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Medical equipment is near the outbreak of the field, the state to speed up the approval of innovative equipment

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China is promoting the medical device review and approval system reform, through the special approval of medical equipment approval procedures to solve the problem of medical equipment approval congestion, while promoting domestic medical equipment independent innovation.

September 10 at the "2016 (sixth) China Medical Devices Summit Forum", the State Food and Drug Administration, director of medical equipment registration, said Gao Guobiao, as of the end of June, Food and Drug Administration received a total of Innovative medical equipment special approval application 379, completed the review of 356, 63 products to determine the entry into the special approval of innovative medical devices, of which 16 products have been approved. Medical equipment, technological innovation and industrial development, is in a huge period of change and the opportunity period.


China Pharmaceutical Industry Information Center released the 2016 China Health Industry Blue Book shows that the medical device industry is the health industry, the fastest growing areas, has become the capital market is one of the most promising investment hot spots. "Twelfth Five-Year" period, China's total market for medical devices from more than 120 billion yuan in 2010 increased to 300 billion yuan in 2015, an average annual growth of more than 20%. It is expected that by 2019 the total size of medical devices will be doubled again to reach the size of about 600 billion yuan.

Suzhou biological nano-park president Pang Junyong is the first financial reporter said that the medical device industry has reached the eve of the outbreak, I believe that another 2, 3 years will usher in changes. The park has a number of innovative medical device products into the innovative medical device special approval channel.

An intuitive manifestation of industrial development is the increase in the number of medical device registrations. In 2005, the State Food and Drug Administration approved a total of 7,030 medical device registration. In the first half of 2016, the General Administration of the People's Republic of China approved a total of 3,341 registered medical devices, of which 1135 were registered for the first time. If the medical products were classified according to the registered varieties, 2217 medical instruments, Is 2410, the provincial bureaus approved the territory of the second category of medical equipment registered 6139, of which the first registration of 3026 items.

In order to promote the innovation of medical equipment, the State Food and Drug Administration and the relevant departments of the State Council are studying, the organization drafted the "medical device priority approval procedures." Those who are included in the national science and technology major projects or national key research and development programs of medical equipment, or meet the requirements of some of the circumstances, can enter the priority approval.

Medical technology, medicine, medical equipment is the three major parts of medical services, including medical equipment is to promote the health industry, affecting the health care system reform and future health reform trends an important factor, but for a long time to Philips, Siemens, GE " GPS ", occupying most of the space in the market.

The United States, the European Union, Japan is a powerful power of medical equipment, almost monopolized the world's large, high-end, high-quality, innovative medical device market. Which the United States, the EU's medical industry scale to occupy the global market size of nearly 70%. If coupled with Japan and China, this ratio is nearly 90%. But an objective reality is that China's medical device industry is still in the primary quantitative development period, the large number of enterprises, small economies, especially in the high-end manufacturing short board obvious.

Shenzhen is one of China's high-end medical equipment business gathering place, more than 500 enterprises, all the output value of more than 300 billion yuan, but the output value of more than 100 million yuan of enterprises, only 40. In the country, China's current medical equipment manufacturing enterprises 14924, of which the output value of less than 20 million yuan of enterprises, accounting for nearly 90%.

"From the industrial scale of China's largest medical device business annual income of 1 billion US dollars, only the world's largest medical device business 1 / 20. From the product technology point of view, in the mainstream high-end large-scale innovation and other medical devices, the gap remains Very big. "Gao Guobiao said.

At present, China's medical equipment industry, still to imitation of production capacity, technological transformation-based, high-end monopoly is still rare, new innovation is still in the cultivation stage. And therefore, to promote the polymerization of science and technology and capital concentration, is the future of the medical device industry by the big and stronger key.

The next five years, Gao Guobiao said that the field of medical equipment will be three breakthroughs, including medical robots, wearing medical equipment, mobile and remote medical equipment, radiation therapy equipment and other areas need to vigorously promote. The second is to seize the frontier, the need to explore the research areas, such as genomics research, gene sequencing technology and gene editing technology, bio-electronic medical and cell therapy technology. Third, the integration of resources, nurture medical equipment + medical services in the field.
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