In 2025, China’s medical device industry is entering a new era driven by both tighter regulation and stronger innovation. The revised Good Manufacturing Practice for Medical Devices, implemented by the National Medical Products Administration in November, raises quality-control standards and accelerates review and approval processes. Registrations of innovative medical devices now account for more than 15%, with policy benefits continuing to unfold.
On the technology front, AI-powered diagnostics have achieved a penetration rate of over 40%, while brain-computer interface technologies have completed clinical validation and are expected to move toward commercialization within three years. The market for remote monitoring and intelligent health management has exceeded RMB 80 billion.
On the market side, the localization rate of high-end CT equipment has risen by 28 percentage points compared with 2020, while export value has increased by 19%, led by rapid growth in Southeast Asia and the Middle East. Although expanded volume-based procurement has put pressure on prices of high-value consumables, equipment upgrades and new product launches have helped offset the impact. Leading companies have raised R&D intensity to 12%, with their share prices rebounding by more than 30% year to date. The industry is expected to maintain a compound growth rate of over 10%.
Challenges remain, including rising raw material costs and intensifying international competition, with 30% of small and medium-sized enterprises reporting profit margins below 5%. Looking ahead to 2027, China’s medical device market is expected to exceed RMB 1.5 trillion. Intelligence, globalization, and ecosystem development will become defining themes, as domestic medical devices not only safeguard public health but also emerge as a new engine for China’s high-quality economic growth.
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