China Medical Device Industry Association Medical Polymer Products Branch "Medical Devices - Polymer 2019 Annual Meeting and International Medical Consumables Industry Development Forum" Held in Yiwu, Zhejiang
From March 27th to 28th, 2019, the Professional Branch of Medical Polymer Products of China Medical Device Industry Association organized the "Medical Device-Polymer 2019 Annual Conference and International Medical Consumables Industry Development Forum" in Wanda Realm Hotel, Yiwu, Zhejiang! Director of the Equipment Supervision Department of the State Drug Administration, Director Wang Weijun, Director of the Food and Drug Administration and Inspection Center, Mr. Wang Aijun, Director of the Institute of Medical Device Standards Management, China Food and Drug Administration, Yu Xinhua, Deputy Director of the National Center for Drug Policy Research, Chinese Medicine Professor Ding Jinxi, Vice President of Dafa College, Mr. Gao Lingyun, Center for Environmental Protection Cooperation of the Ministry of Environmental Protection, Huang Xiaomei, Deputy Director of Yiwu Municipal Market Supervision Bureau, Wang Guocheng, Director of Yiwu High-tech Zone, Leaders of Branches, Experts, Representatives of Testing Organizations, Representatives of Member Units, etc. More than 500 people from more than 200 companies across the country attended the meeting.
Branch Secretary-General Li Weiyang, Vice Chairman of Shanghai Kangdelai Enterprise Development Group Fang Jianhong, General Manager of Zhejiang Lingyang Medical Devices Co., Ltd. Hu Junfei, and Vice President of Henan Camel Medical Devices Group Co., Ltd. Liu Yanhong hosted four meetings on 27 and 28 respectively.
Director of the High-tech Zone of Yiwu City, Mr. Wang Guocheng delivered an opening speech. He was very pleased that the industry conference was held in Yiwu, Zhejiang Province, and expressed warm welcome to the arrival of the delegates! In recognition of the advanced and further enthusiasm for the work of the association, there were six “excellent governing units” such as Shandong Xinhua Ande Medical Products Co., Ltd. and Jiangsu Yabang Tianlong Medical New Materials Co., Ltd., which were limited to Camel Holdings Group. The company, Hangzhou Kebaite Filter Equipment Co., Ltd. and other six "advanced units of standardization work", six "association work advanced individuals" such as Tian Xiaolei, Liu Yanhong, Bao Yi, and six "standardization work" such as Wang Youqiong, Hu Zhengfang and Xing Yushan Advanced individuals have been commended.
Chairman Wang Yi made a report on the work of the club at the meeting. First of all, on behalf of the 4th Council, he expressed warm welcome and sincere thanks to the leaders, guests and representatives of the member units! Subsequently, the work of the 2018 branch was comprehensively and objectively summarized, and the main work of 2019 was specifically and explicitly deployed. He emphasized that Premier Li Keqiang made important instructions on national medical work in the government work report. He hoped that enterprises should adapt to changes in national industrial policies, not just to meet the production of low-end medical consumables, and to continuously carry out product innovation and overcome Product homogenization, transformation to high value-added consumables; to meet the needs of the people's medical health and the pursuit of a better life as their responsibility, and promote the healthy development of the medical device industry.
Director Wang Hao of the Equipment Supervision Department of the State Drug Administration made an important speech at the meeting, which explained the national regulatory policy and supervision direction in detail, and hoped that the enterprise could do a good job in the quality management of medical device production and operation in 2019.
In the report, Director Wang Aijun of the Food and Drug Administration of the State Drug Administration announced the key issues of the medical device flight inspection in 2018. Based on the general principle of “double randomness and openness”, the risk of the company’s concerns was Analysis; at the same time, the flight inspection plan of 2019 was explained in detail. It is hoped that all enterprises will make relevant preparations, and they will make a correct rectification for the enterprise itself and respond to the flight inspection in 2019.
On the afternoon of March 27th, Professor Ding Jinxi, deputy director of the National Center for Drug Policy Research and vice president of the China University of Pharmaceutical Sciences, shared the impact of the national new medical reform on the three aspects of medical device registration management, medical insurance management and procurement management. Two trends in the development of device supervision: 1. Encourage innovation: enable more innovative medical devices to enter clinical use, improve the level of therapeutic services and curative effects, improve the quality of life of patients, and promote the development of the device industry. 2. Sustainable development of medical insurance funds: Control medical device expenses by means of medical insurance catalog management, medical insurance payment reform (DRGs), and procurement management.
Director Yu Xinhua from the Institute of Medical Device Standards Management of China Food and Drug Control Research Institute introduced the basic situation of national standardization reform during the release of the “Deepening Standardization Work Reform Plan” in 2015 to the January 2019 “Group Standard Management Regulations”. The medical device standard management and regulation system and the next step of the medical device standards "put", "management", "service" work ideas.
