Forging a new engine   to stimulate new vitality

On December 18, 2020, the National Medical Products Administration announced that the innovative medical device "Vertebral artery rapamycin eluting stent system" produced by MicroPort Shentong Medical Technology (Shanghai) Co., Ltd. was approved for marketing. This is the 26th innovative medical device approved for marketing in my country in 2020, and it is also the 99th innovative medical device approved for marketing since February 2014 when the "Special Approval Procedure for Innovative Medical Devices (Trial)" laid the rapid approval channel for innovative medical devices. product.

In recent years, with the in-depth reform of my country’s medical device review and approval system, the medical device industry has maintained a good momentum of healthy and rapid development, innovative research and development vitality has burst, knowledge and information are interconnected, new technologies and new materials are cross-integrated, and innovative medical devices Accelerated emergence, to better meet the public's demand for machinery. my country's medical device industry is accelerating on the road of high-quality development.

Accelerated emergence of "intelligent manufacturing" products

In recent years, as market competition has become more intense and the international market is complex and volatile, my country’s medical device industry has achieved reasonable growth in quantity and steadily improved quality under the support of special review procedures and priority approval procedures for innovative medical devices. The equipment has achieved breakthroughs from following to parallel running in some areas.

The reporter has counted the innovative medical devices approved for marketing since 2014 and found that in 2020, the number of approved products will be the most, and some products will perform "eye-catching". For example, in January last year, my country's first domestically produced artificial intelligence medical device, Beijing Kunlun Medical Cloud Technology Co., Ltd.'s innovative product "coronary blood flow reserve score calculation software" was approved for listing. It is understood that this product adopts self-developed deep learning technology and is the world's first third-class medical device based entirely on artificial intelligence deep neural networks.

In 2020, the development of my country's artificial intelligence medical device industry will usher in a major breakthrough, industry technological breakthroughs and the pace of product implementation continue to accelerate, and good news of artificial intelligence medical device products are frequent. In addition to the above products, Lepu Medical’s artificial intelligence "ECG analysis software ”, MRI imaging-aided diagnosis software for intracranial tumors from Ande Medical Intelligence, “Diabetic Retinopathy Fundus Image Aided Diagnosis Software” from Shenzhen Silicon-based Intelligent Technology Co., Ltd., and “Diabetic Retinopathy Fundus Image” from Shanghai Yingtong Medical Technology Co., Ltd. Auxiliary diagnostic software, etc. have been approved for listing successively. Relevant statistics show that in 2020, 10 artificial intelligence medical device products in my country will be approved for listing (data as of December 16, 2020).

In recent years, my country has accelerated the pace of import substitution of high-end medical equipment, and the international market recognition has gradually increased. Wang Baoting, deputy secretary-general of the Chinese Society for Drug Administration and Chairman of the Medical Device Regulatory Research Committee, believes that my country's medical device foreign trade structure has continued to be optimized, the proportion of high-end medical device products has increased, and the quality and efficiency of products have continued to improve.

Statistics from the China Medical Insurance Chamber of Commerce show that my country's medical device import and export trade has maintained a continuous growth momentum for 11 years. In 2019, the export volume of medical devices was 28.702 billion U.S. dollars, a year-on-year increase of 21.46%. Local high-end medical equipment companies such as Mindray Medical, Neusoft Medical, Wandong Medical, United Imaging Medical have continuously promoted high-quality development through various methods such as talent introduction and technological innovation, and have gradually emerged in the international market.

Innovation-driven quality and efficiency

Medical devices are a complex industry that integrates multiple fields and technologies. The cross integration of new technologies, new tools, and new methods promotes innovation-driven medical device industry and promotes high-quality development.

In March 2020, my country's first medical device product "Glaucoma Drainage Tube" using domestic real-world data was approved for marketing, exploring the application of clinical real-world evidence collected in the Hainan Boao Lecheng Pioneer District to the clinical evaluation of medical device products. The application of real-world data greatly shortens the time required for clinical research and speeds up product launch.

