Thanks to policy support, growth in healthcare demand, and improvement in domestic innovation capabilities, China's high-end medical device market has shown momentum of rapid size growth, with the number of medical device products entering the innovative product approval track and obtaining approval continuing to increase. Under the pressure of both centralized procurement and compliance in the medical industry, Chinese medical device enterprises are transforming from extensive to value-oriented development, with continuous increases in R&D investment.
According to Tonghuashun iWencai data, as of June 30, 2025, the top 10 A-share listed medical device enterprises by R&D expenditure are Mindray (RMB 1.607 billion), United Imaging (RMB 766 million), Lepu Medical (RMB 395 million), Yuwell (RMB 295 million), Wantai BioPharm (RMB 276 million), MGI (RMB 272 million), Autobio (RMB 250 million), SonoScape (RMB 244 million), Snibe (RMB 237 million), and Truking Technology (RMB 227 million).
Among the 100 A-share listed medical device enterprises, only Mindray had R&D expenditure exceeding RMB 1 billion. Those with R&D expenditure ratios above 20% included Wantai BioPharm, MGI, SonoScape, Andon Health, Orient Gene Biotech, Lifotronic, and DA An Gene.
Statistics from China Merchants Securities show that in the first half of the year, the overall medical device industry's R&D expenditure ratio was 9.3% (-0.3 pct), sales expense ratio was 16.7% (+0.3 pct), and administrative expense ratio was 8.6% (+0.6 pct).
Overall, constrained by development scale, Chinese enterprises' R&D investment is less than one-fifth of the international level. In the latest Medtech Big 100 for 2025 released by Medical Design & Outsourcing, China only has Mindray Medical and MicroPort listed. China's high-end medical device field remains dominated by foreign brands, with core components such as CT X-ray tubes and superconducting magnets having long relied on imports and the import ratio of key materials remaining high.
As a technology-intensive industry, the medical device industry has high requirements for technological innovation and product R&D capabilities, and relatively long R&D cycles. China's high-end medical device development still faces multiple technical bottlenecks, with insufficient independent innovation in the upstream segment of the industrial chain, leading to high production costs and technology iterations being constrained by others.
To control raw material costs and improve supply chain risk response levels, leading medical device enterprises are continuously increasing R&D investment and accelerating their sprint toward high-end and core fields.
Mindray has established a global innovation exchange and practice platform, with global resources efficiently integrated, and has built an internationally leading Medical Product Innovation system (MPI) and Product Lifecycle Management electronic platform system (PLM). Market-centric and clinical need-oriented, the company ensures the development of correct products needed by the market through demand management, product planning, and portfolio management.
Among them, the technical level of major products and the capabilities of digital-intelligent solutions in the company's Life Information & Support business have gradually entered the global leading ranks, and this business has achieved major breakthroughs in high-end customer groups.
In terms of in vitro diagnostics, Mindray will add at least 15 new chemiluminescence projects annually over the next three years, planning to achieve comprehensive benchmarking of core project competitiveness against international giants in about two years, while significantly reducing reagent costs and beginning a comprehensive high-end breakthrough.
United Imaging has consistently pursued a high-end strategy in medical equipment. Its 3.0T MRI product line's market share in China increased by more than five percentage points year-on-year in the first half of 2025. In July 2025, United Imaging's new-generation uMR Ultra 3.0T MRI system received FDA (510k) clearance for marketing, marking the successful entry of the company's high-end MRI products into the world's strictest and most influential market system.
In the ultrasound field, where no products have yet been launched, United Imaging also pursues the high-end route. The company positions its ultrasound product line as "full-coverage, high-performance, digital-intelligent" clinical ultrasound products and solutions for global healthcare facilities, with full independent controllability. It plans to launch a full line of new ultrasound products in multiple domestic and international market segments, with global market releases expected from the end of this year to early next year.
SonoScape has made an official breakthrough in high-end ultrasound, marked by its launch of the high-end whole-body machine S80 and the high-end obstetrics and gynecology machine P80 in 2024 in the high-end cart-based ultrasound field. Furthermore, SonoScape has initiated investment in Wuhan to build a high-end medical device R&D and manufacturing base.
