I. Introduction
As a key part of modern medical technology, innovative medical devices are driving the transformation and upgrading of the healthcare industry. They represent the frontier of medical device technology and play an important role in improving healthcare quality and efficiency and meeting growing public health needs.
In recent years, supported by favorable policies, technological breakthroughs and strong market demand, China’s innovative medical device industry has shown robust growth. The industry is gradually moving from a follower to a peer, and even a leader, in the global medical device market, demonstrating strong market potential and development prospects.
II. Definition and Features of Innovative Medical Devices
1. Definition
Innovative medical devices refer to products that are first developed in China, offer fundamental improvements in performance or safety compared with similar products, reach an internationally leading technical level, and have significant clinical value.
These products usually involve substantial R&D investment and reflect the concentrated achievements of technological innovation in the medical device sector. They can provide new clinical solutions or significantly improve existing treatment outcomes, playing an important role in advancing medical technology and improving patient health.
2. Features
Technological advancement. Innovative medical devices often integrate frontier technologies such as artificial intelligence, big data, biomaterials and microelectronics. This enables them to outperform traditional medical devices in performance, function and safety. For example, AI-based fundus image-assisted diagnosis software can quickly and accurately identify retinal lesions, supporting early diagnosis and precise treatment.
Significant clinical value. These devices address unmet clinical needs and improve treatment outcomes and quality of life. For example, extracorporeal ventricular assist devices provide life support for patients with heart failure, extending the waiting time for heart transplantation and improving survival. Bronchial navigation systems offer new approaches for the diagnosis and treatment of complex lung diseases, reducing surgical risks and improving success rates.
Long R&D cycle and high investment. The full process from R&D, clinical trials and regulatory approval to commercialization in medical institutions usually takes about five to eight years. It requires significant investment in talent, equipment, clinical trials and registration. For example, the development of a high-end surgical robot may require multidisciplinary teams, repeated design improvements, animal studies and clinical trials, with total R&D investment often reaching hundreds of millions of yuan.
Strict approval process. Due to their importance and potential risks, innovative medical devices are subject to strict regulatory review. Applications for special approval must be submitted before product registration and are limited to Class II and Class III medical devices. Class I devices are not eligible. Regulators conduct comprehensive reviews of safety, effectiveness and innovation to ensure compliance with national regulations and standards and protect public safety.
III. Policies Supporting Innovative Medical Devices
Medical devices are a strategic, enabling and high-growth pillar of the modern healthcare system. China attaches great importance to innovation in this sector and views it as an important measure to improve national healthcare capacity and protect public health.
In recent years, regulators have introduced a series of policies to encourage domestic medical device innovation, promote the localization of high-end medical devices, and accelerate the application of new technologies. These policies provide strong support for the rapid development of China’s medical device industry.
1. National Policies
Special Review Procedure for Innovative Medical Devices. This procedure creates a dedicated approval pathway for innovative medical devices, clarifies their definition and review criteria, and provides priority review and approval for qualified products. It significantly shortens time to market and accelerates the commercialization of innovation. High-end devices such as renal artery radiofrequency ablation systems have benefited from this process.
Priority Approval Procedure for Medical Devices. This policy grants priority approval to devices urgently needed in clinical practice, products with clear therapeutic advantages, and devices included in major national science and technology projects or key R&D programs. It supports breakthroughs in key technologies and improves the overall competitiveness of China’s medical device industry.
Supportive policies under the 14th Five-Year Plan. Since the start of the 14th Five-Year Plan period, China has included the medical device industry among strategic emerging industries for priority development. Support measures include industrial planning, funding, tax incentives and industry-academia-research collaboration. These measures help reduce innovation costs, attract social capital and accelerate technology transfer.
2. Local Policies
Provincial and municipal governments have also introduced policies tailored to local industrial conditions. These include faster approval of high-end medical devices, support for R&D of advanced medical equipment, and measures to promote high-quality development of the healthcare industry.