Among them, there are not only technological and method innovations, but also policy support. In April 2019, the State Food and Drug Administration launched the China Drug Regulatory Scientific Action Plan, and "Methodological Research on the Use of Real World Data for Clinical Evaluation of Medical Devices" was one of the first batch of 9 key research projects; in June of the same year, the State Drug Administration The Bureau and the Hainan Provincial Government jointly launched a pilot project for the application of Hainan's clinical real-world data. The approval of the "Glaucoma Drainage Tube" is one of the pilot results.

The use of new tools in the medical device industry has 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 "Medical Device Unique Identification System Pilot Work Plan", officially launching the pilot work of the Medical Device Unique Identification (UDI) system. At present, UDI has penetrated all links in the production, operation and use of medical devices. On January 1 this year, the implementation of the first batch of UDI for medical devices will further enhance the precision management level of the entire life cycle of medical devices and boost the "three-medicine linkage".

In September 2020, the State Food and Drug Administration issued an announcement to recognize the application materials submitted for registration of imported medical devices, further simplify and optimize the structure of medical device conversion products, resolve registration problems caused by localized production of imported products, and greatly reduce conversion products Registration costs and shortening the registration time have accelerated the process of launching global technology-leading products in China. Yao Guoliang, General Manager of Roche Diagnostics (Shanghai) Co., Ltd. said: "The implementation of the policy will attract more international medical device companies to introduce the most advanced technologies, products and production capacity to China, to better serve Chinese patients and meet the health needs of the people. "

Collaborative innovation to promote development

The high-quality development of the medical device industry will ultimately rest on the "steady improvement of quality". Only technological progress and the enhancement of innovation capabilities can provide lasting impetus for industrial development.

The recently released "Recommendations of the Central Committee of the Communist Party of China on Formulating the Fourteenth Five-Year Plan for National Economic and Social Development and Long-Term Goals for 2035" conveys the main goals, priority areas and key tasks of my country’s development in the next five years, and promotes The domestic and international dual cycle, the implementation of innovation-driven development strategies, the comprehensive promotion of the construction of a healthy China, and the development of strategic emerging industries have clarified the development direction. "my country's medical device industry is ushering in a golden opportunity period." Yu Qingming, chairman of Sinopharm China Medical Devices Co., Ltd., said that the strategic thinking of innovation to drive high-quality development during the "14th Five-Year Plan" period will bring a new round of institutional innovation and industry Adjustment. He believes that for a period of time in the future, the medical device industry should focus on the extension of the entire industry chain and the coordinated development of upstream and downstream. It is necessary to strengthen the research and development of new materials, key technologies and core components, and realize the simultaneous innovation of high-end medical device complete machines and core components; It is necessary to combine peace and war to improve the industrial layout and emergency reserve system, and strive to build a world-class high-end medical device industry cluster.

Policy changes drive the innovation and transformation of the medical device industry-the reform of the review and approval system is deepened, and innovative products are launched faster; the pilot system of medical device registrants is "unbound" for research and development and production, and the pace of enterprise innovation is accelerated; two-invoice system, centralized procurement, etc. Policies continue to advance, and industry concentration continues to increase.

The innovation of medical device supervision will also further promote the development of the industry. In November 2020, the State Food and Drug Administration issued the "Technical Guidelines for the Use of Real World Data in the Clinical Evaluation of Medical Devices (Trial)", which became my country's first technical guidance document that regulates and guides the application of real world data in the clinical evaluation of medical devices. "Only through a standardized methodological system and interdisciplinary, can we build a high-quality real-world data system, and then generate high-quality real-world evidence to support medical device regulatory decision-making. It is expected that all practitioners in the medical device industry will strengthen the integration of technology and decision-making needs. , To promote the transformation of real-world research results.” said Sun Xin, director of the China Evidence-Based Medicine Center, West China Hospital, Sichuan University.

At present, my country's drug regulatory scientific action plan is being carried out in an orderly manner to provide new systems, new tools, new standards, and new methods for the review and supervision of drugs and medical devices, and to promote my country's progress from being a big country in manufacturing to a powerful country in manufacturing.