Class III Medical Device Registrations Rise in China, Q1–Q3 2025

China’s medical device market is steadily shifting toward high-end, innovation-driven products, according to data from Zhongcheng MedTech and the China Medical Device Industry Association. In the first three quarters of 2025, registration data revealed growing demand for high-risk Class III devices, reflecting China’s focus on healthcare modernization and addressing urgent clinical needs.

For foreign manufacturers of high-risk and innovative devices, these trends indicate strong potential to compete in China’s high-value market segments.

Market Overview: High-End Devices Lead the Shift

China’s medical device registration data from Q1–Q3 2025 reveal three defining trends:

Steady approval activity for high-risk devices
Persistent gaps in domestic manufacturing of critical-care technologies
Continued dominance of imported products in advanced medical segments

The following sections outline these developments in detail.

Overall Approval Trends: Growth in Class III Devices Registration

Between Q1 and Q3 2025, more than 700 new Class II and Class III medical devices were registered across five main categories:

Medical imaging
Radiotherapy
In vitro diagnostics
Surgical devices
Life-support equipment

Although total approvals declined slightly by 4.3% year on year, Class III high-risk devices accounted for 31% of all registrations—a 4.4% year-on-year increase. Notably, registration activity was impressive in high-frequency and radiofrequency surgical equipment as well as surgical robots, with more than 40 approvals recorded in these categories.

Geographically, registration activity remained concentrated along China’s east coast, which accounted for nearly 70% of total national product registrations. Guangdong and Jiangsu led by a wide margin, while Shanghai, Zhejiang, and Beijing also played key roles. Beijing, in particular, stood out for its concentration of high-end technologies, with Class III devices representing nearly half of all approved products in the city.

Domestic Production Gaps: Limited Capacity in Critical Technologies

Several critical product categories remain heavily dependent on imports. Notably, home-use ventilators have a zero-percent domestic share. Other underlocalized segments (<50%) include:

Life-support systems
Cardiopulmonary bypass devices
Advanced imaging devices

For overseas manufacturers, these persistent gaps mark clear entry points where imported products can meet urgent healthcare needs.

Import Activity: Foreign Manufacturers Excel in High-End Approvals

During the reporting period, 32 imported devices—primarily Class III surgical and medical imaging products—received NMPA approval. The United States, Japan, and Germany accounted for 75% of these imports. All imported imaging devices were Class III, reflecting China’s continued dependence on global expertise in advanced medical technologies that address critical clinical needs.

Regulatory and Policy Drivers

This market shift toward more specialized, innovation-driven medical products aligns with China’s ongoing regulatory reforms under the “Regulations on the Supervision and Administration of Medical Devices” and related NMPA implementation measures.

Key priorities include:

Accelerated approval pathways for innovative and clinically urgent devices.
Strengthened risk-based classification and tighter supervision of Class III products.

These measures provide a clearer, more predictable pathway for introducing innovative medical devices.

Next Steps for Foreign Manufacturers

As China’s medical device market evolves toward advanced, innovation-driven products, foreign manufacturers have a clear opportunity to strengthen their presence in high-value segments. Success will depend on focusing resources where market demand, regulatory priorities, and existing portfolio strengths intersect.

The following actions can help companies position effectively for growth:

1. Identify Opportunities in Underlocalized Segments

Assess where your existing portfolio matches persistent gaps in China’s market—especially life-support systems, cardiopulmonary bypass devices, advanced imaging, and home-use ventilators. These categories still depend heavily on imports, presenting strong entry potential for proven foreign technologies.

2. Position Devices Strategically

For innovative or Class III devices, highlight their clinical value and technological differentiation in alignment with China’s focus on clinically urgent healthcare. A clear, data-backed value proposition will strengthen your standing with regulators and potentially accelerate approval.

3. Partner with Local Regulatory and Clinical Experts

Work with experienced regulatory consultants and CROs to manage the complex NMPA approval process. This support can accelerate market entry, facilitate qualification for innovation-focused pathways, and ensure ongoing compliance with China’s regulatory and post-market requirements.

Key Takeaway: Innovation Drives Opportunity in China

China’s 2025 medical device registration data reveal a market increasingly driven by innovation and sustained demand for advanced imported technologies. Growth is strongest in high-risk devices that deliver measurable clinical value—areas where foreign manufacturers hold a clear advantage. As regulatory reforms continue to favor innovative and clinically urgent technologies, foreign manufacturers that can demonstrate strong clinical performance and technological differentiation will be best positioned to succeed.

With more than 20 years of on-the-ground experience, Cisema helps medical device companies translate innovation into market access—guiding NMPA registration, clinical strategies, and long-term compliance. To discuss how your medical devices can successfully enter the Chinese market, contact our experts today.