemic, the Center for Medical Device Evaluation pulled all efforts together and developed the world's first technical guidance of COVID-19 nucleic acid testing reagent, and approved the first COVID-19 nucleic acid testing reagent and the first COVID-19 antibody testing reagent in the world, setting new records in terms of time and quantity of approvals. The application review of medical devices was not affected by the pandemic. In 2020, the Center received 37,829 applications, a record high. Since March 2020, through various efforts, the implementation effect of the comprehensive reform measures over the years has been presented, and the overdue rate of review has dropped to below 3%. In addition, the Center for Medical Device Evaluation is also in the process of deepening the reform on review and approval system and scientific research work, promoting the construction of sub-centers, and implementing the concept of "delegating power and optimizing service" and providing smooth communication. In the future, the Center for Medical Device Evaluation will "be people-oriented, protect and promote public health", always maintain excellence and give full play to its potential. It targets to build a world-class evaluation organization and first-class evaluation team through 5-10 years' efforts. Focus should be put on aspects such as high-end medical equipment evaluation system, focus forward of review and approval, and joint review and evaluation, in a bid to consolidate the reform achievement about the review and approval system; By further stimulating enterprise to drive innovation, the Center will help with boosting the key and core technical breakthrough. Efforts will be given to improve evaluation of domestic independent R&D products, promote the informational level of medical device registration review and evaluation, and enhance the industrial innovation and development.
Dr. Tao Libo, Research Fellow/Assistant Director of the Center for Health Policy and Technology Evaluation, Peking University Health Science Center, analyzed the economic logic behind China's volume-based medicine purchasing practice. In his opinion, the centralized medicine procurement practice in China has entered a new phase, starting from the "4+7" centralized medicine procurement led by the medical insurance bureau. Its internal mechanism is to change the operation mode on supply side of the medicine industry and reduce costs, thus to form a new supply curve and the possibility of a new balance between supply and demand. The price mechanism, quantity mechanism, management method, etc., of the centralized medicine procurement all have complex contents, forming a complete set of system. At present, the achievement is remarkable and has been recognized by multiple stakeholders. The success of the centralized medicine procurement inspired the authorities to push the centralized procurement of medical consumables to the front. However, the problems are more complex. All walks of life, including industry community and medical institutions, need to understand the direction of the policy and the efforts of the authorities, in order to jointly promote establishment and development of the new business model for the medical industry in China.
Yu Xinhua, Director of the Center for Medical Device Standards Management, the National Medical Products Administration (NMPA), particularly introduced the work concepts and key points of the Center in 2021: implement the "most rigorous standards", strengthen refined management of formulation and revision process, and promote the implementation of important standards. He pointed out that the Center will further encourage all relevant parties to participate in the formulation and revision of standards, and motivate enterprises to actively participate in the formulation and revision of recommended standards and take the lead in drafting recommended standards. The Center will explore the new model of government-led and public welfare promotion + enterprise active participation in promoting standards. In addition, it will explore the introduction of competitive working mechanism in formulation and revision of standards.
Chen Yan, Director of Center for Food and Drug Inspection (CFDI) of NMPA, disclosed that in 2020, CFDI sent out 76 inspection teams and 334 inspectors to conduct flight inspections for 89 medical device manufacturers. There were 687 non-conformity items identified, mainly in production management, plant and facilities, equipment and quality control, accounting for 58.8% in total. In terms of countermeasures, she suggested that enterprises further enhance the awareness of corporate responsibility, quality management and risk management. Enterprises should also strengthen training, constantly improve the capability and level of quality management personnel, and enhance the ability of risk identification and control. In addition, enterprises should implement the accountability system, strengthen self-examination, and constantly improve the quality management system
Zhao Yan, senior engineer of the Center for Drug Reevaluation, NMPA, gave a presentation titled "Current Situation of Adverse Medical Device Event Monitoring and Key Work in 2021". She indicated that in 2020, the average number of medical device adverse event reports per million people in China was 402, representing an increase of 35.35% over the previous year. In 2021, the Center for Drug Reevaluation will promote implementation of the corporate responsibility system for supervision and monitoring and carry out special inspection for adverse event monitoring. It will also continue to strengthen risk management and control, and actively take risk mitigation measures. In addition, the Center will carry out extensive hazard identification to eliminate potential risks. For the "14th Five-Year Plan" period, it will formulate reasonable key monitoring work plan and product selection plan. In addition, the Center will strengthen the post-marketing supervision of real-world data services, and carry out research on the alert system of medical devices.
