Product Analysis of China’s Medical Device Market in 2021
I. Approved class II and III medical devices:
In 2021, NMPA and provincial drug administrations approved 32450 class II and III medical devices, including 13326 first registered products and 19124 continued registered products. The first registered products accounted for 41.1%, lower than 57.1% in 2020.
In terms of geographical distribution, the top five provinces (regions and cities) in the number of approved class III devices were Beijing, Jiangsu, Guangdong, Shanghai and Shandong respectively, the top five provinces (regions and cities) in the number of approved class II devices were Guangdong, Jiangsu, Zhejiang, Hunan and Henan respectively, and the five provinces (regions and cities) with the highest proportion of class III devices were Shanghai, Fujian, Beijing Tianjin, Gansu and Shanghai accounted for 31.7%.
II. Special review of innovative medical devices：
As of December 31, 2021, CMDE has publicized 357 products included in the special review procedure for innovative medical devices, and a total of 120 products have been approved for listing through the procedure.
Eight apps made the cut, a record high. A total of eight medical software items were included in the special review process for innovative medical devices in 2021, a record high, including two items from Both Medicalcare and Shanghai. The selected medical software mainly included two categories of application scenarios: image-assisted diagnosis and surgical planning.
Beijing, Shanghai, Guangdong, Jiangsu and Zhejiang accounted for more than 80%. In addition to 12 imported products, among the remaining 48 medical device products included in the innovation process in 2021, Beijing, Shanghai, Guangdong, Jiangsu and Zhejiang accounted for 40, accounting for 83.3%, and the other 8 products were distributed in Sichuan, Hubei, Hunan, Liaoning and Shandong respectively.
III. Priority approval of medical devices:
As of December 31, 2021, CMDE has publicized 59 products included in the priority approval procedure for medical devices, and a total of 33 products have been approved for listing through the procedure.
Domestic varieties account for more than 60% of the priority approved products. Among the products that were given priority in approval and publicity in 2021, there were 10 domestic varieties, accounting for 71.4% of all publicity varieties; there were 4 imported varieties, accounting for 28.6%.
“Included in the national key R &D plan” is still the main reason for selection. From the reasons for the selection of publicity products in 2020, the products “listed in the national key R & D plan” account for 43% of all publicity varieties, which is still the main reason for the selection at present, followed by 29% of “clinically urgently needed” products.
Source：Author |Zhao Chenglong ，Aimed
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