A number of innovative medical devices are on the market, and the 2018 medical device landscape is open!
The medical device industry is today's high-tech industry, which has always been valued by various countries. China's medical device industry started late, but it is developing rapidly. With the drive of the national economy and the further improvement of human medical needs, China's medical devices must find a new development pattern under the new situation and strive to move forward steadily. Review the development prospects of medical devices under the policy structure In recent years, in response to the development of medical devices, the relevant state agencies have made precise efforts to continuously optimize and improve their policies, and they have never been taken lightly in terms of supervision. The CFDA regulatory history is shown in the following figure, looking at the development from 1998 to 2018. In the course of the process, food and drug supervision has changed step by step, but the emphasis on medical devices has never been put down. CFDA regulatory history Today (March 28), the General Administration of the People's Republic of China issued the "2017 Medical Device Registration Work Report" (hereinafter referred to as the report), which summarizes the registration management and supervision of the medical device industry in 2017. We can see that China's medical device registration management The regulatory system, the review and approval system, and the supervision and management system are gradually improving, providing basic guarantees for the development of medical devices. With the support of regulatory policies, the development prospects of medical devices are expected. The enlightenment of the 2017 registration pattern to 2018 (1) Acceptance of registration and approval in 2017 In 2017, a total of 6834 applications for medical device registration, renewal registration and licensing change were accepted, and the number of registration acceptance items decreased by 23.4% compared with 2016. A total of 8923 registration items for medical device registration, renewal registration and licensing matters were approved. Compared with 2016, the total number of registered approvals increased by 3.1%. It can be seen from the data that there are relatively many third-class medical devices in China. In addition, the provincial food and drug regulatory authorities have approved 18,582 second-class medical device registrations in China, and we can see that the development potential of domestic medical devices is good. 2017 General Administration of Medical Device Registration Acceptance Status Registration of second-class medical devices in various provinces Longitudinally, between 2013 and 2017, the Directorate approved a small change in medical devices, which was slightly higher in 2017 than in 2016. Approved registration in 2013-2017 Among the registration types, the continuation registration is the main one, and the approval and acceptance are more continuation applications. The number of acceptance and approval of the first registration application is relatively small. 2017 General Administration of Medical Device Registration Application Types The registered varieties were mainly medical devices, 4748 cases were accepted, 5475 items were approved, 2086 in vitro diagnostic reagents were accepted, and 3178 items were approved. 2017 General Administration of Medical Devices Registered Species Classification (2) Domestic and imported major registered varieties As can be seen from specific varieties, the number of registered medical devices in the third category is mainly: medical polymer materials and products, implant materials and artificial organs, injection puncture devices, medical optical instruments, instruments and endoscope equipment, operating rooms, Emergency room, treatment room equipment and appliances. The number of imported medical devices registered is mainly: implant materials and artificial organs, medical optical instruments, instruments and endoscope equipment, dental materials, medical polymer materials and products, medical electronic equipment. It can be seen that the domestic market has a large demand for medical polymer materials and products, implant materials and artificial organs, medical optical instruments, instruments and endoscope equipment. Compared with 2016, domestic medical polymer materials and products increased by 56.5%, jumping from the second to the first place, implant materials and artificial organs products fell by 10.5%, ranking second, medical optics Appliances, instruments and endoscope equipment are flat. Imported materials and artificial organs products still ranked first, down 5.1% year-on-year, medical polymer materials and products decreased, and dental materials increased by a large margin, replacing the operating room and emergency room. , the treatment room equipment and appliances entered the top five. It can be seen that in medical polymer materials and products, the country is developing rapidly and has occupied a major position. Ranking of the third type of medical device registration in China Imported medical device registration type ranking chart (3) Number of regions approved for registration in 2017 As can be seen from the distribution of major regions, our import source is mainly the United States. The third type of medical devices in China are mainly developed areas in Beijing, Jiangsu and Guangdong. Imported medical device country registration ranking map Ranking of the third-class medical device registration provinces in China (4) Examination and approval of products for innovative medical devices and other products In 2017, the Food and Drug Administration approved the listing of some innovative medical device products. In the whole year, 273 special applications for innovative medical devices were received, and 323 reviews (including 2016 applications) were completed, and 63 products were identified as special approval channels for innovative medical devices. 12 innovative products such as the registered branch aortic stent graft and delivery system were approved for marketing. Among them, there are 4 active medical devices and 8 passive medical devices, with a total increase of 2 compared with 2016. The core technologies of these innovative products have China's invention patents or invention patent applications have been disclosed by the patent administration department of the State Council. The main working principle/action mechanism of the products is the first in China and has significant clinical application value. Overview In 2017, the review and approval of medical device registration review, we can see that the trend of domestic registration review in 2017 is good. On many high-tech medical device products, the number of domestic registrations has surpassed imports, and the state supports innovative product policies. It is worth looking forward to making more products appear or appear on the market. In 2018, in the face of new domestic and international changes, the medical device industry should pay more attention to its own development, and strive to let China's high-value medical device industry move from the stage of absorbing the technological advantages of developed countries to its own stage of innovation. Starch Vegetable Empty Capsule Starch Vegetable Empty Capsule,Empty Vegetable Capsules Size 00,Hydroxypropyl Starch Empty Capsules,Starch Empty Hard Capsules Ningbo Jiangnan Capsule Co., Ltd. , https://www.ningbocapsule.com
