The medical device sector is approaching the eve of the outbreak as the country accelerates the approval of innovative devices

China is promoting the reform of the medical device review and approval system, solving the problem of congestion of medical device approval through innovative medical device special approval procedures, and promoting the independent innovation of domestic medical devices.
At the 2016 (6th) China Medical Device Summit Forum held on September 10, Gao Guoxuan, deputy director of the Medical Device Registration Administration of the State Food and Drug Administration, said that as of the end of June, the General Administration of Food and Drug Administration had received 379 applications for special approval for innovative medical devices, completed 356 reviews, and identified 63 products to enter the special approval channel for innovative medical devices, of which 16 products have been approved.
" medical device technology innovation and industrial development, is in a huge period of change and opportunity. Gao said.
2016 Blue Book on China's Health Industry released by the China Pharmaceutical Industry Information Center shows that the medical device industry is the fastest growing sector in the health industry and has become one of the most promising investment hot spots in the capital market. During the 12th Five-Year Plan period, China's total medical device market grew from more than 120 billion yuan in 2010 to 300 billion yuan in 2015, an average annual growth rate of more than 20%. The total size of medical devices is expected to double to about 600 billion yuan by 2019.
Junyong, president of Suzhou Bionamical Park, told first financial reporters that the medical device industry has reached the eve of the outbreak, I believe that in another two or three years will usher in great changes. Several innovative medical device products have entered the special approval channel for innovative medical devices in the park.
the development of the medical device industry is the increase in the number of medical device registrations. In 2015, the State Administration of Food and Drug Administration approved a total of 7,530 medical device registrations, and in the first half of 2016, the General Administration approved 4,341 medical device registrations, of which 1,135 were registered for the first time, of which 2,217 were medical devices, 2,410 were in-body diagnostic reagents, and 6,139 medical devices were approved by provincial bureaus, including 3,026 for the first time.
in order to promote the innovation of medical devices, the State Administration of Food and Drug Administration and the relevant departments of the State Council are studying and organizing the drafting of the Medical Device Priority Approval Procedure. Any medical device included in a major national science and technology project or a national key research and development plan, or in accordance with some prescribed circumstances, may enter into priority examination and approval.
Medical technology, pharmaceuticals, medical devices are the three major parts of medical services, of which medical devices are the driving force of the health industry, affecting the reform of the medical system and the future trend of medical reform, but for a long time, Philips, Siemens, GE composed of "GPS", occupies most of the market space.
, the United States, the European Union and Japan are powerful countries in medical devices, and almost monopolize the global market for large, high-end, high-quality and innovative medical devices, said Gao Guoxuan. Among them, the United States, the European Union's medical industry accounted for nearly 70% of the global market size. If you add Japan and China, the ratio is nearly 90%.
but an objective reality is that China's medical device industry is still in the primary quantitative development period, the number of enterprises, small economic scale, especially in high-end manufacturing is obvious.
Shenzhen is one of China's high-end medical device enterprises gathering place, more than 500 enterprises, the total output value of more than 30 billion yuan, but the output value of more than 100 million yuan of enterprises, only more than 40.
the country, china's medical device production enterprises 14924, of which the output value of 20 million yuan or less enterprises, accounting for nearly 90%.
" from the industrial scale of China's largest medical device enterprises annual revenue of 1 billion U.S. dollars, only equivalent to the world's largest medical device enterprises 1/20. From the product technology point of view, in the mainstream high-end large-scale innovation and other medical devices, the gap is still very large. Gao said.
Gao Guoxuan said that At present, China's medical device industry, still to imitation capacity-type, technology transformation-oriented, high-end monopoly is still rare, new innovation is still in the cultivation stage.
, promoting technology aggregation and capital concentration is the key to the future of the medical device industry from great strength.
In the next five years, Gao said, the medical device sector will make breakthroughs in three areas, including medical robots, wearable medical devices, mobile and remote medical equipment, radiation therapy equipment and other areas that need to be vigorously promoted. Second, grasp the forefront, the full need to explore research areas, such as genomics research, gene sequencing technology and gene editing technology, bioelectronics and cell therapy technology. Third, the integration of resources, the cultivation of medical devices and medical services in the field. (First Finance)