People's Daily Health App:

In recent years, the NMPA has strongly encouraged the R&D as well as innovation of medical devices. What progress has been made in the review and approval of innovative medical devices? Thank you.

Li Li:

Thank you for your question. Innovative medical devices are a crucial track in the innovation and R&D of pharmaceuticals. I would like to invite Mr. Lei to answer this question.

Lei Ping:

I will answer this question. The NMPA is fully committed to promoting the R&D and innovation of medical devices, rapidly transforming scientific research achievements into innovative products.

We have collaborated by integrating resources and strengthening inter-ministry cooperation. In partnership with the Ministry of Industry and Information Technology (MIIT), we have organized and implemented a leading project system in the field of innovation. We have selected 48 artificial intelligence (AI) projects and 40 high-end medical device projects in the field of biomaterials, providing them with key support during the application process. We have established three innovation cooperation platforms for AI medical devices, biomaterials and high-end medical equipment, bringing together the strengths of industries, universities, research institutes, hospitals and regulatory authorities.

We have advanced regulatory science research, exploring the application of real-world data, evaluation methods for next-generation gene sequencing products, and other new technological areas. This has led to several new tools, standards and methods, which are now being applied in regulatory work.

We have comprehensively innovated the review mechanism, shifting the focus of medical device technical evaluations to the earlier stages of product R&D. This has accelerated the tackling of key core technologies, helping China achieve significant breakthroughs in high-end medical devices. We have established two medical device evaluation and inspection sub-centers in the Yangtze River Delta and the Greater Bay Area. For provinces with large medical device industries, we have set up service mechanisms to ensure that innovative medical device companies can receive timely professional guidance.

We have identified four key areas for support: AI, novel medical biomaterials, high-end medical imaging, and medical robots. We are working to eliminate bottlenecks and challenges hindering the development of these industries.

We regularly organize regulatory consultations to oversee the nation's first-in-class medical devices and those with complex manufacturing processes. We actively guide and urge enterprises to fully uphold their primary responsibility for quality and safety, ensuring the quality and safety of products.

To date, the NMPA has approved 296 innovative medical devices for market entry, primarily in high-end fields such as implantable interventional devices, advanced imaging, and AI-powered medical devices. Some of these products have reached a leading international position. Examples include: third-generation non-contact ventricular assist devices, which provide effective life support for patients with advanced refractory left-sided heart failure awaiting heart transplants; carbon ion therapy system with independent intellectual property rights in China, which offers a more effective treatment option for certain malignant tumors, having successfully treated over 1,400 patients; advanced deep brain stimulation devices, which have been clinically applied in over 480 hospitals, implanted in 27,000 patients and reached clinical application in eight countries; and innovative PET-CT products, which can image the entire human body with a single scan, offering high resolution scans at low radiation doses. These innovative medical devices not only fill domestic gaps but also significantly reduce the costs of diagnosis and treatment, directly benefiting the public.

Going forward, the NMPA will continue to adhere to a people-centered approach, constantly summarizing experiences and optimizing procedures to launch more high-quality, high-end innovative medical devices. This will ensure that the public truly feels the tangible benefits. Thank you.