In 2022, medical software was upgraded intelligently, and the number of registrations increased by 26.5% year on year, with image processing accounting for more than half

01.Registration of medical software products is growing at an accelerated pace

With the support of national policies, China’s medical software industry develops rapidly, and the market gradually develops to high quality and fine. According to MDCLOUD statistics, from 2018 to 2022, the number of valid medical software product registration certificates and the number of medical software-related enterprises in China increased steadily. In 2022, the number of valid medical software product registration certificates totaled 1,324, with a year-on-year growth of 26.5%; The number of medical software related enterprises totaled 748, with a year-on-year growth of 24.4%.

2. Guangdong, Beijing and Hunan ranked the top three in medical software registration certificates

In terms of registrations, Guangdong Province ranked first with 200 valid medical software product registrations in 2022, followed by Beijing (166), Hunan Province (130), Jiangsu Province (125) and Zhejiang Province (109).

3. Image processing software accounted for more than half

In terms of registration in 2022, image processing software ranked first, with a total of 809 registered cases, accounting for 61.9%, and 472 related companies, accounting for 57.9%, with year-on-year growth of 22.6% and 18.0%, respectively. In second place was data processing software, with a total of 168 registered cases and 130 related enterprises, up 32.3 percent and 36.8 percent, respectively. In vitro diagnostic software ranked third, with a total of 133 registered cases and 87 related companies, up 24.3% and 29.9%, respectively.

4. Artificial intelligence medical software is on the rise
   With the continuous development of the application of artificial intelligence in the medical field and the increasing market enthusiasm for related products, in July 2019, the NMPA released the Key Points of Evaluation of Medical Device Software for Deep Learning to Assist Decision making. In 2020, two basic general industry standards, Quality Requirements and Evaluation of Artificial Intelligence Medical Devices Part 1: Terminology, and Quality Requirements and Evaluation of Artificial Intelligence Medical Devices Part 2: General Requirements for Data Sets, have been established, laying a good start for standardization.

5. The number of registration certificates of Shanghai United Imageing ranked first

In terms of registrations in 2022, United Imaging Intelligence (UII) (15) and Yukuncloud(Beijing) (15) ranked first in the number of valid product registrations. Siemens Healthcare GmbH (11) and Genomics (Wuhan) (11) followed.

Source：Joinchain, MDCLOUD

Translated & edited :Bradyknows