On the policy front, support for innovative medical devices from the national to local levels is gradually showing full-chain characteristics, covering multiple links including R&D, approval, marketing, regulation, and internationalization.
On July 3, 2025, the National Medical Products Administration of China (NMPA) issued the Announcement on Issuing Measures to Optimize Whole-Life-Cycle Regulation to Support Innovative Development of High-End Medical Devices (Announcement), with a focus on "innovation" as the main line and full-chain support measures to accelerate the innovative transformation of high-end medical devices. The Announcement concentrates on key fields of new quality productive forces such as medical robots, high-end medical imaging equipment, AI-based medical devices, and new biomaterial medical devices, constructing a full-chain support system, covering R&D, approval, post-market regulation, and overseas expansion, through 10 measures.
Specific measures include optimizing special approval procedures, improving classification and naming principles, continuously improving the standard system, further clarifying registration review requirements, improving communication guidance mechanisms and expert consultation mechanisms, refining post-marketing regulation requirements, strengthening post-marketing quality and safety monitoring, closely following industrial development, advancing regulatory science research, and promoting global regulatory coordination.
At the local level, Beijing, Shanghai, Hainan, Guangxi, etc. have successively issued important support measures for high-end medical devices, providing practical preferences from funding to institutional development.
For example, the Action Plan for Promoting the Full-chain Development of the High-end Medical Device Industry in Shanghai proposes the main goal that by 2027, more than 500 new initial registration certificates will be approved for domestic Class III medical devices, more than 100 medical device products will be newly approved in overseas markets, two internationally competitive leading enterprises with annual output value exceeding RMB 10 billion will be cultivated, and three high-end medical device industry clusters will be established.
According to Frost & Sullivan data, from 2020 to 2024, China's overall medical device market size has increased from RMB 729.8 billion to RMB 941.7 billion, with a CAGR of 6.6%, and the size is expected to reach RMB 1,107 billion by 2026.
With ongoing policy guidance from the National Development and Reform Commission, the Ministry of Industry and Information Technology, the NMPA, and other departments, the supply and demand sides are changing. Chinese medical device enterprises are accelerating their march into high-end fields, and the dominance of international giants in the high-end market will continue to be eroded.
Source: Saibailan Devices
01
R&D Expenditures of 100 Listed Device Enterprises Made Public
R&D Expenditures of 100 Listed Device Enterprises Made Public
According to Tonghuashun iWencai data, as of June 30, 2025, the top 10 A-share listed medical device enterprises by R&D expenditure are Mindray (RMB 1.607 billion), United Imaging (RMB 766 million), Lepu Medical (RMB 395 million), Yuwell (RMB 295 million), Wantai BioPharm (RMB 276 million), MGI (RMB 272 million), Autobio (RMB 250 million), SonoScape (RMB 244 million), Snibe (RMB 237 million), and Truking Technology (RMB 227 million).
Statistics from China Merchants Securities show that in the first half of the year, the overall medical device industry's R&D expenditure ratio was 9.3% (-0.3 pct), sales expense ratio was 16.7% (+0.3 pct), and administrative expense ratio was 8.6% (+0.6 pct).
Overall, constrained by development scale, Chinese enterprises' R&D investment is less than one-fifth of the international level. In the latest Medtech Big 100 for 2025 released by Medical Design & Outsourcing, China only has Mindray Medical and MicroPort listed. China's high-end medical device field remains dominated by foreign brands, with core components such as CT X-ray tubes and superconducting magnets having long relied on imports and the import ratio of key materials remaining high.
02
Innovation Support Policies Providing Full-Chain Coverage; Leading Device Companies Collectively Sprinting Toward the High End
Innovation Support Policies Providing Full-Chain Coverage; Leading Device Companies Collectively Sprinting Toward the High End
As a technology-intensive industry, the medical device industry has high requirements for technological innovation and product R&D capabilities, and relatively long R&D cycles. China's high-end medical device development still faces multiple technical bottlenecks, with insufficient independent innovation in the upstream segment of the industrial chain, leading to high production costs and technology iterations being constrained by others.
To control raw material costs and improve supply chain risk response levels, leading medical device enterprises are continuously increasing R&D investment and accelerating their sprint toward high-end and core fields.