Accelerated approval. Regions with strong medical device industries, such as Beijing, Shanghai and Guangdong, have established green channels for review and approval, improving efficiency and helping innovative products reach the market faster.
R&D support. Local governments provide funding through science and technology programs and industrial guidance funds. They also encourage enterprises to cooperate with universities and research institutions. For example, Jiangsu has offered one-time rewards for projects that enter the national innovative medical device special review process and matching funds for companies undertaking major science and technology projects.
Industrial support. Many local governments support industrial clustering through preferential policies on land, factories and talent. Guangdong, for example, has planned several medical device industrial parks, offering standardized facilities, rent reductions and tax incentives to attract companies and build a stronger industrial ecosystem.
IV. Current Development of the Industry
1. Number of Approved Innovative Medical Devices
China’s medical device innovation has accelerated in recent years, and the number of approved innovative medical devices has continued to rise.
According to the 2025–2030 Research Report on the Current Status and Development Prospects of China’s Innovative Medical Device Market released by the China Business Industry Research Institute, the National Medical Products Administration approved 65 innovative medical devices in 2024. These covered multiple fields, including surgical robots, AI medical devices and cardiopulmonary support systems, and included products such as bronchial navigation systems, fundus image-assisted diagnosis software, extracorporeal ventricular assist devices and renal artery radiofrequency ablation systems.
By the end of 2024, China had approved 315 innovative medical devices. From January to April 2025, another 34 innovative medical devices were approved, reflecting the continued vitality and potential of the market.
2. Domestic and Imported Products
China’s innovative medical device market is mainly driven by domestic products. From 2014 to 2024, among the 315 innovative medical devices approved by the NMPA, 272 were domestic products from 193 companies across 16 provinces, accounting for 86%. Imported products totaled 43, involving 24 companies from six countries, accounting for 14%.
This shows that China’s independent R&D capabilities in innovative medical devices are improving, and domestic enterprises have become the main force in the market. However, further innovation is still needed in some high-end segments to enhance international competitiveness and reduce reliance on imports.
3. Product Structure
By the end of 2024, among approved innovative medical devices, active devices totaled 194, accounting for about 61%; passive devices totaled 97, accounting for 31%; and in vitro diagnostic reagents totaled 24, accounting for 8%.
The relatively high proportion of active and passive devices reflects China’s progress in electronic, intelligent and high-end implantable medical devices. These products play an important role in clinical treatment and provide patients with more advanced therapeutic options.
4. Ranking by Product Category
In 2024, the leading categories of approved innovative medical devices included active surgical instruments, passive implantable devices, active implantable devices, medical software, neurological and vascular surgical instruments, and medical imaging devices, with 23, 10, 6, 5, 4 and 4 approvals, respectively.
Compared with 2023, neurological and vascular surgical instruments and active implantable devices grew rapidly, indicating rising R&D capability and market demand in these high-end fields. Technological innovation in these areas is expected to bring new breakthroughs in disease treatment.
5. Ranking by Province
Approved innovative medical devices are mainly concentrated in economically developed regions and provinces with a strong medical device industrial base. Beijing, Shanghai, Guangdong, Jiangsu and Zhejiang had the highest numbers of approved products and related companies, accounting for about 75.9% of the 315 approved innovative medical devices, though this share declined compared with 2023.
This reflects the clear regional clustering effect of China’s medical device industry. These regions have strong economic capacity, abundant research resources and well-developed industrial supply chains. At the same time, with policy guidance and industrial development, other regions are also emerging, which may lead to a more balanced industrial layout in the future.
6. Key Companies
Although China has a large number of medical device companies, the industry remains relatively fragmented, with low market concentration and significant room for consolidation and scale development.
According to incomplete statistics, by May 2025, more than 200 manufacturers were involved in approved innovative medical devices in China. Some companies have performed particularly well in both the number and quality of approved products and have become core players in the industry.