Qin Ying, the head of the static treatment group of the Sichuan Cancer Hospital, introduced the safety of clinical use of disposable infusion devices. He explained in detail the positive and negative safety problems in the treatment of intravenous infusion, the evaluation content of active intravenous therapy and the choice of infusion tools. I have shared three aspects and shared valuable experience in designing and improving disposable infusion devices.
Jiang Chunpu, deputy general manager of Weigao Medical Products Group Blood Transfusion Technology Company, shared his experience in data analysis based on MES system. Develop in-depth applications centered on MES (Manufacturing Execution System), integrate data such as people, materials, machines, and fees, and use data analysis, evaluation, decision-making, and performance as the path of accuracy, timeliness, and relevance. Data creates synergistic value and forms a closed-loop management model with data assets as the core, using data-driven value creation.
Mr. Gao Lingyun from the Environmental Protection Foreign Cooperation Center of the Ministry of Environmental Protection explained the “HCFCs phase-out project” from three aspects: “China HCFCs Elimination Progress in the Cleaning Industry, China's Implementation of the International Convention for the Protection of the Ozone Layer, and the Next Steps for the HCFCs in the Cleaning Industry”. Everyone actively participated in the project and "protected the ozone layer" together.
On March 28th, thirteen enterprise experts gave keynote speeches on medical device testing technology, new materials and new technologies, packaging and sterilization, and conducted in-depth and detailed discussions to help companies better understand the latest technological progress. : 1. Bianxinxin Ultrasonic (Shanghai) Co., Ltd. medical industry sales manager Fang Wei shared the common problems and solutions of ultrasonic plastic welding principle and ultrasonic welding in welding materials, welding equipment, welding process, etc. 2, Abbott Machinery (Shanghai) Co., Ltd. engineer Chai Wenlong elaborated the efficient, stable and safe Arburg medical liquid silicone from three aspects: LSR injection molding process introduction, LSR injection mold design points, and clean room solutions provided by ARBURG. Injection molding solution; 3. Chen Chao, General Manager of Wenzhou Vico Biological Experimental Equipment Co., Ltd. from the definition of disinfectant, domestic and international disinfectant market supervision, domestic and international medical device production environment disinfectant regulations and requirements, the necessity of disinfectant effectiveness testing, etc. The aspects of the efficacy and application of the killer in the microbial control of the medical device production environment are shared; 4. Zhang Haikun, Maid Medical Industrial Equipment Co., Ltd. introduced the high-efficiency medical consumable automation equipment of Maid Company; 5. Mr. Yan Ge, Lubrizol Management (Shanghai) Co., Ltd., is mainly engaged in the application development and sales of polyolefin, styrene thermoplastic elastomers and polyurethane elastomers in the medical industry. At the meeting, the application of Lubrizol medical polyurethane products in high-risk medical devices was introduced and the actual cases were shared. 6. Minister Guo Zhanying of Beijing Yuji Technology Development Co., Ltd. explained in detail the application of IF-003 silicone oil thinner and its replacement of HCFC-141b in the disposable medical device industry, which provided better for the “HCFCs phase-out project” proposed by the Ministry of Environmental Protection. solution; 7. Dr. Yang Jiajia from Shanghai Micro-Spectrum Chemical Technology Service Co., Ltd. introduced the chemical characterization of materials based on the biological evaluation criteria of medical devices from the aspects of changes in biological evaluation regulations and regulatory trends, new changes in the chemical characterization process of materials, and implementation points of chemical characterization of materials. Thinking and practice; 8. The general manager of the Suzhou Industrial Park Model Ketai Mould Technology Co., Ltd. explained the high-quality molds and the adapted raw materials from the mold manufacturing aspect. 9. Wang Xingguo, deputy general manager of Beip Medical Technology Co., Ltd. shared the application, maintenance and troubleshooting of medical consumables hot runner molds; 10. Manager Wang Yi of Kesi Chuang (China) Co., Ltd. introduced the new type of polycarbonate, such as Makrolon, Bebenlan, Miao Benlan and Yaba, which were introduced by Covestro to strengthen the performance of intravenous infusion connector. Ester product 11. Huang Yimei, deputy general manager of Hengfangda Polymer Materials Technology Co., Ltd., from the market overview of medical polymer materials, the status quo of medical PVC materials at home and abroad, the safety of medical PVC materials, the technical development of medical PVC materials, medical PVC materials. The application development and other five aspects introduced the new trend of medical PVC material technology and application development; 12. Cao Kai, Product Development Manager of Pema Time Flexible Packaging (Suzhou) Co., Ltd. introduced the key factors considered in the aseptic shielding system, the testing methods of the gas permeable materials, the advantages and disadvantages of the rubberized products, extrusion and composite film materials, etc. Solutions in medical device packaging; 13. Su Shi, senior engineer of Baling Petrochemical Company of Sinopec Group Asset Management Co., Ltd., shared the history of SEBS, research and development process, SEBS characteristics and future development of large infusion. In addition, the conference set up a display area, and more than 50 companies demonstrated their scientific achievements and products on the spot.
The success of this conference fully reflects the cohesiveness and centripetal force of the medical polymer products branch!