The "Medical Devices MAH System Frontier Issues" strategic seminar ended successfully

On August 1, 2019, the State Food and Drug Administration issued the "Notice on Expanding the Pilot Work of the Medical Device Registrant System." The Strategic Seminar on "Foreign Issues of Medical Device Registrant System" sponsored by the District Management Committee, sponsored by the Medical Device Innovation Society and co-organized by the Jiangsu Medical Device Technology Industrial Park was successfully concluded at the Qingshan Conference Center in Suzhou High-tech Zone on October 9, 2019.

The theme of this strategic seminar is "Focusing on System Innovation and Leading the High-Quality Development of the Medical Device Industry". Relevant leaders of Suzhou City and High-tech Zone, Jiangsu Drug Administration, leaders of relevant drug regulatory departments in some urban areas of Jiangsu Province, and medical devices More than 300 people including innovative society members, well-known experts and scholars from the medical device field, CDMO representative companies, R & D institutions, investment institutions, production institutions and other industry elites, and the media participated in the meeting. The meeting involved 8 theme sharing, 1 This round table forum brought a very in-depth sharing feast for all participants.

Opening speech

Wang Yue, director of the Jiangsu Provincial Drug Administration, delivered a speech on behalf of the guiding unit. As a major review and approval breakthrough for the national medical device regulatory system, the medical device registrant system directly hits the “pain points” of enterprise development for a long time. After the implementation of the system, enterprises no longer have to bear the pressure of operating assets such as production equipment, personnel, and venues. They can invest more resources and energy in product development and innovation, which is conducive to accelerating the introduction and landing of innovative products. From the perspective of the industry, this is also conducive to the restructuring of enterprises, breaking through the constraints of land and environmental resources, and promoting the division and cooperation of the upstream and downstream of the medical device industry chain. He sincerely hopes that under the trial implementation of the medical device holder system, the Jiangsu medical device industry and the Suzhou high-tech zone medical device industry will usher in more opportunities and achieve faster development.

Lu Chunyun, deputy mayor of Suzhou Municipal People's Government, delivered a speech on behalf of the Suzhou Municipal People's Government and expressed warm welcome and gratitude to the experts and guests for their participation. Mayor Lu introduced the economic development of Suzhou and the development trend of the medical device industry, and pointed out The High-tech Zone has gathered dozens of innovation platforms such as the Institute of Medical Sciences of the Chinese Academy of Sciences, Suzhou Medical Device Research Institute of Southeast University, and Guoqian Medical Technology Innovation Research Institute. Give affirmation and point out that the content of this seminar is very important for the accumulation of more medical device industry resources.

On behalf of the organizer, Dr. Zhang Xu, Chief of the Medical Device Innovation Society, introduced the construction ideas and role positioning of the Medical Device Innovation Society under the background of the MAH system. Dr. Zhang Xu pointed out that the implementation of the medical device MAH system has subverted the industry's original production and R & D integration model. This will reshape the behavior of parties in the medical device ecological industry chain from the microscopic perspective and optimize resources from the macroscopic perspective. The configuration poses new challenges to supervision, which in turn leads to the reconstruction of the entire industrial structure. Dr. Zhang Xu introduced the development process of Yichuangsha and emphasized that it will continue to adhere to the concept of "cooperation, pragmatism, win-win and development" and become a platform and a platform for the exchange and integration of high-end innovation resources in the context of the MAH system Societies with positive externalities and an innovative, non-governmental think tank with certain influence have contributed to the high-quality development of China's medical device industry.

Theme report

Mr. Wang Baoting, deputy secretary-general of the China Society for Drug Administration and the former director of the Medical Device Supervision Department of the State Drug Administration, published a theme report entitled "Progress in the Pilot System of China's Medical Device Registration System"

Mr. Zhang Xinghua, Director of the Medical Device Manufacturing Supervision Department of the Jiangsu Provincial Drug Administration issued a theme report entitled "Discussion on the Supervision Mode under the Medical Device Registrant System"

Mr. Li Zhiyong, Secretary General of China Medical Equipment Association, published a theme report entitled "Construction and Development of Medical Device Innovation System"

Mr. Jiang Haihong, a specially-appointed regulatory expert of China Medical Device Industry Association and a participant in national medical device regulations and policies, published a theme report entitled "Problems to be Solved in the Implementation of the Medical Device MAH System"

Mr. Cao Changqing, Chairman of Juyi Medical Technology (Suzhou) Co., Ltd., delivered a theme report entitled "Medical Device CDMO Service Practice and Exploration"

Mr. Zhang Feng, Chairman of Aoxida Medical Device Group, published a theme report entitled "How to respond to the medical device registrant system under the new trend"

Mr. Wang Haijiao, VC Investment Partner of Shanghai Gaotejia Investment Management Co., Ltd., delivered a theme report entitled "Medical Device MAH System and Investment Opportunities"

Mr. Luo Liangjian, Quality Manager of Medtronic Greater China, delivered a keynote report entitled "Change in Registrant's Operating Model and Related Derivative Problems"

Round Table Forum

The forum guests discussed the system dividends that enterprises can enjoy in the context of the MAH system, the difficulties encountered in production, operation and management practices, such as how to coordinate the quality management system between the entrusting party and the trustee, and exchanged solutions to the problems. At the same time, the guests also expressed concern and understanding that registrants must bear the full life cycle responsibility of the product, and they have firmly believed in the future good development prospects of the medical device industry. The atmosphere was lively.

Leaders of Jiangsu Provincial Drug Administration Bureau answered questions for participants in the round table forum

Conclusion

As the first high-end seminar undertaken after the establishment of the Medical Device Innovation Society, the "Medical Devices MAH System Frontier Issues" Strategic Seminar was supported by the Suzhou High-tech Zone Management Committee. Establishing an influential cross-disciplinary and interdisciplinary high-end exchange and mutual assistance platform with industry influence is the purpose of the establishment of the medical and creative society. It integrates industry, academic, research, capital, hospital, regulatory and other essential resources to help the rapid growth of each member unit. The development of the national medical device field plays a unique role in promoting.

The successful convening of this meeting is conducive to assisting medical device-related companies to gain a deeper understanding of the connotation and regulatory trends of MAH, and at the same time, it has strengthened in-depth exchanges among various parties in the medical device ecosystem. Promote the innovation and high-quality development of the medical device industry and provide intellectual support.

Seminar Highlights