In 2025, the National Medical Products Administration (NMPA) approved the marketing of a total of 76 domestically developed innovative medical devices. The number has remained at a high level for three consecutive years, covering multiple cutting-edge fields, such as artificial intelligence, tumor radiotherapy, and biomedical materials.
This set of data released by the NMPA on January 6 clearly outlines the transformation landscape of China's high-end medical device industry.
From the past reliance on imports for high-end diagnostic and treatment equipment to today's emergence of large numbers of "Intelligently Made in China" products, from being supplemental options in clinical practice to growing into core therapeutic equipment, from following and imitating technology to moving toward leading source innovation, China's high-end medical device industry is undergoing a transformation from low-level repetitive competition to innovation-driven quality improvement under the combined action of precise policy empowerment, sustained technological breakthroughs, and strong market demand.
"In the past, most cardiac surgeries relied on imported radiofrequency ablation equipment. Now, domestically-made pulsed field ablation (PFA) generators not only have fewer side effects but also excellent effects, " said Mr. Wang, who had just received atrial fibrillation ablation treatment, in the ward of a Grade A tertiary hospital in Beijing. The innovative device that treated him is a high-end medical device independently developed in China, which is becoming a mainstay of clinical treatment.
Behind the breakthrough of Chinese-developed high-end medical devices via innovation is the dual backing of institutional innovation and regulatory empowerment.
In recent years, the NMPA has continued to deepen the reform of the review and approval system, with diverse pathways, such as the special review procedures for innovative medical devices and priority review and approval, established. It has advanced the focus of regulatory services forward to the R&D stage and formed a working mechanism of "early involvement, enterprise-specific policies, whole-process guidance, and linkage between research and review," making the path to market smoother for innovative products.
"The core of the reform is to remove constraints on innovation while safeguarding quality, " said Lyu Ling, Director-General of the Department of Medical Device Registration, NMPA. The NMPA has provided focused support for high-end medical devices in areas such as artificial intelligence, medical robots, and new biomaterials, by optimizing special approval procedures, improving classification and naming principles, and establishing sound communication and guidance mechanisms, among other key measures. In December 2025, the NMPA further released a catalog of high-end medical devices eligible for priority approval with a focus on core areas such as brain-computer interfaces and high-end imaging equipment, to accelerate the fruition of urgently needed clinical products. Today, the efficiency of review and approval for innovative medical devices continues to improve, and the cycle from R&D to market has been significantly shortened, greatly stimulating the innovative vitality of enterprises.
The continued release of policy benefits has driven breakthroughs in multiple fields of the industry, simultaneously improving source innovation capabilities and product quality.
The year 2025 became a bumper year for Chinese-developed high-end medical devices:
In April, the transcatheter aortic valve system from Kingstronbio (Changshu) Co., Ltd. was approved. The system reduces the risk of leaflet deformation caused by long-term compression while enhancing clinical use convenience;
In June, Sino-Euro MicroRobotics' spinal surgery navigation and positioning equipment was marketed, taking the lead in introducing miniature robotic arm technology into the orthopedics field;
In August, photon-counting CT products from Neusoft and United Imaging Healthcare were successively approved, making new technological breakthroughs in the field of CT imaging;
In September, the cross-linked polyisobutylene (xPIB) aspheric intraocular lens (IOL) from Xi'an Eyedeal Medical Technology Co., Ltd. was approved. The product utilizes domestically produced raw materials with independent intellectual property rights, presenting a low risk of oxidation and hydrolysis...
Lyu Ling stated that Chinese enterprises are making breakthroughs in core technologies. Some products have not only broken up imported products' monopolies but have also caught up in technical indicators, becoming reliable choices for clinical diagnosis and treatment.
The synergy of regulatory optimization and market mechanisms has accelerated the clinical adoption of high-end medical devices to benefit people.
On the one hand, the improvement of the medical security system and innovations in procurement mechanisms, such as centralized procurement and National Reimbursement Drug List (NRDL) price negotiations, have effectively reduced equipment procurement and usage costs, enabling high-end equipment that was once expensive to be gradually adopted by grassroots hospitals; on the other hand, regulators have strengthened lifecycle quality and safety management, with a solid defense line built for quality and safety through regular sampling inspections of key varieties and full-coverage supervision and inspections of manufacturers.
The rapid development of the industry is corroborated by NMPA data: China has approved 292 innovative medical devices since the start of the 14th Five-Year Plan, which is 3.3 times the number during the 13th Five-Year Plan period. In 2025, 139 national and industry standards in the medical device field were formulated/revised and released, and the first medical device standard for brain-computer interfaces was released, laying a solid institutional foundation for industrial innovation.
Chinese-developed high-end medical devices, while developing the domestic market, are also accelerating their integration into the global healthcare industry landscape.
In 2024, China's medical device exports accounted for about 8% of the global market, ranking fourth in the world. Chinese enterprises not only expand overseas markets through licensing cooperation, but also actively establish R&D centers and production bases overseas to directly serve global patients.
The voice of Chinese enterprises is growing louder on platforms, such as the International Medical Device Regulators Forum (IMDRF) and the Global Harmonization Working Party (GHWP). Ninety percent of IMDRF technical documents have been transformed and implemented in China. The regulatory system's alignment with international standards paves the way for products to go global and enables Chinese standards to gain more international recognition.
Standing at the historical node of the opening of the 15th Five-Year Plan, Chinese-developed high-end medical devices are steadily advancing along the path of "core technology breakthroughs - deep clinical integration - industrial ecosystem improvement - global expansion," bringing hope to patients in China and around the world with better efficacy, higher quality, and more affordable prices.