V. Key Company Case Studies
1. PINS Medical
Beijing PINS Medical Co., Ltd., founded in 2008 and headquartered in Zhongguancun Science Park, Changping Park, Beijing, is a high-tech company specializing in the R&D, production and sales of neuromodulation products, including deep brain stimulators, vagus nerve stimulators, spinal cord stimulators and sacral nerve stimulators.
The company provides advanced treatment solutions for patients with functional neurological diseases such as Parkinson’s disease, epilepsy, pain and urinary incontinence. From 2016 to 2024, PINS Medical had 19 innovative medical device products approved, including implantable rechargeable spinal cord stimulators, implantable spinal cord stimulators, spinal cord stimulation electrodes and extension leads. These products filled several domestic technology gaps, broke long-standing foreign monopolies, and provided more affordable and effective treatment options for Chinese patients.
2. United Imaging Healthcare
Shanghai United Imaging Healthcare Co., Ltd. is a high-tech company providing high-performance medical imaging equipment, radiotherapy products, life science instruments, and digital and intelligent medical solutions worldwide.
The company has maintained strong R&D investment and built a comprehensive product portfolio covering medical imaging, radiotherapy and life science instruments. Its products have reached internationally advanced levels in image quality, scanning speed and intelligence.
In the first quarter of 2025, United Imaging reported revenue of RMB 2.478 billion, up 5.42% year on year, and net profit attributable to shareholders of RMB 370 million, up 1.87%. From 2018 to 2024, the company had nine innovative medical devices approved, including PET/MR systems, medical linear accelerator systems and digital mammography systems. These products strengthened its competitiveness and contributed to the localization of high-end medical imaging equipment in China.
3. Lifetech Scientific
Founded in Shenzhen in 1999, Lifetech Scientific is a national high-tech enterprise and a specialized and sophisticated “Little Giant” enterprise recognized by the Ministry of Industry and Information Technology.
The company focuses on the R&D, production and global expansion of cardiovascular, cerebrovascular and peripheral vascular interventional devices. It has achieved notable progress in high-end interventional products such as aortic stent grafts and left atrial appendage occluders.
In 2024, Lifetech Scientific recorded revenue of RMB 1.304 billion, up 2.9% year on year, and net profit attributable to shareholders of RMB 222 million, down 15.5%. From 2017 to 2025, the company had six innovative medical devices approved, including left atrial appendage occluder systems, implantable cardiac pacemakers, iliac bifurcation stent systems, aortic stent graft fenestration systems, aortic stent graft systems and aortic arch stent systems. These approvals enriched its product portfolio and strengthened its core competitiveness.
4. Huake Precision
Huake Precision Medical Technology (Beijing) Co., Ltd. is an innovative intelligent medical technology company. It has developed more than ten types of products, including medical robots, navigation systems, medical software, medical electrodes and medical lasers.
The company began exploring intelligent medical innovation in 2003. Through independent innovation and industrialization of intracranial electrode technologies, it has achieved more than 90% domestic substitution in this field and supports over 5,000 related surgeries each year, directly advancing functional neurosurgery in China.
From 2018 to 2024, Huake Precision had five innovative medical devices approved, including neurosurgical navigation and positioning systems, MRI-guided semiconductor laser therapy equipment, disposable laser fiber kits and brain surgery planning software. These products improved the precision and safety of neurosurgery and demonstrated the company’s innovation and industrialization capabilities.
5. Mindray Medical
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. is one of China’s leading medical device companies. It is engaged in the R&D, manufacturing, marketing and services of medical devices, providing high-quality products, services and solutions to medical institutions worldwide.
The company’s main products cover three business areas: life information and support, in vitro diagnostics and medical imaging. It has one of the most comprehensive product lines among domestic peers and provides safe, efficient and easy-to-use one-stop products and digital solutions for clinical needs.
In the first quarter of 2025, Mindray reported revenue of RMB 8.237 billion, down 12.12% year on year, and net profit attributable to shareholders of RMB 2.629 billion, down 16.81%. Despite market fluctuations, the company maintained strong profitability and risk resilience. From 2019 to 2024, Mindray had two innovative medical devices approved, including patient monitors and ultrasound diagnostic systems, further strengthening its market position and brand influence.
