Premium Medical Device Innovation Results Intensively Materialize, Leading Companies Navigate Industry's New Development Phase

Text | Fu Wen

Editor | Zhang Ju

Currently, the high-end medical device sector offers a favorable cost-performance ratio, especially as the segment of surgical robots gradually gains momentum.

By 2025, China’s medical device innovation ecosystem will be thriving. The latest “2025 Medical Device Registration Work Report” issued by the National Medical Products Administration shows that 76 innovative medical devices were approved for market launch in 2025, a 17% increase year-over-year; 25 products received priority approval, a substantial jump of 212.5% year-over-year.

Among these, approved products broadly cover cutting-edge fields such as medical robots, artificial intelligence, and tumor radiotherapy, with notable breakthroughs in categories like ophthalmic devices, which have transitioned from nonexistence to market presence. These data clearly indicate that under the strong support of review and approval system reforms and precise industrial policies, the medical device industry is entering a golden era of rapid innovation, providing a core investment focus characterized by high technological barriers and high growth potential for the capital market.

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System Breakthroughs:

From “Green Channel” to “Full Lifecycle” Support

The concentrated emergence of medical device innovations in 2025 is no coincidence but results from an increasingly完善, precise, and efficient policy support system. Regulatory approaches have evolved from merely providing a “green channel” for faster approval to a systematic empowerment covering product R&D, clinical trials, approval, and post-market lifecycle management.

Core mechanisms continue to be optimized, with special review and priority approval procedures for innovative medical devices becoming key engines for industry upgrading. The report shows that in 2025, 104 applications entered special review, with 38 receiving priority approval, of which 26 were approved for priority review, significantly improving access and efficiency in fast-track channels.

More notably, the NMPA issued the “Announcement on Optimizing Full Lifecycle Supervision to Support High-End Medical Device Innovation,” integrating policy innovations to remove obstacles in R&D and commercialization of high-end devices. Additionally, a “Global New” medical device first-launch mechanism in China was developed, demonstrating a forward-looking layout to guide China’s innovation to directly participate in global competition.

Support focus is highly concentrated. Policy resources are tilted toward key areas involving national medical system strategies and cutting-edge technology integration. The “2025 Priority Approval Directory for High-End Medical Devices,” focusing on core fields like brain-computer interfaces and surgical robots, clarifies development priorities. Moreover, regulatory authorities have actively mobilized industry-academic-research-medical resources through initiatives like the “Spring Rain Action” pilot and targeted research on brain-computer interfaces and “national key” treatment systems, aiming to meet urgent clinical innovation needs.

Industry support systems are continuously improving. Medical insurance policies and government procurement policies are synergistic. Some regions have included surgical robots and high-end imaging equipment in medical insurance coverage; funds allocated for hospital equipment upgrades favor domestic innovative medical devices, giving priority to local products under equal conditions and opening mainstream hospital markets for domestic high-end devices. Meanwhile, industry standards are being refined, with the NMPA leading the formulation of technical standards and clinical norms for fields like surgical robots and AI medical devices, promoting industry transition from unregulated growth to standardized, high-quality development.

Performance Decoding:

Diverse Growth Validated Under the Innovation Map

Under the strong policy tailwinds, the performance of listed medical device companies is highly correlated with innovation achievements, exhibiting significant features of innovation-driven growth, with further sector differentiation deepening.

Taking a leading high-end imaging equipment company listed on the STAR Market as an example, its new generation high-end CT and MRI products, thanks to breakthroughs in core technology, are accelerating domestic substitution and successfully exporting to many high-end medical centers in Europe and America. According to the company’s earnings report, in Q4 2025, revenue reached 13.821 billion yuan, up 34.18% year-over-year, with net profit attributable to shareholders of 1.888 billion yuan, up 49.6%. The report highlights that the continuous launch of innovative products and increasing market recognition of high-end products are key reasons for improved profitability, confirming the rapid conversion of R&D investments into commercial value.

In precise fields like surgical robots and interventional valves, early movers are turning advantages into sustained performance moats. The company’s earnings report shows that a STAR-listed firm focused on surgical robots saw revenue in Q4 2025 grow 58.38% YoY, with core product installation and per-surgery consumables revenue both experiencing rapid growth. Similarly, companies with proprietary innovative products in neurointervention and electrophysiology also recorded growth rates far exceeding industry averages.

In high-barrier niche fields like electrophysiology and neurointervention, companies with exclusive innovative products demonstrate strong growth certainty. For example, a Shenzhen-based STAR-listed company with a rich product line in electrophysiology and vascular intervention, especially in 3D electrophysiological navigation systems and radiofrequency ablation catheters, continued to expand. According to its earnings report, in Q4 2025, revenue was 2.584 billion yuan, up 25.08% YoY, with net profit also growing rapidly, validating the huge potential of deep innovation in specialized high-value consumables.

Additionally, a STAR-listed company headquartered in Qingdao, a leader in intelligent life sciences instruments, achieved steady growth through technological innovation and global deployment, becoming another benchmark in high-end medical devices. Its 2025 earnings report shows revenue of 2.33 billion yuan, up 2.0% YoY; overseas revenue reached 840 million yuan, up 17.9%, accounting for a record 36% of main business income, up 5 percentage points from 2024.

