On March 1, 2018, the 2018 Annual Policy Conference and 9th Meeting-Plus of 6th Council of China Association for Medical Device Industry (CAMDI) was held in Beijing. Xu Jinghe, deputy commissioner of National Medical Products Administration (NMPA), Wang Zhexiong, director of Department of Medical Device Supervision, Wang Lanming, commissioner of Department of Medical Device Registration, Sun Lei, head of the Center for Medical Device Evaluation, Zhang Zhaofeng, director of Biomedicine Division, Department of S&T for Social Development, Ministry of Science and Technology, Gu Xuefei, associate research fellow of China National Health Development Research Center, National Health Commission, and deputy director of Medical Security Research Office, Ye Quanfu, director of Institute of Hospital Management, National Health and Family Planning Commission, along with other leaders and experts, attended this meeting and made keynote speeches. Zhao Yixin, president of CAMDI, presided over the conference. More than 600 CAMDI representatives attended the conference. The 9th Meeting-Plus of 6th Council was held in the same period.
A brief meeting was held in advance between Xu Jinghe (deputy commissioner of NMPA) and Wu Yuanbin, director general of Department of S&T for Social Development under Ministry of Science and Technology, with a focus on how to better develop innovative medical devices by creating a favourable environment, so as to facilitate the transition of China from a manufacturer of quantity to one of quality in medical device field.
On behalf of the association, the president Zhao Yixin extended sincere gratitude in his speeches to the attending leaders and guests for their support and understanding.
Deputy commissioner Xu Jinghe first expressed his congratulations to the opening of this conference, and then he mentioned the progress being made in 2018 in review and approval system, relevant laws and regulations, standard system, pilot medical devices registrant program, clinical management, risk governance, supervision and inspection and international influence of supervision. Xu pointed out that emphasis shall be laid to the safeguard and promotion of public health in medical devices administration in a new era, and by so doing, to pursue a high-quality development while ensuring safety of medical devices. Furthermore, Xu also made clear that we shall endeavor to realize the transition of China from a manufacturer of quantity to one of quality by sticking to the idea of risk-oriented, responsible and intelligent governance, seeking a scientific, legislative, international and modern medical device administration and adopting sustainable and targeted steps based on innovation, quality, efficiency, systematization and effect.
Director Zhang Zhaofeng introduced in his speech themed with Innovation Drives Medical Devices the innovation status of medical devices, as well as the strategical consideration and focus of Ministry of Science and Technology to strengthen innovation in medical devices. Zhang Zhaofeng stated that the medical devices serve as a core basis to build health security system, a transformative power to reform medicine pattern, and a focus in strategic emerging industries. In pursuing an innovation-driven growth, Ministry of Science and Technology will spare no effort to collaborate with other relevant departments, such as NMPA, to help China become an innovation superpower by combining each’s advantages in industry-university-research-inspection field.
With a focus on the medical devices supervision and management, director Wang Zhexiong briefed the headways in the medical devices supervision and management in 2018, and then expounded the key tasks for 2019 to perfect laws and regulations in supervision and management, risk management, production supervision and inspection, operation supervision, adverse event monitoring, casual inspection, supervision and management capacity, and international communication.
Commissioner Wang Lanming, under the theme of Progress in 2018 and Outlook in 2019 in the Reform of the Drug and Medical Device Review and Approval System, summarized the work of Department of Medical Device Registration in 2018 from 8 aspects, namely, medical devices innovation, amendment of Regulation on the Supervision and Administration of Medical Devices and its supplementary regulations, implementation of pilot medical devices registrant program, reform of clinical evaluation of medical devices, optimization of standard system of medical devices, enforcement of new version of classification catalogue and unique device identification (code).
He added that in 2019, efforts would also be made to strengthen registration management system, simplify review and approval, welcome innovation in medical devices, optimize management in clinical trial, etc.
Sun Lei, head of the Center for Medical Device Evaluation, made a speech themed with “Review Status in 2018 and Direction in 2019 of Center for Medical Device Evaluation”, presenting the overall situation of evaluation in 2018, along with the progress of reform of review and approval system and the implementation of streamlining administration, delegating power, strengthening regulation and improving service. In his speech he pointed out that Center for Medical Device Evaluation in 2019 would continue to pursue a scientific evaluation, reform review and approval system, put the reform outcomes into practice, and better perform its duties to amend laws and regulations, promote reform, prevent and control risk, and conduct scientific and intelligent supervision.
In the speech themed with “Reform of Medical Insurance: Passive Payment to Strategic Purchase”, the associate research fellow and deputy director Gu Xuefei, by analyzing the advantages and disadvantages of three medical insurance payments, elaborated the implication of strategic purchase. Gu Xuefei stressed that strategic purchase means that medical insurance fund and resources will be allocated based on performance and health demands of the public respectively. Strategic purchase, characterized by efficiency, quality and safety, aims to maximize the health outcomes of insured population.
The conference in the afternoon was presided over by secretary general Xu Shan.
Director Ye Quanfu, under the topic of “Quality Management and Safety of Medical Devices in Hospital”, analyzed the common adverse device events in hospital to demonstrate the new direction in device management. In his speech, the medical device management, as an essential part of hospital management, entails the participation of departments of R&D, production, procurement, maintenance, etc. Only when a life-cycle management is achieved will the medical service be lifted.
Jiang Feng, the standing vice-chairman of CAMDI, as well as the president of China Alliance of Medical Device Technology Innovation, briefed the annual report of 2018 from “aspire to excellence through innovation-driven efforts; assist the government in industry management and service; escalate the level of member service; expand international cooperation; strengthen industry self-discipline and advance self-construction”. Jiang Feng mainly introduced the work plans in 2019 for CAMDI and China Alliance of Medical Device Technology Innovation.
Then, the 9th Meeting-Plus of 6th Council was held, in which the proposal of branch organization adjustment was reviewed and approved.
The conference was greatly supported by Shinva Medical Instrument Co., Ltd., Johnson & Johnson (China) Medical Co., Ltd., Z-Park Daxing Bio-medicine Industry Park, China Minimally Invasive Surgical Instrument Town, Roche Diagnostics Shanghai Ltd., BD Medical (Shanghai) Co., Ltd., and Zhongke Meiling Cryogenic Technology Co., Ltd.
