China is promoting the reform of medical device review and approval system to solve the congestion problem of medical device approval through innovative medical device special approval procedures, and at the same time promote the independent innovation of domestic medical devices. At the "2016 (6th) China Medical Device Summit" held on September 10, Gao Guobiao, deputy director of medical device registration management of the State Food and Drug Administration (SFDA), said that by the end of June, the SFDA had received 379 applications for special approval of innovative medical devices, completed the review of 356, and determined that 63 The State Food and Drug Administration has received 379 applications for special approval of innovative medical devices, completed the review of 356, and determined that 63 products entered the special approval channel for innovative medical devices, of which 16 products have been approved to. "Medical device technology innovation and industrial development, is in a period of great change and opportunity." Gao Guobiao said.
The 2016 Blue Book of China's Health Industry released by China Pharmaceutical Industry Information Center shows that the medical device industry is the most rapidly growing area in the health industry and has become one of the most promising investment hotspots in the capital market. "During the 12th Five-Year Plan, China's total medical device market grew from more than 120 billion yuan in 2010 to 300 billion yuan in 2015, with an average annual growth of more than 20%. It is expected that the total scale of medical devices will double again by 2019, reaching a scale of about 600 billion yuan. For his part, Pang Junyong, president of Suzhou Bio Nano Park, told the First Financial Reporter that the medical device industry has reached the eve of an explosion and believes that another 2 or 3 years will usher in a huge change. The park has several innovative medical device products entering the special approval channel for innovative medical devices. A visual indication of the development of the industry is the increase in the number of medical device registrations. 2015, the State Food and Drug Administration approved a total of 7,530 medical device registrations, the first half of 2016, the General Administration approved a total of 4,341 medical device registrations, of which 1,135 were registered for the first time, if distinguished by the registered species, of which 2,217 were medical devices, in vitro diagnostic reagents were 2,410, the provinces Bureau approved a total of 6,139 registrations of Class II medical devices, of which 3026 were registered for the first time. In order to promote innovation in medical devices, the State Food and Drug Administration and the relevant departments of the State Council are studying and organizing the drafting of the "priority approval procedures for medical devices. Any medical device included in the national science and technology major special projects or national key research and development programs, or meet some specified circumstances, can enter the priority approval. Medical technology, drugs and medical devices are the three major components that make up medical services, of which medical devices are an important element in promoting the health industry and influencing the reform of the medical system and future trends in medical reform.
However, for a long time, Philips, Siemens, GE "GPS", occupying most of the market space. Gao Guobiao said, the United States, the European Union, Japan is a medical device powerhouse, almost monopolizing the global market of large, high-end, high-quality, innovative medical devices. Among them, the scale of the medical industry in the U.S. and EU occupies nearly 70% of the global market size. If we add Japan and China, the proportion is nearly 90%. However, an objective reality is that China's medical device industry is still in the primary quantitative development period, with a large number of enterprises and small economic scale, especially in high-end manufacturing shortcomings are obvious. Shenzhen is one of China's high-end medical device enterprises gathering place, more than 500 enterprises, all output value of more than 30 billion yuan, but the output value of more than 100 million yuan of enterprises, only more than 40. And in the country, China's medical device manufacturers 14924, of which the output value of 20 million yuan or less, accounting for nearly 90% of enterprises. "From the industrial scale of China's largest medical device enterprises annual revenue of $ 1 billion, only equivalent to the world's largest medical device enterprises 1/20. from the product technology, in the mainstream of high-end large-scale innovation and other medical devices, the gap is still large." Gao Guobiao said. According to Gao Guobiao, at present, China's medical device industry, is still dominated by imitation capacity type, technology transformation type, high-end monopoly is still a rare, new innovative is still in the cultivation stage. Therefore, the promotion of scientific and technological convergence and capital concentration is the key to change the medical device industry from big to strong in the future. In the next five years, Gao Guobiao said that the medical device field will make breakthroughs in three areas, one including medical robots, wearable medical devices, mobile and remote diagnosis and treatment equipment, radiation therapy equipment and other areas that need to be vigorously promoted. The second is to seize the frontier and make every effort to explore research areas such as genome research, gene sequencing technology and gene editing technology, bioelectronic medical and cell therapy technology. Third, integrate resources and cultivate the field of medical devices + medical services.