The Chinese medical device sector has undergone a transformative decade, evolving from non-existence to establishment and from establishment to excellence, achieving a high rate of domestic production in the mid-to-low-end market. However, high-tech areas such as advanced medical imaging, minimally invasive surgery, and life support, which have significant technical barriers, remained dominated by multinational corporations for a long time. With sustained increases in R&D investment and marked improvements in innovation capabilities among domestic firms, this landscape is now shifting.

For China's medical device industry, 2025 marks a milestone year. Driven by a combination of policy support, technological innovation, and upgraded demand, domestic substitution is no longer confined to the mid-to-low-end market but is making a comprehensive push into the high-end segment. In fields like medical imaging, high-value consumables, and innovative devices, the market share of domestic companies continues to rise, gradually reshaping the industry's competitive structure.

Accelerated Localization of High-End Equipment: Domestic Firms' CT Market Share Tops Multinationals

From a macro perspective, by the end of 2025, the number of domestic medical device manufacturers in China reached 35,758, an increase of 1.51% from 2024, setting a new record. Notably, enterprises capable of producing high-risk Class III devices saw the fastest growth, with a year-on-year increase of approximately 7.83%, significantly outpacing the industry average. This indicates a growing number of domestic companies are now capable of manufacturing sophisticated, high-risk medical equipment.

Product registration data also reflects the pace of industrial upgrading. In 2025, the number of valid registered and filed medical device products nationwide reached 344,316, an 8.80% increase year-on-year. Among these, Class II and Class III products accounted for 37.45% and 8.02% of first-time registrations and filings, respectively, demonstrating the industry's overall trend towards mid-to-high-end products.

Throughout 2025, the National Medical Products Administration approved 76 innovative medical devices, including world-first and China-first products such as photon-counting CT and cardiac nanosecond pulsed field ablation systems. This signifies that China's medical device innovation has transitioned from "following" to "running alongside" global peers, and has even achieved "leading" status in certain areas.

Looking at specific segments, medical imaging equipment is one of the most technologically intensive and capital-intensive sub-sectors within the medical device industry. For a long time, the global high-end medical imaging market was overwhelmingly dominated by three multinational giants: GE Healthcare, Siemens Healthineers, and Philips.

However, data from 2025 shows the competitive landscape has quietly changed. In terms of market share, United Imaging Healthcare led the domestic CT market with a 29.2% share, significantly ahead of other brands. This marks the first time a domestic company has surpassed multinational giants in overall CT market share. GE Healthcare, Neusoft Medical, and Siemens Healthineers followed with shares of 17.4%, 15.7%, and 11%, respectively, ranking second to fourth. The top four brands collectively held over 70% of the market, indicating a high degree of concentration.

The MR market presents a similar picture, with United Imaging Healthcare, Siemens, and GE Healthcare forming the top tier, collectively capturing over 81% of the market share, leveraging advantages in high-field-strength technology and full-industry-chain layout. Chinese companies have successfully entered the top tier of the high-end MR market, which was once completely monopolized by multinationals. Second-tier players like Philips, Neusoft Medical, and Wandong Medical are accelerating their catch-up in niche markets and along domestic substitution pathways.

In the DSA market, Philips, Siemens, and GE Healthcare held 43%, 30%, and 13% of procurement market share in 2025, respectively. Since launching its ceiling-mounted DSA system, United Imaging Healthcare quickly became the top domestic player, breaking the long-term monopoly of multinationals in this field. As domestic companies' technologies continue to mature, the process of import substitution in the DSA market is expected to accelerate further.

The DR market has entered a phase of high maturity, with a domestic substitution rate exceeding 80%. Wandong, Blue Sail Medical, Anjian Technology, United Imaging, and Neusoft Medical ranked as the top five in the DR market, with domestic firms holding an absolute dominant position.

High-End Medical Device Exports Enter Boom Period: PET/CT, Joints See Double-Digit Growth

While achieving breakthroughs in the high-end domestic market, overseas markets have become a second growth engine for Chinese medical device companies. In 2025, despite multiple challenges including rising global trade protectionism, intensified geopolitical competition, and global supply chain restructuring, China's foreign trade in medical devices demonstrated strong industrial resilience in a volatile external environment.

In terms of data performance, the total import and export value for the year reached $85.304 billion, a year-on-year increase of 0.89%, with the trade surplus continuing to expand. Specifically, export value amounted to $50.469 billion, up 3.51% year-on-year, while import value was $34.835 billion, down 2.72% year-on-year.

