China's 2025 Two Sessions Highlight Medical Device Innovation and Market Access Trends

During the 2025 "Two Sessions," China’s annual legislative and political advisory meetings that concluded on March 11, 2025, the medical device sector was identified as a key priority, as reported by the China Associate for Medical Devices Industry (CAMDI). Representatives from academia, healthcare, industry, and research submitted coordinated recommendations focused on high-end innovation, equipment upgrades, technology adoption, and centralized procurement challenges. These developments, effective from 2025, carry strategic implications for international manufacturers seeking to access or expand in China’s regulated healthcare market.

Overview of China’s 2024 Medical Device Approvals: Accelerated Innovation and Refined Classification

In 2024, the National Medical Products Administration (NMPA) approved medical devices categorized by risk level as follows:

• Class I (Low Risk): Basic surgical instruments, accounting for approximately 59% (11,170 units approved in the first half of 2024);
• Class II (Medium Risk): Diagnostic equipment, representing 33.7% (6,382 units approved);
• Class III (High Risk): Implantable devices such as cardiac pacemakers, comprising 7.3% (1,382 units approved).

Notably, 2024 saw a record-breaking 65 innovative medical devices approved, with domestic products accounting for 71%, highlighting the rapid advancement of local R&D capabilities. However, imported devices continue to dominate high-value segments, such as imaging systems and cardiovascular interventional products. Among the 572 imported devices approved in the first half of 2024, 40% fell under Class III.

Implications for Overseas Manufacturers: Demand for high-risk, high-tech medical devices in China continues to grow, particularly in cardiovascular, imaging, and AI-driven healthcare. Foreign manufacturers can leverage their technological edge to capture niche markets through differentiated strategies.

Hot Sectors and Technological Trends: Breakthroughs from AI to Green Healthcare

1. Medical Imaging Equipment: Policy-Driven Growth and Intelligent Upgrades

China’s medical imaging market surged by 47% in 2024, driven by strong sales of CT, ultrasound, and DSA systems¹⁰. Government initiatives, such as the 10-billion-yuan investment in county-level medical consortiums, have fueled demand for advanced equipment like ultra-high-end CT and photon-counting CT. Key opportunities for foreign players include:

• AI-Integrated Devices: Smart diagnostic systems and remote monitoring tools, with Chinese firms expanding AI applications from diagnostics to full-process management⁴¹⁰;
• Green Medical Technologies: Eco-friendly materials and energy-efficient designs, such as biodegradable imaging consumables, align with policy incentives⁶.

2. Cardiovascular and Minimally Invasive Surgical Devices: Focus of Innovation

• Approximately 20% of Class III devices approved in 2024 were cardiovascular interventional products, including "percutaneous ventricular assist devices" and "shockwave vascular penetration systems"⁹¹¹. Minimally invasive surgical device approvals rose by 35%, with imported products leading in electrophysiological navigation systems and surgical robots⁸⁹.

3. IVD and Telemedicine: Post-Pandemic Growth Drivers

China’s IVD export revenue grew by 500% in 2023 and expanded further in 2024. Foreign manufacturers can tap into this market through:

• Localized Partnerships: Collaborating with domestic firms to develop reagents compliant with Chinese regulatory standards;
• Telemedicine Solutions: Products integrating 5G and IoT, such as "remote-controlled bone correction systems"⁹¹¹.

Characteristics of the Chinese Market: Policy Incentives and Structural Opportunities

1. Policy Support: Streamlined Approvals and Funding

• Innovation Fast Track: In 2024, 169 products entered the expedited approval pathway, with 6.5% being imports (primarily from the U.S. and Europe)⁸;
• Financial Subsidies: Jiangsu Province, for example, offers up to 3 million yuan in subsidies for innovative devices and prioritizes their inclusion in medical insurance reimbursement⁸.

2. Aging Population and Grassroots Healthcare Demand

• With over 20% of China’s population aged 60+, demand for chronic disease management tools is boosting the home healthcare device market. Meanwhile, grassroots healthcare facilities are undergoing equipment upgrades, with county-level procurement projected to grow by 25% in 2025⁶¹⁰.

3. Domestic Substitution and Import Complementarity

• While domestically produced devices accounted for 97% of approvals in the first half of 2024³, imported products still hold over 70% market share in high-end imaging, genetic testing, and surgical robotics¹⁰.

Positive Impacts on Overseas Manufacturers

1. Market Access Opportunities

• Understanding the 2024 approval classifications enables foreign manufacturers to align product development and market strategies with China’s evolving regulatory landscape, enhancing entry success.

2. Innovation and Collaboration Potential

• China’s rapid market growth and technological advancements create opportunities for partnerships. Foreign firms can leverage local policy support and funding to accelerate R&D and commercialization while adapting to unique market needs.

3. Market Expansion Prospects

• As China strengthens regulatory oversight and market standardization, overseas manufacturers can capture market share by delivering high-quality, innovative products that meet the demands of healthcare institutions and patients, driving sustainable growth.

Further Information

To read the original article from CAMDI about “Voices from the Two Sessions: What was proposed in the medical device field this year?”, please click here.

If you are a medical device manufacturer with questions about how long it takes or how much it costs to register your product for the China market, please contact Cisema.

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