China is advancing the reform of the medical device review and approval system, and through solving the special approval procedures for medical devices, solving the problem of congestion in medical device approval, and promoting independent innovation of domestic medical devices.
At the "2016 (6th) China Medical Device Summit Forum held on September 10th, Gao Guozhen, deputy director of medical device registration management of the State Food and Drug Administration, said that as of the end of June, the Food and Drug Administration received a total of Innovative medical device special approval application 379, completed 356 reviews, identified 63 products into the special approval channel for innovative medical devices, of which, 16 products have been approved.
"Medical device technology innovation and industrial development are in a period of great change and opportunity." Gao Guozhen said.
The 2016 China Health Industry Blue Book published by 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 hotspots in the capital market. During the “Twelfth Five-Year Plan†period, the total medical equipment market in China increased from more than 120 billion yuan in 2010 to 300 billion yuan in 2015, with an average annual growth rate of over 20%. It is estimated that by 2019, the total size of medical devices will double again, reaching a scale of about 600 billion yuan.
Pang Junyong, president of Suzhou Bio-Nano Park, told reporters that the medical device industry has reached the eve of the outbreak, and I believe that it will be a great change in two or three years. The park has a number of innovative medical device products to enter the special approval channel for innovative medical devices.
A visual manifestation of industrial development is the increase in the number of medical device registrations. In 2015, the State Food and Drug Administration approved a total of 7,530 medical device registrations. In the first half of 2016, the General Administration of the People's Republic of China approved 4,341 medical device registrations, of which 1,135 were registered for the first time. According to the registered varieties, 2,217 medical devices, in vitro diagnostic reagents. It is 2410 items, and the provincial bureaus have approved a total of 6,139 registrations for the second category of medical devices in China, of which 3,026 are registered for the first time.
In order to promote the innovation of medical devices, the State Food and Drug Administration and relevant departments of the State Council are studying and drafting the "Approval Approval Procedure for Medical Devices". Any medical device listed in the National Science and Technology Major Project or the National Key R&D Program, or in compliance with some regulations, may enter the priority approval.
Medical technology, medicines, and medical devices are the three major components of medical services. Among them, medical devices are an important factor in promoting the health industry, affecting the reform of the medical system and future medical reforms. However, for a long time, it consists of Philips, Siemens, and GE. GPS", occupying most of the market space.
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