SFDA officials: There will be a large number of medical AI listing reviews next year

Medical Network July 3rd 'It is expected that a large number of independent medical Al software will enter the stage of listing review next year. 'Sun Lei, director of the Medical Device Technology Evaluation Center, said on July 2 that the center has not received medical Al products submitted by enterprises. Listing application. However, based on the domestic and international medical AI research and development trends, the Center has set up an Al research working group to study related technical review issues.

The Medical Device Technology Review Center was established in 1996 as the original national food. drug Directly under the supervision and administration of the State Administration (the bureau level), the main function is responsible for the registration of the third category in the territory medical instruments Technical review of imported medical device products, etc.

In recent years, the Center has established a multidisciplinary team of professionals in clinical medicine, clinical diagnosis, biomedical engineering, materials science, and statistics for innovation, priority, major, difficult products, clinical trial approval projects, and the first product of the same variety. The project team review team conducts the review work mechanism, strengthens the professional segmentation review, enhances the professionalization and scientific level of the review, and gradually establishes a clinically oriented, project-based team review system. .

Since the implementation of the special approval process for innovation in 2014, the Center has conducted a technical review of 58 products that entered the special approval channel for innovation. heart Pacemaker, percutaneous interventional artificial heart valve system, vascular reconstruction device, abdominal aortic stent graft system, miR-92a gene expression level detection kit (fluorescent RT-PCR method) and other 34 products were approved and approved for listing. Since the implementation of the priority approval process in January 2017, the Center has conducted a technical review of 15 products entering the priority approval channel, and 5 products including drug-eluting balloon catheters and hollow fiber membrane hemodiafiltration filters have been approved and approved for marketing.

According to Sun Lei, at present, the center has standardized and formed five kinds of consultation and communication systems, covering the application process before registration, the clinical trial application to be approved, the review process, and the whole process of reviewing innovation and priority approval products. . medical instruments enterprise You can communicate with the center through various channels to get business guidance and technical support.