Particularly, its self-developed Eco-Drive ultra-green technology and fully automated cell culture workstations have become core growth drivers. Revenue from smart medicine, blood technology, and other new industries reached 48.5%, up 8.8% YoY, with AI-related income increasing to 15%, making technological innovation the central engine of performance growth.

Investment Mainline:

Focusing on Frontier Innovation, Domestic Substitution, and Global Expansion

Based on current policy dividends and industry evolution trends, investment opportunities in the medical device sector should revolve around three core themes:

Early adopters of frontier innovation achievements, especially companies with listed products in AI medical devices, brain-computer interfaces, high-end imaging equipment, surgical robots, and new biomaterials that are included in the priority approval catalog and have significant R&D or recently approved products. These fields have high technical barriers, long R&D cycles, and require substantial capital investment. Early approval means enjoying long-term blue ocean market dividends, key to achieving excess returns.

For investors, focus on companies that have achieved core technological breakthroughs in surgical robots and brain-computer interface devices, as well as those with groundbreaking innovative products in AI imaging diagnostics and intelligent life sciences instruments, such as Tianzhi Hang and Haier Bio. These companies, leveraging technological first-mover advantages, will fully benefit from the development dividends of frontier innovation.

Accelerators of high-end domestic substitution, especially in large imaging equipment, endoscopes, cardiac valves, neurointerventional devices, and surgical robots. Domestic leaders in these fields now match international giants in product performance, with clear advantages in cost-effectiveness, supply chain security, and service. Under policies supporting medical insurance cost control and “national brand” promotion, the domestic substitution process is accelerating from grassroots hospitals to top-tier hospitals, continuously expanding market potential.

Investors should focus on leading companies like United Imaging (high-end imaging), Huatai Medical (electrophysiology and vascular intervention), which have mature product systems and extensive clinical deployment, making them core forces in domestic substitution with high certainty of performance growth. Also, watch for companies achieving import substitution breakthroughs in niche segments, which may realize rapid growth due to product scarcity.

Global competitors advancing through international markets, as China’s medical devices shift from trade exports to technological branding. Companies with core technological advantages and international certifications like CE and FDA will face broad global opportunities. Investors are advised to focus on those with established overseas sales channels or strategic partnerships with global giants, especially in licensing-out collaborations, which are key catalysts for valuation revaluation.

For example, Haier Bio, with its global deployment, holds leading market share in multiple countries; MicroPort’s innovative products successfully entered high-end European and American markets; United Imaging’s high-end imaging equipment exports to many countries and regions. These companies successfully integrate Chinese innovation into the global market, offering broader growth space and more internationalized valuation systems.

Future Outlook:

Innovation Long Cycle Begins, Leading High-Quality Development

Looking ahead, with the deep implementation of the “14th Five-Year Plan” for medical equipment industry development and ongoing enhancement of regulatory science, the industry’s long innovation cycle has begun. The positive cycle of policies, capital, talent, and technology will drive the industry from “catch-up” to “leading”, with continuous emergence of high-end medical device innovations, accelerated domestic substitution, faster globalization, and overall high-quality development.

Technologically, the deep integration of frontier technologies such as AI, big data, 5G, and spatial computing with medical devices will be central to industry innovation, promoting products like surgical robots, high-end imaging equipment, and intelligent life sciences instruments toward smarter, more precise, and minimally invasive directions. Applications like AI-assisted diagnosis, intraoperative real-time navigation, and telemedicine will be increasingly implemented, further enhancing clinical value and efficiency. The自主化率 of core technologies will continue to rise, enabling Chinese medical device companies to leap from catch-up to leading positions in more fields.

Market-wise, factors such as aging populations, rising health awareness, and upgraded health demands will sustain growth in high-end medical devices. Policies for hospital equipment upgrades and primary healthcare system construction will further expand market space. Meanwhile, continuous optimization of medical insurance policies and government procurement support will solidify the commercialization of domestic high-end devices, transforming domestic substitution from quantity to quality.

Industry-wise, concentration will keep increasing, with leading companies possessing core innovation, platform capabilities, and global operation strengths capturing larger market shares and leading industry development. The industry-university-research-medical collaborative innovation mechanism will be further refined, with top enterprises deepening cooperation with universities, research institutes, and medical institutions to align R&D with clinical needs and accelerate commercialization. Upstream and downstream supply chain collaboration and domestic replacement of key components will promote the formation of a自主可控、安全高效的产业链体系.

For investors, the beta trend in the medical device sector will gradually give way to profound alpha exploration. The investment logic should return to fundamentals: tracking core R&D pipelines, assessing clinical and commercial value. In the wave of domestic substitution and globalization, identify those truly mastering core technologies, capable of continuously launching major products, and with excellent commercialization platforms.

Given the certainty of aging populations and rising health needs, especially among industry leaders, the medical device sector is undoubtedly a core asset class for navigating economic cycles and sharing the dividends of medical technological progress. In the future, high-end medical device leaders with core innovation, domestic substitution potential, and global competitiveness will occupy a central position in high-quality industry development, generating long-term, stable returns for capital markets.

(This article was published in the March 7 issue of Securities Market Weekly. The author is a senior pharmaceutical researcher at a leading public fund. The stocks mentioned are for illustrative purposes only and do not constitute investment advice.)