State Food and Drug Administration: 4441 pharmaceutical and 17000 medical equipment manufacturers respectively

Recently, the State Drug Administration issued the annual report on drug regulatory statistics 2018 (hereinafter referred to as the annual report), which shows that by the end of November 2018, there were 4441 pharmaceutical raw materials and preparations manufacturers nationwide, and 17000 medical device manufacturers Statistics of production and operation licenses of drugs and medical devices by the end of November 2018, there were 4441 enterprises producing APIs and preparations nationwide, 65 more than last year's 4376 There are 508000 licensed enterprises in the national drug trade license, including 14000 wholesale enterprises, 5671 retail chain enterprises, 255000 retail chain stores and 234000 retail pharmacies Compared with last year, the number of medical device manufacturers increased significantly By the end of November 2018, there were 17000 medical device manufacturers nationwide, 1000 more than 16000 at the end of November 2017 Among them, there are 7513 enterprises that can produce class I products, 9189 enterprises that can produce class II products and 1997 enterprises that can produce class III products There are 511000 class II and class III medical device enterprises in China 90 applications for listing of imported drugs have been approved, 235 registration of imported three types of medical devices have been made In addition to the production and operation license, the annual report also makes statistics on the registration of drugs and medical devices in 2018 According to the annual report, in 2018, SFDA approved 312 new drug clinical applications, 58 generic drug clinical applications and 464 production applications, 154 imported drug clinical applications and 90 listed ones In the field of medical devices, in 2018, 22167 domestic class I medical devices were registered, 1885 imported class I medical devices (including Hong Kong, Macao and Taiwan) were registered; 4402 domestic class II medical devices were registered for the first time, 668 domestic class III medical devices were registered for the first time; 358 imported class II medical devices were registered for the first time, including Hong Kong, Macao and Taiwan Australia and Taiwan) 235 class III medical devices were registered for the first time.