Currently, the global medical device industry is undergoing profound changes. As a key milestone in China’s “14th Five-Year Plan” in 2025, the industry is entering a new phase of high-quality development driven by technological innovation, policy initiatives, and market demand.

From a market perspective, intelligence and digitalization are rapidly converging. Technologies such as AI-assisted diagnostics, surgical robots, and the medical Internet of Things (IoMT) are driving the widespread adoption of precision medicine and remote monitoring. An aging population is fueling demand for home medical devices and chronic disease management equipment, while lower-tier markets (markets in third-tier cities, counties, towns, and rural areas) and cross-border e-commerce have emerged as new growth drivers. Simultaneously, domestic substitution is gaining momentum, with breakthroughs in high-end imaging equipment and minimally invasive interventional materials leveraging cost-effectiveness to capture market share.

On the policy front, the State Council’s Opinions on Deepening Reform of Pharmaceutical and Medical Device Regulation emphasizes optimizing review and approval processes, reducing clinical trial periods to 30 days, and prioritizing support for innovative devices such as medical robots and brain-computer interfaces. Additionally, equipment renewal policies are unlocking over 100 billion yuan in funding to upgrade grassroots medical facilities and accelerate the replacement of outdated equipment.

However, the industry also faces challenges, including intensified price competition from centralized procurement, data compliance hurdles in global expansion, and high R&D investment risks driven by rapid technological iterations.

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