In 2025, the National Medical Products Administration (NMPA) approved a total of 76 domestic innovative medical devices for marketing, maintaining a high volume for three consecutive years. These devices cover multiple cutting-edge fields including artificial intelligence, tumor radiotherapy, and biomedical materials.

The data released by the NMPA on January 6 clearly outlines the transformation landscape of China's high-end medical device industry.

From once relying on imports for high-end diagnostic and therapeutic equipment to the current batch emergence of "China Smart Manufacturing", from being a supplementary clinical option to becoming a core treatment device, and from following and imitating technologies to leading original innovation—driven by the combined effects of targeted policy support, continuous technological breakthroughs, and market demand traction—China's high-end medical device industry is undergoing a remarkable transformation from low-level redundancy to innovation-driven quality improvement.

"Previously, most cardiac surgeries relied on imported radiofrequency ablation devices, but now domestic pulsed electric field ablation systems not only have fewer side effects but also deliver better therapeutic outcomes," said Mr. Wang, a patient who had just undergone atrial fibrillation ablation therapy in the ward of a top-tier Grade A hospital in Beijing. The innovative device that benefited him is an independently developed high-end domestic medical instrument, which is now emerging as a mainstay in clinical treatment.

The innovative breakthrough of high-end domestic medical devices is underpinned by dual supports: institutional innovation and regulatory empowerment.

In recent years, the NMPA has continuously deepened the reform of the medical device review and approval system, establishing a diversified channel system including special review for innovative products and priority approval. It has shifted the focus of regulatory services to the R&D phase, forming a working mechanism featuring "early intervention, enterprise-specific policies, full-process guidance, and collaborative R&D-review interaction", thus smoothing the path to market for innovative products.

"The core of the reform is to unleash the vitality of innovation and safeguard product quality," stated Lyu Ling, Director General of the Medical Device Registration Department of the NMPA. Through key measures such as optimizing the special approval procedures, improving classification and naming principles, and enhancing communication and guidance mechanisms, the authority has provided targeted support for high-end medical devices including artificial intelligence products, medical robots, and new biomaterials. In December 2025, it further issued a Priority Approval Catalog for High-end Medical Devices focusing on core fields such as brain-computer interfaces and high-end imaging equipment, accelerating the clinical application of urgently needed products. Today, the efficiency of review and approval for innovative medical devices has been continuously improved, with the cycle from R&D to market launch significantly shortened, which has greatly stimulated the innovation vitality of enterprises.

The continuous release of policy dividends has driven the industry to achieve breakthroughs in various fields, with original innovation capabilities and product quality improving in tandem.

The year 2025 marked a bumper harvest for domestic high-end medical devices:

• In April, the Transcatheter Aortic Valve System developed by Jins Bio-tech (Changshu) Co., Ltd. obtained marketing approval. While enhancing the convenience of clinical use, it reduces the risk of leaflet deformation caused by long-term compression of the valve leaflets.

• In June, the Spinal Surgery Navigation and Positioning Device launched by Sino-European Zhiwei Co., Ltd. hit the market, pioneering the application of micro-manipulator technology in the orthopedic field.

• In August, photon-counting CT scanners independently developed by Neusoft Medical Systems Co., Ltd. and United Imaging Healthcare Co., Ltd. received approval successively, achieving a technological breakthrough in the field of CT imaging.

• In September, the Cross-linked Polyisobutylene Aspherical Intraocular Lens developed by Xi'an Eyedole Medical Technology Co., Ltd. was approved for marketing. Adopting domestically produced raw materials with independent intellectual property rights, the product features low oxidation and hydrolysis risks.

Lyu Ling noted that Chinese enterprises have continuously made breakthroughs in core technologies; some products have not only broken the import monopoly but also surpassed international counterparts in technical indicators, becoming reliable choices for clinical diagnosis and treatment.

The synergistic efforts of regulatory optimization and market mechanisms have accelerated the clinical translation of high-end medical devices, benefiting the general public.

On the one hand, the improvement of the medical security system and the innovation of procurement mechanisms have effectively reduced equipment procurement and usage costs through centralized procurement and medical insurance negotiations, enabling once expensive high-end equipment to gradually enter primary hospitals. On the other hand, regulatory authorities have strengthened the whole-life-cycle quality and safety management, building a solid line of defense for quality and safety through regular sampling inspections of key product categories and full-coverage supervision and inspection of manufacturing enterprises.

Data from the NMPA confirms the rapid development of the industry: since the launch of the 14th Five-Year Plan period, China has approved 292 innovative medical devices, which is 3.3 times the number approved during the 13th Five-Year Plan period. In 2025, a total of 139 national and industry standards were formulated, revised, and issued in the medical device field, including the country's first standard for brain-computer interface medical devices, laying a solid institutional foundation for industrial innovation.

While consolidating the domestic market, high-end domestic medical devices are accelerating their integration into the global medical industry landscape.

In 2024, China's medical device export volume accounted for approximately 8% of the global market, ranking 4th worldwide. Chinese enterprises are not only expanding overseas markets through authorized cooperation but also actively establishing R&D centers and production bases abroad to directly serve global patients.

On international platforms such as the International Medical Device Regulators Forum (IMDRF) and the Global Harmonization Working Party on Medical Devices (GHWP), the voice of Chinese enterprises is becoming increasingly prominent. Ninety percent of IMDRF technical documents have been adopted and implemented in China. The international alignment of China's regulatory system has paved the way for product exports and enhanced the international recognition of Chinese standards.

Standing at the historical starting point of the 15th Five-Year Plan period, high-end domestic medical devices are steadily advancing along the path of "core technology breakthroughs—in-depth clinical integration—improved industrial ecology—global layout expansion". With better therapeutic effects, higher quality, and more affordable prices, they are bringing hope to patients in China and around the world.

Source: Xinhua News Agency