Mindray has established a global innovation exchange and practice platform, with global resources efficiently integrated, and has built an internationally leading Medical Product Innovation system (MPI) and Product Lifecycle Management electronic platform system (PLM). Market-centric and clinical need-oriented, the company ensures the development of correct products needed by the market through demand management, product planning, and portfolio management.
Among them, the technical level of major products and the capabilities of digital-intelligent solutions in the company's Life Information & Support business have gradually entered the global leading ranks, and this business has achieved major breakthroughs in high-end customer groups.
In terms of in vitro diagnostics, Mindray will add at least 15 new chemiluminescence projects annually over the next three years, planning to achieve comprehensive benchmarking of core project competitiveness against international giants in about two years, while significantly reducing reagent costs and beginning a comprehensive high-end breakthrough.
United Imaging has consistently pursued a high-end strategy in medical equipment. Its 3.0T MRI product line's market share in China increased by more than five percentage points year-on-year in the first half of 2025. In July 2025, United Imaging's new-generation uMR Ultra 3.0T MRI system received FDA (510k) clearance for marketing, marking the successful entry of the company's high-end MRI products into the world's strictest and most influential market system.
In the ultrasound field, where no products have yet been launched, United Imaging also pursues the high-end route. The company positions its ultrasound product line as "full-coverage, high-performance, digital-intelligent" clinical ultrasound products and solutions for global healthcare facilities, with full independent controllability. It plans to launch a full line of new ultrasound products in multiple domestic and international market segments, with global market releases expected from the end of this year to early next year.
SonoScape has made an official breakthrough in high-end ultrasound, marked by its launch of the high-end whole-body machine S80 and the high-end obstetrics and gynecology machine P80 in 2024 in the high-end cart-based ultrasound field. Furthermore, SonoScape has initiated investment in Wuhan to build a high-end medical device R&D and manufacturing base.
On the policy front, support for innovative medical devices from the national to local levels is gradually showing full-chain characteristics, covering multiple links including R&D, approval, marketing, regulation, and internationalization.
On July 3, 2025, the National Medical Products Administration of China (NMPA) issued the Announcement on Issuing Measures to Optimize Whole-Life-Cycle Regulation to Support Innovative Development of High-End Medical Devices (Announcement), with a focus on "innovation" as the main line and full-chain support measures to accelerate the innovative transformation of high-end medical devices. The Announcement concentrates on key fields of new quality productive forces such as medical robots, high-end medical imaging equipment, AI-based medical devices, and new biomaterial medical devices, constructing a full-chain support system, covering R&D, approval, post-market regulation, and overseas expansion, through 10 measures.
Specific measures include optimizing special approval procedures, improving classification and naming principles, continuously improving the standard system, further clarifying registration review requirements, improving communication guidance mechanisms and expert consultation mechanisms, refining post-marketing regulation requirements, strengthening post-marketing quality and safety monitoring, closely following industrial development, advancing regulatory science research, and promoting global regulatory coordination.
At the local level, Beijing, Shanghai, Hainan, Guangxi, etc. have successively issued important support measures for high-end medical devices, providing practical preferences from funding to institutional development.
For example, the Action Plan for Promoting the Full-chain Development of the High-end Medical Device Industry in Shanghai proposes the main goal that by 2027, more than 500 new initial registration certificates will be approved for domestic Class III medical devices, more than 100 medical device products will be newly approved in overseas markets, two internationally competitive leading enterprises with annual output value exceeding RMB 10 billion will be cultivated, and three high-end medical device industry clusters will be established.
According to Frost & Sullivan data, from 2020 to 2024, China's overall medical device market size has increased from RMB 729.8 billion to RMB 941.7 billion, with a CAGR of 6.6%, and the size is expected to reach RMB 1,107 billion by 2026.
With ongoing policy guidance from the National Development and Reform Commission, the Ministry of Industry and Information Technology, the NMPA, and other departments, the supply and demand sides are changing. Chinese medical device enterprises are accelerating their march into high-end fields, and the dominance of international giants in the high-end market will continue to be eroded.
Source: Saibailan Devices