On December 18, the State Drug Administration announced that the innovative medical device "vertebral artery rapamycin targeted eluting stent system" produced by minimally invasive Shentong medical technology (Shanghai) Co., Ltd. was approved for listing. This is the 26th innovative medical device approved for listing in China this year, and the 99th innovative product approved for listing since the establishment of the rapid approval channel for innovative medical devices in the special approval procedure for innovative medical devices (Trial) in February 2014.
In recent years, with the in-depth promotion of the reform of China's medical device review and approval system, the medical device industry has maintained a good momentum of healthy and rapid development, with the burst of innovation and R & D vitality, the interconnection of knowledge and information, and the cross integration of new technologies and new materials, so that more innovative medical devices have accelerated their emergence, Better meet the public demand for machinery - China's medical device industry is accelerating on the road of high-quality development.
Accelerated emergence of "smart" products
In recent years, under the circumstances of more fierce market competition and complex and changeable international market, China's medical device industry has achieved reasonable growth in quantity and steady improvement in quality with the support of innovative medical device special review procedures, priority approval procedures and other policies, and China's medical devices have made breakthroughs in some fields.
The reporter counted the innovative medical devices approved for listing since 2014. This year, the most products were approved, and some products performed "eye-catching". Now, in January, China's first domestic artificial intelligence medical device - the innovative product "coronary blood flow reserve score calculation software" of Beijing Kunlun medical cloud Technology Co., Ltd. was approved for listing. It is understood that the product adopts the self-developed deep learning technology and is the world's first three types of medical devices completely based on artificial intelligence and deep neural network.
In fact, this year, the development of artificial intelligence medical device industry has ushered in major breakthroughs, the pace of industrial technological breakthroughs and product implementation has been accelerating, and the success of artificial intelligence medical products has been reported frequently - in addition to the above products, the artificial intelligence "ECG analysis software" of Lepu medical, the magnetic resonance imaging assisted diagnosis software of intracranial tumors of ande medical, and the software of Shenzhen silicon-based Intelligent Technology Co., Ltd "Diabetic retinopathy fundus image assistant diagnostic software" and "Shanghai Ying Ying Medical Technology Co., Ltd." "diabetic retinopathy fundus image aided diagnostic software" and so on have been listed. Data statistics, as of December 16th, this year, 10 artificial intelligent medical device products were approved to be listed, domestic intelligent medical devices and other "intelligent manufacturing". The transformation of achievements is fast and steady.
In recent years, China's import substitution of high-end medical devices has accelerated, and the international market recognition has gradually improved. Wang Baoting, Deputy Secretary General of China pharmaceutical regulatory Research Association and chairman of Medical Device Regulatory Research Committee, believes that China's foreign trade structure of medical devices has continued to be optimized, the proportion of high-end medical device products has increased, and the quality and efficiency have continued to improve.
According to the statistics of China Medical Insurance chamber of Commerce, China's import and export trade of medical devices has also maintained a continuous growth momentum for 11 years. In 2019, the export volume of medical devices was US $28.702 billion, a year-on-year increase of 21.46%. Local high-end medical device enterprises such as Mindray medical, Neusoft medical, Wandong Medical and Lianying medical continue to introduce talents and technological innovation Two ways to promote high-quality development and gradually stand out in the international market.
Innovation driven quality improvement and efficiency increase
Medical device is a complex industry with multi fields and multi technology integration. The cross integration of new technologies, new tools and new methods promotes the innovation drive of medical device industry and promotes high-quality development.
In March this year, China's first medical device product "glaucoma drainage tube" using domestic real-world data was approved for listing, exploring the application of the clinical real-world evidence collected in the Pioneer Area of Lecheng, Boao, Hainan, to the clinical evaluation of medical device products. The application of real-world data has greatly shortened the time required for clinical research and accelerated the product listing.
In April 2019, the State Food and Drug Administration launched the scientific action plan of China's drug supervision, "methodological research on real world data for clinical evaluation of medical devices" It is one of the first nine key research projects; in June of the same year, the State Food and Drug Administration and Hainan Provincial Government jointly launched the pilot work of clinical real-world data application in Hainan. The approved listing of "glaucoma drainage tube" is one of the pilot results.
The use of new tools in the medical device industry has also promoted the orderly and efficient development of the industry. In July 2019, the State Food and Drug Administration and the National Health Commission jointly issued the pilot work plan for the unique identification system of medical devices , the pilot work of the unique identification of medical devices was officially launched. At present, the unique identification of medical devices has been through all links of the production, operation and use of medical devices. On January 1 next year, the first batch of unique identification of medical devices will be officially implemented, which will further improve the precision management level of the whole life cycle of medical devices and promote the "three medical linkage".
In September this year, the State Food and Drug Administration announced that it recognized the application materials submitted for the registration of imported medical devices, further simplified and optimized the conversion products of medical devices, solved the registration problems caused by the localized production of imported products, greatly reduced the registration cost of conversion products, shortened the registration time, and accelerated the listing of global technology-leading products in China Yao Guoliang, general manager of Roche diagnostic products (Shanghai) Co., Ltd., said: "the implementation of the policy will attract more international medical device enterprises to introduce the most advanced technology, products and production capacity into China, better serve Chinese patients and meet the health needs of the people."
Collaborative innovation and common development
The high-quality development of the medical device industry should ultimately rest on the "steady improvement of quality". Only technological progress and innovation ability can provide lasting impetus for industrial development.
The newly released "14th five year plan" conveys the main objectives, priority areas and key tasks of China's development in the next five years, and defines the development direction in promoting domestic and international double circulation, implementing the innovation driven development strategy, comprehensively promoting the construction of a healthy China and developing strategic emerging industries. "China's medical device industry has ushered in a golden opportunity period." Yu Qingming, chairman of Sinopharm China Medical Devices Co., Ltd., said, "the 14th five year plan" During this period, the strategic idea of innovation driving high-quality development will bring a new round of institutional innovation and industry adjustment. He believes that in the future, the medical device industry should focus on the extension of the whole industrial chain and the coordinated development of upstream and downstream, strengthen the research and development of new materials, key technologies and core parts, realize the synchronous innovation of high-end medical devices and core parts, and make peace and war Combined with the improvement of industrial layout and emergency reserve system, and strive to build a world-class high-end medical device industry cluster.
Policy reform drives the innovation and transformation of the medical device industry - the reform of the review and approval system is deepened, and innovative products are listed faster; the pilot of the medical device registrar system is "unbound" for R & D and production , the pace of enterprise innovation has accelerated; policies such as the two vote system and centralized procurement have been continuously promoted, and the industry concentration has been continuously improved. The innovation of medical device supervision will also further promote the industrial development. In November this year, the State Food and Drug Administration issued the guiding principles of real world data for clinical evaluation of medical devices (Trial) It has become the first technical guidance document to standardize and guide the application of real-world data in clinical evaluation of medical devices in China. "Only through a standardized methodology system and interdisciplinary, can we build a high-quality real-world data system and generate high-quality real-world evidence to support medical device regulatory decisions. It is expected that all practitioners in the medical device industry will strengthen the integration of technology and decision-making needs and promote the transformation of real-world research results." Sun Xin, director of China evidence-based medicine center of West China Hospital of Sichuan University, said.
At present, China's scientific action plan for drug supervision is being carried out in an orderly manner, providing new systems, new tools, new standards and new methods for the evaluation and supervision of drugs and medical devices, and promoting China's progress from a large country to a powerful country.
