The State Food and Drug Administration recently released data,In 2023, a total of 2,728 medical device products will be approved for registration。In December 2023, the State Food and Drug Administration approved a total of 343 registered medical device products. Among them, there are 266 domestic Class III medical device products, 37 imported Class III medical device products, 38 imported Class II medical device products, and 2 Hong Kong, Macao and Taiwan medical device products.
According to the data, in 2023, a total of 2,081 domestic Class III medical device products, 335 imported Class III medical device products, and 22 Hong Kong, Macao and Taiwan medical device products will be approved. Among them,61 innovative medical devices were approved, a year-on-year increase of 1090%, a new high.
Guo Changmao, deputy director of the Southern Institute of Pharmaceutical Economics of the State Food and Drug Administration, said that in 2023, a number of "national heavy devices" such as carbon ion ** system, proton ** system, and artificial heart will be successfully listed, constantly filling the gaps in China's related fields, and achieving breakthroughs in one "stuck neck" technology after another. By the end of 2023, 250 innovative medical device products have been approved for marketing in ChinaContinuously meet the growing health needs of the people.
According to the calculations of the Southern Pharmaceutical Economic Research Institute of the State Food and Drug AdministrationIn 2023, the operating income of China's medical device manufacturers is expected to be 131 trillion yuan, the industrial scale ranks second in the world. As of the end of November 2023, there are 3320,000, a year-on-year increase of 312%。Among them, there were 22,119 record certificates for the production of first-class products, a year-on-year increase of 118%；There were 15,605 licenses for the production of second-class products, a year-on-year increase of 109%；There were 3,038 licenses for the production of third-class products, a year-on-year increase of 2315%, the development of high-end medical device production accelerated.
In addition,By the end of 2023, there are a total of 1,974 medical device standards in China, including 271 national standards and 1,703 industry standardsIt covers all professional and technical fields of medical devices in China, and the consistency with international standards has reached 95%, and the coverage, systematization and international coordination of the standard system have been continuously improved.
At present, medical devices encourage innovation policy dividends. The "Action Plan for the High-quality Development of the Pharmaceutical Industry (2023-2025)" and the "Action Plan for the High-quality Development of the Medical Equipment Industry (2023-2025)" are proposedIt is necessary to focus on improving the resilience and modernization level of the pharmaceutical industry and medical equipment industry, enhance the supply capacity of high-end drugs, key technologies and raw and auxiliary materials, and accelerate the completion of China's high-end medical equipment shortcomings.
Guo Changmao believes that various departments have successively introduced policies to support and ensure the high-quality development of the industry, and the domestic market demand is strong, providing strong support for the development of the industry. The operating performance of listed medical device companies has been stable, the industrial concentration has been further improved, and the emergence of innovative achievements has accelerated, which has better met the health needs of the people. At the same time, the export scale of China's medical device products has returned to normal, the structure of export products has been optimized, and the international competitiveness has gradually increased, showing the broad space and strong impetus for the development of China's medical device industry.
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