15071 | Medical equipment for the first time in the national registry product statistics
According to MDCLOUD statistics, a total of 15,071 medical device products were registered for the first time nationwide in 2022, an increase of 1,345 compared with 13,726 in 2021, with a year-on-year growth of 9.8%.
Figure 1. The first registration of medical devices in China in 2018-2022
Data Source:MDCLOUD
Among them, 13,228 were registered for the first time in Class Ⅱ, accounting for 88%; Class III registered 1,843 cases for the first time, accounting for 12 percent.
Figure 2. Number of Class II and Class III medical devices registered for the first time in China in 2022
Data Source:MDCLOUD
01 Distribution of segments
In terms of segments, in vitro diagnostic reagent products had the largest number of initial registrations in 2022, with a total of 4,548 cases, followed by 2,990 cases of infusion, nursing and protective devices, and 963 cases of dental devices. The lowest number of initial registrations were for radiotherapy devices and active implants, both 23.
02 Provincial ranking
Guangdong Province ranks first in the country for the initial registrations, with a total of 2381 pieces.
From the distribution of the number of medical device products registered for the first time in all provinces, Guangdong Province ranked first in 2381. Hunan Province ranked second with 2,169 cases; Jiangsu Province ranked third with 2,160 cases. The number of medical device products registered for the first time in the above three provinces far exceeds that of other provinces and cities in China.
In Hunan Province, 2,136 cases of Class Ⅱ were registered for the first time
In terms of the number of Class II products registered for the first time, Hunan Province ranked first with 2,136, followed by Guangdong Province with 2,061 and Jiangsu Province with 1,766.
In Jiangsu Province, 394 cases of Class III were registered for the first time
In terms of the number of Class III products registered for the first time in all provinces, Jiangsu Province ranked first with 394. Guangdong Province followed with 320 and Beijing with 254.
03 City rank
The total number of first registrations in Changsha is 1187, ranking first in the country.
In terms of the total number of first-time registrations, Changsha ranked first in the country with 1,187 cases. Shenzhen and Beijing ranked second and third with 1,118 and 719, respectively.
Changsha, Shenzhen and Guangzhou ranked the top three for the first registration of Class II products
In terms of the total number of Class II products registered for the first time in each city, Changsha ranked first with 1173; Shenzhen and Guangzhou ranked second and third with 918 and 545 cases, respectively. The other top 10 cities, where the gap in first-time registrations was not significant, were Changchun, Tianjin, Xinxiang, Beijing, Suzhou, Changde and Nanjing.
Beijing registered 254 Class III products for the first time, ranking first in China
In terms of the total number of Class III products registered for the first time in each city, Beijing ranked first with 254. Shenzhen and Shanghai ranked second and third with 200 and 174 cases, respectively. The other TOP10 cities are Suzhou, Tianjin, Changzhou, Hangzhou, Guangzhou, Nanjing and Xiamen.
04 Growth ranking
Yunnan Province led the growth in the number of first-time registrations
In 2022, Yunnan Province ranked first in terms of the growth rate of the first registration of medical device products among all provinces, with a growth rate of 200%, followed by Ningxia Hui Autonomous Region and Heilongjiang Province with 114% and 83% respectively. Guangxi Zhuang Autonomous Region, Inner Mongolia Autonomous Region and Gansu Province followed.
The growth rate of the first registration of Class II products in provinces/autonomous regions exceeded 100 percent
In 2022, Yunnan Province ranked first in the number of first-time registrations of medical device class II products in all provinces, with a growth rate of 200%. Gansu Province and Ningxia Hui Autonomous region ranked second and third with 115% and 114% respectively. Guangxi Zhuang Autonomous region, Heilongjiang Province and Inner Mongolia Autonomous region followed.
The number of class III products registered for the first time in Chongqing has increased by 425%.
In 2022, Chongqing ranked first in terms of the growth rate of the first registration of Class III medical devices in all provinces, with a growth rate of 425%, followed by Anhui Province and Yunnan Province with 220% and 200%. Shaanxi, Hunan and Shanxi provinces followed.
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Source| Medical device data insight
Edited & Translated |Bradyknowns