The National Medical Products Administration (NMPA) in China has been improving the approval system to promote the development of medical artificial intelligence solutions. China has published relevant documents including classification catalogs and approval procedures regarding the registration and approval of medical AI products.

New NMPA Regulatory Documentation

On Aug. 1, 2018, the new version of the Medical Device Classification Catalogue came into effect, clarifying the classification criteria for medical AI products for the first time. In July 2019, the Medical Device Technology Evaluation Center of the Chinese Food and Drug Administration officially released the Deep Learning-assisted Decision-Making Medical Device Software Approval Essentials, which covers the scope of application, key points of approval, software updates, relevant technical considerations, and description of registration and application materials. The document further clarifies the details for product approval, stating that the clinical evaluation of products can use retrospective research based on existing historical data.

Recent Medical AI Breakthroughs

In 2020, the NMPA has ushered major breakthroughs in the approval of medical AI solutions.

Keya Medical’s product, DEEPVESSEL FFR, was the first Class III Medical Device in China to receive regulatory approval from the NMPA. DEEPVESSEL FFR uses deep learning to perform a non-invasive physiological functional assessment of the coronary arteries using coronary computed tomography angiography (CCTA) scans. One month after obtaining the regulatory certification from the NMPA, Keya Medical received a round of strategic financing. This financing round was considered a key breakthrough in China for the medical AI industry. The approval of the first Class III medical device in China may accelerate further AI development.

During the COVID-19 pandemic, a series of medical AI products used for diagnosis have greatly improved the diagnosis and treatment of patients suspected with COVID-19 pneumonia in China. There are currently more than 140 companies developing medical AI products across China, of which more than 20 have demonstrated promising potential in diagnosing COVID-19 pneumonia. The high performance of medical AI solutions during the COVID-19 pandemic has helped to confirm the value AI can bring to healthcare.

Accelerating AI Product Development

Keya Medical has now completed the development of more comprehensive medical AI products and will continue to develop technologies that meet real clinical needs across healthcare. With the continued development of regulatory policies and the advancements in regulatory requirements, AI solutions will soon be able to benefit patients and caregivers worldwide.