Xu Feng from the Medical Engineering Department of Peking University Third Hospital, introduced the beneficial exploration of Peking University Third Hospital in management and control of medical consumables and indicator assessment. He noted that with the change of medical insurance payment policy and regulation mode, the pilot program of the original Beijing version for DRG will be ceased in the first half of 2021, and the national version of CHS-DRG Beijing version will be simulated and run in the second half of 2021. The medical insurance inspection will be stricter, and therefore it is necessary to abandon the rough management mode, focus on refined management and find out new growth points.
Song Qisen, Deputy Director of Medical Products Department, Consumer Goods Division, the Ministry of Industry and Information Technology of the P.R.C., delivered a keynote speech titled Economic Operation of the Medical Industry and Related Industrial Policies. As it says, generally speaking, the medical industry in 2020 has been running smoothly and made steady contribution to economic development. The added value of the enterprises above designated size in the medical industry increased by 7.8% year on year, 6 percentage points higher than the overall growth of the national industry, ranking in the forefront of the whole industries. The main business income of enterprises above designated size reached RMB 2,831.22 billion, a year-on-year increase of 6.0%, and the growth rate decreased by 1.9 percentage points compared with the same period of last year. At the beginning of "the 13th Five-Year Plan", the Ministry of Industry and Information Technology proposed five major projects including the construction project of national manufacturing innovation center, and ten key fields, such as bio-medicine and high-performance medical devices, etc. In 2020, 15 projects have been completed with the objectives achieved. Intelligent manufacturing pilot demonstration projects and green manufacturing system integration projects have also supported many enterprises, and many pilot demonstration enterprises have been rated as benchmark enterprises in the industry "The 14th Five-Year Plan" for the development of the medical industry has basically taken shape and will focus on: first, accelerating industrial innovation; second, giving full play to the advantages of the entire industry chain; and third, developing medicine supply and emergency security system.
CAMDI Chairman Zhao Yixin remarked at the conference that 2020 was a year that the entire world has experienced an unexpectedly huge change in a century. During the pandemic, CAMDI has fully cooperated with the pandemic prevention and control, kept close contact with many government functional departments, and closely work together with relevant parties to give full play to the advantages of the platform and coordinate the emergency material supply guarantee work. CAMDI has improved its understanding about medical protection, manufacturing capacity status and production increase situations for diagnosis and treatment products, and industry chain and supply chain research. In addition, CAMDI has collected the directory and contact information of manufacturers involved in pandemic prevention and diagnosis and treatment products, organized enterprises to directly connect with relevant ministries and commissions, and actively exemplified the platform role of CAMDI. As a bridge between government authorities and enterprises, CAMDI will actively make improvement in publicizing and implementing new regulations and other important policies in 2021 to contribute more to the development of the industry.
Xu Jinghe, Deputy Commissioner of the National Medical Products Administration (NMPA), Jiang Deyuan, Director of Department of Medical Device Registration, Wang Zhexiong, Director of Department of Medical Device Regulation, Sun Lei, Director of Center for Medical Device Evaluation, and other government officials and experts attended the conference and delivered important speeches. CAMDI Chairman Zhao Yixin presided over the conference with nearly 500 member representatives attended.