On the export front, the largest category, diagnostic and therapeutic equipment, performed strongly, with export value reaching $24.057 billion, an 8.12% increase. Surgical/veterinary instrument exports also performed well, reaching $2.863 billion, a 14.89% rise. Particularly noteworthy was the explosive growth in high-end categories: PET/SPECT and surgical robots saw exports double; exports of high-end equipment like endoscopes, joints, MR systems, artificial kidneys, and ventilators all grew at double-digit rates. This indicates that China's medical device exports are gradually shifting from low-value-added products like disposable consumables to technology-intensive high-end products.

In terms of export destinations, the United States remained the largest single market, with total exports reaching $10.493 billion, though this represented a 10.77% year-on-year decline. Exports to the EU and the UK continued their strong performance, growing 8.91% year-on-year, with Germany leading in Europe at $2.800 billion. The emerging market of Latin America performed impressively, with export value reaching $4.486 billion, a 13.29% increase, becoming a key engine for growth. This diversified export structure reduces reliance on any single market and enhances the risk resilience of China's medical device industry.

It is worth noting that the globalization path of Chinese medical device companies has also upgraded, transitioning from simple product exports to a model of "overseas M&A + localized deep cultivation." An increasing number of enterprises are acquiring advanced technologies, brands, and channel resources through overseas mergers and acquisitions, while simultaneously establishing overseas R&D centers, production bases, and sales networks to achieve localized operations. This model not only better meets local market demands but also helps circumvent trade barriers and enhances the international influence of Chinese brands.

For example, Mindray Medical has filled gaps in core technology and global channels by acquiring companies like the US's Datascope and Zonare; it has established 12 overseas R&D centers in global innovation hubs such as Silicon Valley and Seattle in the US and Munich in Germany; it has set up production bases in Mexico, Brazil, India, Russia, and Turkey; and it has built a sales network covering over 190 countries and regions, with a total overseas workforce exceeding 10,000, over 90% of whom are local hires. In 2025, overseas revenue accounted for over 48% of Mindray Medical's total, becoming the company's core growth engine.

Another example is United Imaging Healthcare, which has entered high-end segments by acquiring US proton therapy company Mevion and German endoscopy company EndoTech, and has achieved ecosystem localization through R&D and clinical cooperation in Europe and the US and the construction of a European production base in Ireland. In 2025, its overseas revenue grew over 65% year-on-year, with exports of high-end CT and MR systems doubling.

On the import side, influenced by multiple factors including industrial upgrading, policy guidance, demand optimization, and supply chain adjustments, the total import volume declined, with a coexistence of substitution effects and rigid demand for high-end products. The total import value for the year fell 2.72% year-on-year, a moderate overall decrease. Affected by centralized procurement policies and breakthroughs in domestic technology, imports of mid-to-high-end categories such as in-vitro diagnostic reagents, artificial joints, MR systems, and X-ray equipment saw double-digit declines. Meanwhile, products with extremely high technical barriers, such as high-end CT scanners, high-end color ultrasound systems, and ophthalmic diagnostic and therapeutic equipment, maintained growth, indicating that import demand is accelerating its focus on these specific areas.

In terms of import sources, they have become more diversified. Traditional major sources like the United States, Germany, and Japan saw their import values decline by 11.15%, 6.11%, and 5.75% year-on-year, respectively, impacted by domestic substitution. Benefiting from active entrepot trade and deepening bilateral medical technology cooperation, imports from Singapore reached $1.194 billion, a 38.91% increase. Mexico achieved steady growth through supply chain synergy and optimized trade routes, with import value reaching $2.629 billion, up 7.89% year-on-year. Markets like the UK and France also maintained stable growth.

Despite the significant achievements in import substitution in 2025, China's medical device industry still faces numerous challenges. In core component areas, such as detectors, magnets, and X-ray tubes for high-end medical imaging equipment, some reliance on imports remains, and the level of autonomy and control over the industrial and supply chains needs further improvement.

In terms of basic research and original innovation, domestic manufacturers still lag behind international top-tier levels, with relatively few truly original technologies and products capable of leading global industry development. Furthermore, with the normalization and deepening of centralized procurement policies, corporate profit margins are being further compressed. How to ensure product quality and maintain R&D investment while reducing prices is a challenge all companies must confront.