VI. Development Prospects
1. Stronger Policy Support Creates New Opportunities
Since the start of the 14th Five-Year Plan period, central and local governments have introduced multiple policies to encourage medical device innovation and high-quality industry development.
The NMPA has focused on innovative medical devices and issued the Special Review Procedure for Innovative Medical Devices and the Priority Approval Procedure for Medical Devices, allowing innovative and clinically urgent products to receive faster review and approval. These measures accelerate breakthroughs in core technologies and support the development of high-end medical devices in China.
At the end of 2023, the Ministry of Industry and Information Technology and the National Health Commission jointly held a meeting in Beijing to promote the development and application of medical equipment, emphasizing continued support for medical innovation and the global expansion of high-quality Chinese medical equipment.
At the local level, many provinces and cities have also introduced policies to accelerate approval, support R&D and promote high-quality industrial development. Together, these policies provide a comprehensive and multi-level support system for the innovative medical device industry.
2. Healthcare Reform Expands Market Space
The National Healthcare Security Administration has clarified policies supporting the exemption of innovative medical devices from centralized procurement and their inclusion in medical insurance reimbursement, creating a favorable environment for clinical application and further development.
Exemption from centralized procurement allows innovative devices to maintain relatively reasonable pricing, giving companies more room for profit and encouraging continued R&D investment. Inclusion in medical insurance reduces the financial burden on patients, improves accessibility and supports wider clinical adoption.
To remain competitive, domestic medical device companies are expected to place greater emphasis on innovation, improve product technology and quality, and reduce costs. A reimbursement system that protects reasonable corporate profits will also support R&D investment and create a positive cycle for industry development.
3. Strong Market Demand Provides Broad Growth Space
With global socioeconomic development and changes in population structure, including population aging, rising chronic disease prevalence and growing health awareness, the global innovative medical device market continues to expand rapidly.
China, with one of the world’s largest populations, has enormous and growing demand for innovative medical devices. On one hand, aging is increasing the incidence of age-related diseases such as cardiovascular diseases, neurological disorders and cancer, which require advanced devices for diagnosis and treatment. On the other hand, higher living standards and stronger health awareness are increasing demand for disease prevention, early diagnosis, high-quality care and better treatment outcomes.
In addition, the continued improvement of China’s medical insurance system and the expansion of healthcare services into primary-level markets are creating broader channels for the adoption of innovative medical devices.
4. Rapid Technological Innovation Drives Industry Upgrade
The rapid development of artificial intelligence, big data, cloud computing, biomaterials and gene editing is reshaping the medical device industry toward intelligence, personalization and remote operation.
AI is improving efficiency and accuracy in medical imaging diagnosis, disease risk prediction and surgical robot control. Big data and cloud computing support remote monitoring, data analysis and quality control, enabling intelligent management and maintenance of medical equipment. Advances in biomaterials improve the performance and biocompatibility of implantable devices and expand their applications.
At the same time, Chinese medical device companies are increasing R&D investment and improving innovation capabilities. Breakthroughs have been made in key technologies such as imaging for high-end medical equipment and precision control for minimally invasive interventional devices, accelerating industrialization.
In the future, continued technological innovation will create more growth opportunities and help China move from a major medical device market to a strong medical device power.
VII. Conclusion
Overall, China’s innovative medical device industry is entering a period of rapid development in 2025, driven by policy support, healthcare reform, growing market demand and technological innovation. The market outlook is broad.
Although the industry remains fragmented, ongoing consolidation, scale development and the growth of leading companies are expected to gradually increase market concentration and strengthen competitiveness.
Looking ahead, with continued policy support, ongoing technological innovation and expanding market demand, China’s innovative medical device industry is expected to play a more important role in the global medical device market. It will make greater contributions to improving China’s healthcare capacity and protecting public health, while injecting new vitality into the global medical device industry.
WeChat Official Account |
Video Channel |