Deputy Commissioner Xu Jinghe kicked off his speech with affirmation of the work CAMDI has achieved over the year, and expressed his full support to CAMDI's objective to promote self-discipline and development of the medical devices industry. He noted that in February 2017, General Office of the State Council issued the notice proposing to promote China's transformation from a large country to a strong country for its pharmaceutical industry in the 13th Five-Year Plan. In 2018, it further proposed to accelerate China's transformation from a large country to a strong country for its medical device manufacturing industry. He pointed out during the speech that China's medical device industry, in order to achieve this goal, must possess significant institutional advantages, excellent industrial clusters, outstanding innovation ability, sound regulatory system and substantial international influence. Standing at the present position and looking back at the history, the overall path-forward for the future development of China's medical device industry is to follow "the Four Most Stringent" requirements set by General Secretary Xi Jinping, and reflect the scientific law of drug and medical device regulation. He stressed that with protecting and promoting public health as the mission of medical device regulation and focusing on the five major themes of innovation, quality, efficiency, system and capability, the practical actions should be guided with three concepts of risk governance, responsibility governance and smart governance. The industry is required to stick to the scientific, legalized, international and modern development path, and to accelerate the modernization of regulatory system and capacity. In addition, it is required to reasonably facilitate China's medical science action plan, speed up the promotion of smart action plan for medical product regulation, and focus on both science and the rule of law. He hoped that all industries will be truly self-disciplined, pursue a healthy, scientific, innovative and excellent culture, and work together to speed up China's transformation from a large country to a strong country for its medical device manufacturing industry.
Director Jiang Deyuan particularly gave an introduction about the work completed in 2020 and the key arrangements in 2021 for the Department of Medical Device Registration. He indicated that the Department of Medical Device Registration in 2020 has carried out in-depth work to enhance pandemic prevention and control, continuously deepen the reform on review and approval, constantly consolidate foundation of laws and regulations, and improve the level of globalization on an ongoing basis. In the coming year, the Department of Medical Device Registration will fully implement the "Regulations on the Supervision and Administration of Medical Devices", safeguard the bottom line to ensure safety, and chase the high standard to promote development. The Department will also deepen the reform of medical device regulation, and fully promote the quality supervision of medical devices throughout the entire life cycle. In addition, it will comprehensively strengthen the establishment of regulatory system and capability, effectively ensure the safety and effectiveness of using medical device, and promote the high quality development of medical device industry, to celebrate the 100th anniversary of the founding of the Communist Party of China with outstanding achievement. The Department will focus on the following work: continuing to deepen the reform on the review and approval system, making every effort to formulate and revise the registration management laws and regulations, further consolidating the basis of registration management, strengthening the supervision and management of medical device registration, and comprehensively strengthening the capacity-building for the review and approval teams.
According to Director Wang Zhexiong's introduction, the Department of Medical Device Regulation in 2020, has rolled out various forms of on-scene inspection, special inspection, supervisory inspection, testing, and related investigations and handling of violation against regulations and laws to ensure the safety of pandemic prevention and control. The Department continued to promote multiple programs such as supervision and inspection of sterile implantable medical devices, the flight inspection and the "network cleaning" of medical devices. In 2021, the supervision and management of medical devices will fully implement the spirit of the National Supervision and Management Work Meeting for Medical Products, and make every effort to enhance the quality supervision of medical devices for epidemic prevention and control. The Department will carry out the hazard identification program for potential risks, strengthen the supervision for production, operation and use, and fully utilize various technical means such as adverse event monitoring and supervisory sampling, etc. In addition, it will effectively prevent and control the quality and safety risks, improve the quality and safety of medical devices, enhance the quality of medical device industry, and constantly promote the scientific, legalized, international and modern level of regulation. The Department will continue to carry out the regulation work in all aspects: making every effort to enhance the quality supervision of medical devices for pandemic prevention and control, implementing hazard identification program for potential risks, continuing to increase the production supervision and inspection, enhancing supervision and inspection of operation and use on an ongoing basis, keeping to increase the intensity of case investigation, giving full play to the role of supervision and random inspection, attaching great importance to adverse event monitoring, comprehensively rolling out risk consultation, constantly improving the establishment of laws and regulations and continuously increasing regulation capability.
