China Sees Strong Momentum in Medical Device Innovation and High-End Development

According to information released at the 2026 National Medical Device Supervision and Administration Work Conference, China continued to strengthen innovation and industrial upgrading in the medical device sector in 2025, achieving steady and sustained progress.

Official statistics show that 76 innovative medical devices were approved for market entry in 2025, representing a 17% year-on-year increase, bringing the cumulative total to 391 approvals. In addition, 25 medical devices were approved through priority review and approval, up 212.5% year on year, with a cumulative total of 171 products approved under this pathway.

In 2025, the National Medical Products Administration (NMPA) accelerated the market entry of high-end medical devices through integrated policy measures. Ten targeted measures were introduced to support innovation, alongside the establishment of a “China-first launch” mechanism for globally novel medical devices. Pilot programs were launched for ultra-high-dose-rate radiotherapy products, proactively fostering the development of globally innovative medical devices developed in China. China’s capabilities in real-world evidence research for medical devices are now recognized as being among the world’s leading tier.

The NMPA emphasized continued efforts to promote clinical value–oriented source innovation and the transformation of clinical research outcomes. Key initiatives in 2025 included:

- Pilot programs in 7 provinces and 30 medical institutions allowing national medical centers to independently develop and use in vitro diagnostic (IVD) reagents, with 17 pilot products filed to date.

- Issuance of the Catalogue of Medical Devices Exempted from Clinical Evaluation (2025) and the Catalogue of IVD Reagents Exempted from Clinical Trials (2025).

- Approval of 8 diagnostic reagents for rare diseases, supporting precise diagnosis and effective treatment.

- Authorization for designated medical institutions in Beijing to import urgently needed clinical products for emergency patient care.

- Global first release of reference materials for chikungunya virus testing, accelerating approval of related diagnostic reagents.

- First-time approval of influenza A/B antigen self-test kits for personal use, marking a new era of home-based respiratory disease testing.

Significant breakthroughs were also achieved in the high-end medical device sector in 2025:

- 18 landmark products under the National High-Quality Development Action Plan were approved via priority review.

- For the first time, batch processing was used to accelerate change registration for domestically produced core components such as X-ray tubes and high-voltage generators.

- Launch of the second batch of innovation initiatives for AI medical devices and biomedical materials.

China has continued to address gaps in high-end medical equipment and accelerate breakthroughs in key core technologies. Looking ahead, with the rapid advancement of artificial intelligence, quantum technologies, and biotechnology, China’s medical device industry is entering a critical phase of transition from scale expansion to strength enhancement, presenting opportunities for leapfrog development.

The NMPA also noted that, while maintaining safety and effectiveness as top priorities, major progress has been made in the R&D of brain–computer interface (BCI) medical devices, including the world’s first release of two BCI medical device standards, underscoring China’s growing role in frontier medical technologies.