On October 30, the CMDE (Center for Medical Device Evaluation) of NMPA (National Medical Products Administration) announced their plan to draft the clinical evaluation and performance evaluation guidelines for AI software in diagnostic pathology. Both clinical evaluation and performance evaluation are part of the reviewing process of the product registrations in China.
According to the China’s Five-Year Plans and Made in China 2025, the development goals covered imaging equipment, AI robotics, wearables, remote diagnosis and treatment, etc. Based on reports from the NMPA, the medical imaging equipment currently takes up to 16% of the entire China medical device market. Also, 80% of the registered medical imaging equipment in China are supplied by foreign manufacturers. In January 2020, the DEEPVESSEL FFR was the first AI medical imaging equipment to be registered in China via the fast-track approval procedure.
Under the influence of China’s strategic policies, the AI medical imaging industry is expected to have a subsequent growth in China, and the outlook remains positive for importing AI software products with its current significant market share.
By Jacky Li. Contact Cisema if you would like to learn more.