Director Sun Lei said that 2020 was a year that the achievement related to the reform of medical device approval and review has experienced the test of the pandemic. At the beginning of the pandemic, the Center for Medical Device Evaluation pulled all efforts together and developed the world's first technical guidance of COVID-19 nucleic acid testing reagent, and approved the first COVID-19 nucleic acid testing reagent and the first COVID-19 antibody testing reagent in the world, setting new records in terms of time and quantity of approvals. The application review of medical devices was not affected by the pandemic. In 2020, the Center received 37,829 applications, a record high. Since March 2020, through various efforts, the implementation effect of the comprehensive reform measures over the years has been presented, and the overdue rate of review has dropped to below 3%. In addition, the Center for Medical Device Evaluation is also in the process of deepening the reform on review and approval system and scientific research work, promoting the construction of sub-centers, and implementing the concept of "delegating power and optimizing service" and providing smooth communication. In the future, the Center for Medical Device Evaluation will "be people-oriented, protect and promote public health", always maintain excellence and give full play to its potential. It targets to build a world-class evaluation organization and first-class evaluation team through 5-10 years' efforts. Focus should be put on aspects such as high-end medical equipment evaluation system, focus forward of review and approval, and joint review and evaluation, in a bid to consolidate the reform achievement about the review and approval system; By further stimulating enterprise to drive innovation, the Center will help with boosting the key and core technical breakthrough. Efforts will be given to improve evaluation of domestic independent R&D products, promote the informational level of medical device registration review and evaluation, and enhance the industrial innovation and development.
Dr. Tao Libo, Research Fellow/Assistant Director of the Center for Health Policy and Technology Evaluation, Peking University Health Science Center, analyzed the economic logic behind China's volume-based medicine purchasing practice. In his opinion, the centralized medicine procurement practice in China has entered a new phase, starting from the "4+7" centralized medicine procurement led by the medical insurance bureau. Its internal mechanism is to change the operation mode on supply side of the medicine industry and reduce costs, thus to form a new supply curve and the possibility of a new balance between supply and demand. The price mechanism, quantity mechanism, management method, etc., of the centralized medicine procurement all have complex contents, forming a complete set of system. At present, the achievement is remarkable and has been recognized by multiple stakeholders. The success of the centralized medicine procurement inspired the authorities to push the centralized procurement of medical consumables to the front. However, the problems are more complex. All walks of life, including industry community and medical institutions, need to understand the direction of the policy and the efforts of the authorities, in order to jointly promote establishment and development of the new business model for the medical industry in China.
Yu Xinhua, Director of the Center for Medical Device Standards Management, the National Medical Products Administration (NMPA), particularly introduced the work concepts and key points of the Center in 2021: implement the "most rigorous standards", strengthen refined management of formulation and revision process, and promote the implementation of important standards. He pointed out that the Center will further encourage all relevant parties to participate in the formulation and revision of standards, and motivate enterprises to actively participate in the formulation and revision of recommended standards and take the lead in drafting recommended standards. The Center will explore the new model of government-led and public welfare promotion + enterprise active participation in promoting standards. In addition, it will explore the introduction of competitive working mechanism in formulation and revision of standards.
