Breaking the foreign monopoly, Hubei enterprises 6 won the national medical device innovation approval

Editor:宏冠生物药业有限公司 │ Release Time:2018-11-20 

Medical Network November 20th Breaking the "foreign monopoly", medical equipment innovation in Hubei Province began to exert its strength. On November 16, the Food and Drug Administration of the People's Republic of China sent a gratifying news. Since 2016, the technological innovation potential of medical equipment enterprises in our province has been released, and 6 of them have been approved by the state's innovative medical devices.


The six medical device innovation projects are Habo Technology's liver reserve function tester, Yaxin Technology's pulmonary valved valve, Yangsen's three-layer bionic small-caliber artificial blood vessel, and Sharp Digital's all-digital positron emission and X Ray computed tomography scanning system, pre-implantation chromosome aneuploidy detection kit of Huada Bio, BRCA1/2 gene mutation detection kit. This means that local medical device companies say goodbye to the simple and crude imitation road, and rush to the road of innovation and head for a promising future.


At present, modern medicine is accelerating the rapid development of early detection, precise diagnosis, minimally invasive treatment, individualized diagnosis and treatment, intelligent services, etc., combined with multiple factors such as favorable policies, upgrading of manufacturing capacity and capital promotion, China's medical devices. Innovation entered the "golden 10 years." It is predicted that the size of China's medical device market will exceed 600 billion yuan in 2019, and innovation will become the most important driving force for its rapid growth.


Our province has obvious advantages in science and education, complete industrial support, and good conditions for developing the medical device industry. By the end of 2017, there were 616 medical device manufacturers in the province, with a total of 1881 records for Class I products and 1,487 Class II and III registered products, covering 30 clinical inspection and analysis instruments, orthopedic implants, medical polymer materials and products. category.


In addition to the above six items, companies are seeking breakthroughs in technological innovation. Wuhan Landing Company's automatic cell DNA detection analyzer obtained the US FDA market access qualification; Youkang Science and Technology's intelligent kidney mirror removes all stones in the patient's kidney at one time, the world's first; Wuhan Huada Gene's second generation gene sequencer It became the first approved clinical gene sequencing diagnostic equipment in China.


According to the "Hubei Province Medical Device Manufacturing Enterprise Development Report", the number of patented medical device manufacturers surveyed has a total of more than 400 patent certificates, with an average of 4 companies per company. The patent concentration of high-tech enterprises is also gradually increasing. Only the orthopedic implant manufacturer Wuhan Degebyer has 26 patent certificates.