National Medical Products Administration: 76 innovative medical devices were approved for market by 2025, representing a year-on-year increase of 17%.

The reporter learned from the National Medical Device Supervision and Administration Work Conference in 2026 that in 2025, China's medical devices innovation was upgraded and continued to strengthen. Statistics show that in 2025, 76 innovative medical devices were approved for market entry, an increase of 17% compared to the previous year, with a total of 391 approved; 25 medical devices were prioritized for market entry, a 212.5% increase compared to the previous year, with a total of 171 approved. It is understood that in 2025, the National Medical Products Administration accelerated the listing of high-end medical devices through policy integration, issued ten measures to support the innovation and development of high-end medical devices, established a mechanism for the first launch of "global new" medical devices in China, designated a pilot for ultrahigh dose-rate radiation therapy products, and actively cultivated "global new" medical devices made in China. China's real-world research in medical devices is at the forefront globally. The National Medical Products Administration stated that China promotes original innovation and clinical research outcomes transformation in medical devices that are oriented towards clinical value. In 7 provinces and 30 medical institutions, the national medical centers were piloted to include the use of self-developed in vitro diagnostic reagents, with a total of 17 varieties under trial; the publication of the "Catalog of Medical Devices Exempt from Clinical Evaluation" and the "Catalog of In Vitro Diagnostic Reagents Exempt from Clinical Trials"; approval of 8 rare disease diagnostic reagents for precise identification and effective treatment; approval of designated medical institutions in Beijing to import clinically urgently needed products for emergency rescue. The global first launch of the standard material for the Kaposi's sarcoma virus test kit accelerated the approval of the Kaposi's sarcoma virus test kit for market entry; the first approval for the market entry of type A/B influenza virus antigen test kits for personal self-testing, marking a new trend in the use of respiratory disease detection in home settings. In 2025, China made significant progress and breakthroughs in the high-end medical device field: 18 flagship products were approved in the national high-quality development action plan; for the first time, a batch processing method was used to expedite the registration changes of domestically produced core components such as X-ray tubes and high voltage generators; the second batch of artificial intelligence medical devices and innovative tasks for biomedical materials were started with "open competition leadership" work. The reporter learned from the National Medical Products Administration that in 2025, China filled gaps in high-end medical equipment, accelerated the research of key core technologies, and in the next five years, with the deepening development of artificial intelligence, quantum technology, biotechnology, and other fields, China's medical device sector is at a crucial turning point for transitioning from being large to strong and overtaking in lanes. The National Medical Products Administration stated that, while adhering to the primary premise of safety and efficacy, China made significant progress in the research and development of brain-computer interface medical devices, launching two global first standards for brain-computer interface medical devices.