Sino-Singapore Health – State Food and Drug Administration- 296 innovative medical devices have been approved for marketing
On September 13, Lei Ping, the Deputy Director of the National Medical Products Administration (NMPA), announced significant strides in the approval of innovative medical devices, with 296 products approved for market release. These devices predominantly focus on advanced areas such as implantable technology, high-end imaging, and artificial intelligence, with some achieving international prominence.
During a press conference held by the State Council Information Office under the theme “Promoting High-Quality Development,” a reporter asked about the latest progress in the evaluation and approval process for these innovative medical devices.
In his response, Lei emphasized the NMPA’s dedicated efforts to enhance research and development in the medical device sector, aiming to transform scientific research into market-ready innovations. He pointed out that through better resource integration and improved inter-departmental collaboration, the NMPA, in partnership with the Ministry of Industry and Information Technology, has launched a competitive selection process in innovative domains. This initiative has successfully identified 48 artificial intelligence projects and 40 biomaterials projects for advanced medical devices, which will now receive focused support during their application phases. Additionally, three collaboration platforms have been established to bring together stakeholders from industry, academia, and healthcare, specifically targeting AI medical devices, biomaterials, and high-end medical equipment.
Lei further highlighted ongoing research in regulatory science, exploring cutting-edge technologies including the use of real-world data and evaluation methods for next-generation gene sequencing products. These initiatives have led to the development of new tools, standards, and methods now incorporated into regulatory processes.
Moreover, a comprehensive innovation review mechanism has been introduced, shifting the focus of medical device assessments to earlier stages in product development. This strategy is designed to expedite breakthroughs in essential core technologies, particularly for high-end medical devices. The NMPA has set up two evaluation centers in the Yangtze River Delta and the Greater Bay Area to create service mechanisms that provide timely expert guidance to innovative companies in major medical device-producing provinces.
Recognizing the need to tackle specific industry challenges, the NMPA has also identified four priority support areas: artificial intelligence, novel medical biomaterials, advanced medical imaging, and medical robotics.
The agency conducts regular regulatory consultations to monitor the rollout of innovative medical devices and those with complex production processes, actively guiding companies to meet quality and safety standards and ensuring high product quality.
Currently, Liu noted that the agency has approved a total of 296 innovative medical devices. These primarily include implantable technologies, high-end imaging systems, and AI-driven medical equipment, with several products gaining international acclaim. For example, the third-generation non-contact magnetic levitation artificial heart provides vital life support for patients with difficult-to-treat advanced left heart failure, prior to heart transplantation. Additionally, the domestically developed carbon ion treatment system offers a more effective therapy for certain malignant tumors, having successfully treated over 1,400 patients. The advanced brain pacemaker has been clinically used in over 480 hospitals, benefiting 27,000 patients across eight countries. An innovative PET-CT product, capable of whole-body organ scans with high resolution and low radiation exposure, also stands out in this lineup. These groundbreaking devices not only bridge domestic gaps but also significantly lower diagnosis and treatment costs, ultimately serving the public good.