Chen Yan, Director of Center for Food and Drug Inspection (CFDI) of NMPA, disclosed that in 2020, CFDI sent out 76 inspection teams and 334 inspectors to conduct flight inspections for 89 medical device manufacturers. There were 687 non-conformity items identified, mainly in production management, plant and facilities, equipment and quality control, accounting for 58.8% in total. In terms of countermeasures, she suggested that enterprises further enhance the awareness of corporate responsibility, quality management and risk management. Enterprises should also strengthen training, constantly improve the capability and level of quality management personnel, and enhance the ability of risk identification and control. In addition, enterprises should implement the accountability system, strengthen self-examination, and constantly improve the quality management system
Zhao Yan, senior engineer of the Center for Drug Reevaluation, NMPA, gave a presentation titled "Current Situation of Adverse Medical Device Event Monitoring and Key Work in 2021". She indicated that in 2020, the average number of medical device adverse event reports per million people in China was 402, representing an increase of 35.35% over the previous year. In 2021, the Center for Drug Reevaluation will promote implementation of the corporate responsibility system for supervision and monitoring and carry out special inspection for adverse event monitoring. It will also continue to strengthen risk management and control, and actively take risk mitigation measures. In addition, the Center will carry out extensive hazard identification to eliminate potential risks. For the "14th Five-Year Plan" period, it will formulate reasonable key monitoring work plan and product selection plan. In addition, the Center will strengthen the post-marketing supervision of real-world data services, and carry out research on the alert system of medical devices.
Xu Feng from the Medical Engineering Department of Peking University Third Hospital, introduced the beneficial exploration of Peking University Third Hospital in management and control of medical consumables and indicator assessment. He noted that with the change of medical insurance payment policy and regulation mode, the pilot program of the original Beijing version for DRG will be ceased in the first half of 2021, and the national version of CHS-DRG Beijing version will be simulated and run in the second half of 2021. The medical insurance inspection will be stricter, and therefore it is necessary to abandon the rough management mode, focus on refined management and find out new growth points.
Song Qisen, Deputy Director of Medical Products Department, Consumer Goods Division, the Ministry of Industry and Information Technology of the P.R.C., delivered a keynote speech titled Economic Operation of the Medical Industry and Related Industrial Policies. As it says, generally speaking, the medical industry in 2020 has been running smoothly and made steady contribution to economic development. The added value of the enterprises above designated size in the medical industry increased by 7.8% year on year, 6 percentage points higher than the overall growth of the national industry, ranking in the forefront of the whole industries. The main business income of enterprises above designated size reached RMB 2,831.22 billion, a year-on-year increase of 6.0%, and the growth rate decreased by 1.9 percentage points compared with the same period of last year. At the beginning of "the 13th Five-Year Plan", the Ministry of Industry and Information Technology proposed five major projects including the construction project of national manufacturing innovation center, and ten key fields, such as bio-medicine and high-performance medical devices, etc. In 2020, 15 projects have been completed with the objectives achieved. Intelligent manufacturing pilot demonstration projects and green manufacturing system integration projects have also supported many enterprises, and many pilot demonstration enterprises have been rated as benchmark enterprises in the industry "The 14th Five-Year Plan" for the development of the medical industry has basically taken shape and will focus on: first, accelerating industrial innovation; second, giving full play to the advantages of the entire industry chain; and third, developing medicine supply and emergency security system.
CAMDI Chairman Zhao Yixin remarked at the conference that 2020 was a year that the entire world has experienced an unexpectedly huge change in a century. During the pandemic, CAMDI has fully cooperated with the pandemic prevention and control, kept close contact with many government functional departments, and closely work together with relevant parties to give full play to the advantages of the platform and coordinate the emergency material supply guarantee work. CAMDI has improved its understanding about medical protection, manufacturing capacity status and production increase situations for diagnosis and treatment products, and industry chain and supply chain research. In addition, CAMDI has collected the directory and contact information of manufacturers involved in pandemic prevention and diagnosis and treatment products, organized enterprises to directly connect with relevant ministries and commissions, and actively exemplified the platform role of CAMDI. As a bridge between government authorities and enterprises, CAMDI will actively make improvement in publicizing and implementing new regulations and other important policies in 2021 to contribute more to the development of the industry.
This event was greatly supported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., Mid-Link Group Company Limited, BD Medical Devices (Shanghai) Co., Ltd., Tianjin Economic and Technological Development Zone-TEDA, Medical Strong (Beijing) Technology Development Co., Ltd., and Beidaihe New District of Qinhuangdao.
