At present, my country's medical device industry is in a critical window period of transformation from low-end and mid-end to high-end. There is an urgent need to optimize and transform the industrial structure. The country has issued major favorable policies for medical devices, and the development of the high-end medical device industry has ushered in new opportunities.
The National Medical Products Administration released ten major measures
01 Good news for four high-end equipment fields
On July 3, the National Medical Products Administration officially announced the "Announcement of the National Medical Products Administration on the Issuance of Measures to Optimize Full Life Cycle Supervision and Support the Innovation and Development of High-end Medical Devices (No. 63 of 2025)" (hereinafter referred to as the "Announcement"), fully supporting major innovations in high-end medical devices.
The announcement clearly positions high-end medical devices as a key area for shaping new quality productivity of medical devices, covering four major areas: medical robots, high-end medical imaging equipment, artificial intelligence medical devices and new biomaterial medical devices.
The ten major measures proposed in the announcement include: optimizing special approval procedures, improving classification and naming principles, continuously improving the standard system, further clarifying registration review requirements, improving communication and guidance mechanisms and expert consultation mechanisms, refining post-marketing regulatory requirements, strengthening post-marketing quality and safety monitoring, closely following industrial development, advancing regulatory science research, and promoting global regulatory coordination.
According to the forecast of the Forward-looking Research Institute, by 2030, the global high-end medical device market size is expected to exceed 1.8 trillion US dollars, and the Chinese high-end medical device market size is expected to reach 2.8 trillion yuan.
As of June 27, 2025, my country has approved 360 innovative medical devices, 44 more than in 2024. Driven by both policies and the market, my country's medical device industry is showing a trend of innovation, digitalization, localization, greening, and internationalization.
According to the announcement, my country will establish a faster and more updated review and approval mechanism for high-end medical devices. The announcement proposes continuing to implement special innovation reviews for high-end medical devices that meet the requirements and are domestically pioneering, internationally leading, and have significant clinical application value. The announcement also proposes further optimizing the innovation review process, strengthening communication between applicants and review experts, and strengthening technical guidance for the development and registration of innovative medical devices.
Registration changes for high-end innovative medical devices will be reviewed in accordance with the special innovation review procedure. Support will be provided to accelerate the launch of high-end medical devices included in national-level high-quality development action plans and other industrial policies.
Notably, the document specifically outlines support requirements for the brain-computer interface (BCI) sector. The announcement calls for strengthening registration guidance for AI and biomaterials products, and for coordinating with relevant departments to introduce support policies for medical devices based on BCI technology.
In terms of establishing a standards system, we require further improvement of the high-end medical device standards system. We should expedite the release of standards for medical exoskeleton robots and radionuclide imaging equipment. We should accelerate the development and revision of basic, general, and methodological standards for medical robots, artificial intelligence medical devices, and high-end medical imaging equipment, and actively prepare for the establishment of technical organizations for the standardization of medical robots and artificial intelligence medical devices.
Strengthen standardization research on new biomaterials, including medical materials for additive manufacturing, flexible electrodes for brain-computer interfaces, and genetically engineered biomaterials. Conduct research on standard datasets for artificial intelligence medical devices. Based on industry development and regulatory needs, promote the establishment of urgently needed standards for high-end medical devices through a fast-track process.
02 Strengthen post-market supervision, quality and safety monitoring, medical surgical robots, and artificial intelligence medical devices
my country's high-end medical devices are rapidly developing, with domestic substitution rates increasing. However, many supporting measures lag behind technological development, including outdated standards systems, a mismatch between review resources and demand, rigid clinical evaluation requirements, and insufficient international mutual recognition. Given the high unit prices of high-end medical devices, post-market supervision and quality testing require more rigorous, scientific, and targeted supporting measures.
This announcement emphasizes refining post-market regulatory requirements, strengthening post-market quality and safety monitoring, and promoting global regulatory coordination.
The government will select representative innovative medical devices, such as those pioneered domestically, for regulatory consultations. It will also guide provinces with concentrated innovative medical device production to conduct local regulatory consultations, analyze innovations and risks, and develop targeted regulatory measures. The government will also accelerate the development of key quality management system inspection points for innovative products such as carbon ion/proton therapy systems, animal-derived artificial heart valves, metal additive manufacturing bone implants, and polyetheretherketone (PEEK) wire anchors, as well as high-end products such as medical surgical robots, artificial intelligence medical devices, and recombinant collagen.
Strengthen the selection and training of national inspectors, and cultivate a group of national inspectors for high-end medical devices; carry out quality management system verification work for provincial inspection agencies, strengthen the capacity building of provincial inspection agencies, and improve the quality and efficiency of inspections.
In terms of post-market quality and safety monitoring, research will be conducted on the management requirements for the lifespan of currently used high-end active medical devices. Medical device users will be urged to regularly inspect and maintain medical devices such as surgical robots, rehabilitation robots, and high-end medical imaging equipment to ensure quality in clinical use. Medical device registrants will be supported in conducting post-market evidence-based research. The types of adverse events associated with medical devices such as high-end medical imaging equipment and artificial intelligence medical devices will be refined, and corresponding reporting scope specifications will be developed to improve the quality of adverse event reporting.
We will continue to promote the new active monitoring project of the Global Council for Harmonization of Medical Devices (GHWP), taking high-risk cardiovascular implantable medical devices as the starting point, explore the basic framework and related database construction methods for active monitoring of medical devices after they are marketed, and guide registrants to use new tools and methods for medical device vigilance to carry out signal mining and utilization of adverse event monitoring data.
Guide registrants to proactively conduct post-market evaluations to continuously improve product safety and reliability. Guide local governments to strengthen the construction of high-end medical device inspection and monitoring teams and enhance their inspection and monitoring capabilities for high-end medical devices.
