In 2022, 137 medical devices entered the innovation approval channel, with Beijing leading the way in terms of the number of Class III approved products
01 General Summary
According to the statistics of MDCLOUD, the number of Class Ⅱ and Ⅲ products entering the national innovative medical device special review procedure from 2014 to 2022 showed an overall rising trend, and the number of Class Ⅱ and Ⅲ products entering the innovation approval in 2022 totaled 137, the most in nearly 9 years. The number of approvals has also increased year by year, reaching 79 in 2022. Among them, 55 were Class III products and 24 were Class II products.
Figure 1 .Class II and III products entered and approved for special review of innovative medical devices in China from 2014 to 2022
02 Geographical Distribution
In terms of regional distribution, the approved products of Class Ⅲ innovative medical devices in 2022 were mainly concentrated in Beijing, Shanghai and Guangzhou. Among them, Beijing ranked first, followed by Shanghai, Guangdong and Zhejiang provinces. The total number of Class III innovative products approved was 44 in four provinces accounting for 80% of the total number of Category III innovative products approved by the country.
03 Segments
In terms of subdivided fields, active implantable devices (13) had the largest number of innovation approvals for Class Ⅲ products. Medical imaging devices followed with 12; There were 8 active and 8 passive surgical instruments. The most approved category for Class II products is medical imaging devices, with a total of 7 pieces, while injection, care and protection devices, ophthalmic devices, passive surgical devices, sterilization and sterilization devices, clinical testing devices, respiratory, anaesthesia and emergency devices, obstetrics and gynaecology, assisted reproduction and contraceptive devices are all 2 pieces.
04 Typical Enterprise
Among the 79 innovative products approved in 2022, 59 companies were involved. Pinsmedical has 11 Class III innovative medical devices approved, and InsightLifetech in Shenzhen,. United Imaging and Quanjingsheng (Beijing) have 2 Class III innovative medical devices approved. Shinva in Shandong, Xianzan in huizhou, Arsci (Zheng) has two Class II innovative medical devices approved.