Source: Xinhua News Agency
This set of data released by the NMPA on January 6 clearly outlines the transformation landscape of China's high-end medical device industry.
From the past reliance on imports for high-end diagnostic and treatment equipment to today's emergence of large numbers of "Intelligently Made in China" products, from being supplemental options in clinical practice to growing into core therapeutic equipment, from following and imitating technology to moving toward leading source innovation, China's high-end medical device industry is undergoing a transformation from low-level repetitive competition to innovation-driven quality improvement under the combined action of precise policy empowerment, sustained technological breakthroughs, and strong market demand.
"In the past, most cardiac surgeries relied on imported radiofrequency ablation equipment. Now, domestically-made pulsed field ablation (PFA) generators not only have fewer side effects but also excellent effects, " said Mr. Wang, who had just received atrial fibrillation ablation treatment, in the ward of a Grade A tertiary hospital in Beijing. The innovative device that treated him is a high-end medical device independently developed in China, which is becoming a mainstay of clinical treatment.
Behind the breakthrough of Chinese-developed high-end medical devices via innovation is the dual backing of institutional innovation and regulatory empowerment.
In recent years, the NMPA has continued to deepen the reform of the review and approval system, with diverse pathways, such as the special review procedures for innovative medical devices and priority review and approval, established. It has advanced the focus of regulatory services forward to the R&D stage and formed a working mechanism of "early involvement, enterprise-specific policies, whole-process guidance, and linkage between research and review," making the path to market smoother for innovative products.
"The core of the reform is to remove constraints on innovation while safeguarding quality, " said Lyu Ling, Director-General of the Department of Medical Device Registration, NMPA. The NMPA has provided focused support for high-end medical devices in areas such as artificial intelligence, medical robots, and new biomaterials, by optimizing special approval procedures, improving classification and naming principles, and establishing sound communication and guidance mechanisms, among other key measures. In December 2025, the NMPA further released a catalog of high-end medical devices eligible for priority approval with a focus on core areas such as brain-computer interfaces and high-end imaging equipment, to accelerate the fruition of urgently needed clinical products. Today, the efficiency of review and approval for innovative medical devices continues to improve, and the cycle from R&D to market has been significantly shortened, greatly stimulating the innovative vitality of enterprises.
The continued release of policy benefits has driven breakthroughs in multiple fields of the industry, simultaneously improving source innovation capabilities and product quality.
The year 2025 became a bumper year for Chinese-developed high-end medical devices:
In April, the transcatheter aortic valve system from Kingstronbio (Changshu) Co., Ltd. was approved. The system reduces the risk of leaflet deformation caused by long-term compression while enhancing clinical use convenience;
In June, Sino-Euro MicroRobotics' spinal surgery navigation and positioning equipment was marketed, taking the lead in introducing miniature robotic arm technology into the orthopedics field;
In August, photon-counting CT products from Neusoft and United Imaging Healthcare were successively approved, making new technological breakthroughs in the field of CT imaging;
In September, the cross-linked polyisobutylene (xPIB) aspheric intraocular lens (IOL) from Xi'an Eyedeal Medical Technology Co., Ltd. was approved. The product utilizes domestically produced raw materials with independent intellectual property rights, presenting a low risk of oxidation and hydrolysis...
Lyu Ling stated that Chinese enterprises are making breakthroughs in core technologies. Some products have not only broken up imported products' monopolies but have also caught up in technical indicators, becoming reliable choices for clinical diagnosis and treatment.
The synergy of regulatory optimization and market mechanisms has accelerated the clinical adoption of high-end medical devices to benefit people.
On the one hand, the improvement of the medical security system and innovations in procurement mechanisms, such as centralized procurement and National Reimbursement Drug List (NRDL) price negotiations, have effectively reduced equipment procurement and usage costs, enabling high-end equipment that was once expensive to be gradually adopted by grassroots hospitals; on the other hand, regulators have strengthened lifecycle quality and safety management, with a solid defense line built for quality and safety through regular sampling inspections of key varieties and full-coverage supervision and inspections of manufacturers.
The rapid development of the industry is corroborated by NMPA data: China has approved 292 innovative medical devices since the start of the 14th Five-Year Plan, which is 3.3 times the number during the 13th Five-Year Plan period. In 2025, 139 national and industry standards in the medical device field were formulated/revised and released, and the first medical device standard for brain-computer interfaces was released, laying a solid institutional foundation for industrial innovation.
Chinese-developed high-end medical devices, while developing the domestic market, are also accelerating their integration into the global healthcare industry landscape.
In 2024, China's medical device exports accounted for about 8% of the global market, ranking fourth in the world. Chinese enterprises not only expand overseas markets through licensing cooperation, but also actively establish R&D centers and production bases overseas to directly serve global patients.
The voice of Chinese enterprises is growing louder on platforms, such as the International Medical Device Regulators Forum (IMDRF) and the Global Harmonization Working Party (GHWP). Ninety percent of IMDRF technical documents have been transformed and implemented in China. The regulatory system's alignment with international standards paves the way for products to go global and enables Chinese standards to gain more international recognition.
Standing at the historical node of the opening of the 15th Five-Year Plan, Chinese-developed high-end medical devices are steadily advancing along the path of "core technology breakthroughs - deep clinical integration - industrial ecosystem improvement - global expansion," bringing hope to patients in China and around the world with better efficacy, higher quality, and more affordable prices.
Source: Xinhua News Agency