China NMPA Releases 2025 Medical Device Registration Data Report

On February 24, 2026, the National Medical Products Administration (NMPA) released the “2025 Annual Report on Medical Device Registration,” outlining key approval statistics and regulatory trends shaping China’s medical device market.

With 6,040 imported medical device registrations approved (42.6% of total approvals), imported products continue to play a critical role in China’s healthcare system, particularly in high-end and technologically advanced segments.

For foreign manufacturers, the data demonstrates sustained market access opportunities in innovation-driven areas, alongside the need to strategically leverage accelerated approval pathways.

Approval Volumes Reflect Continued Market Expansion

The latest data confirms sustained growth in China medical device regulation activity, with both approvals and applications reaching new highs. The report signals continued regulatory efficiency and strong market demand across device categories.

Key figures include:

• 14,187 total approvals — up 8% year-on-year
• 6,040 imported approvals — up 6.5%
• 14,647 applications accepted — up 5.9%
• 76 innovative devices approved — up 17%
• 25 priority review approvals — up 212.5%

Lifecycle Management Dominates Imported Registrations

A closer look at registration types shows that most imported devices are already established in the Chinese market.

• First-time registrations: 642 (Class II: 270; Class III: 372), accounting for 10.6%, slightly up from 9.8% in 2024
• Renewals: 2,600 (Class II: 1,450; Class III: 1,150), accounting for 43.0%
• Modifications: 2,798 (Class II: 1,382; Class III: 1,416), accounting for 46.4%

The relatively smaller share of first-time approvals indicates a mature installed base, while ongoing renewals and modifications reflect active lifecycle management and product upgrades.

Leading Source Countries Consolidate Market Position

The geographic distribution of imported devices remains concentrated among established global markets. 2025, products from 30 countries were approved, with the top five accounting for more than 75% of first-time registrations.

Top Contributors to First-Time Registrations

• United States: remains the largest source, dominant in cardiovascular, diagnostic imaging, and surgical robotics
• Germany: second largest source, strong in orthopedics and surgical instruments
• South Korea and Japan: growth in aesthetic, endoscopy, and ophthalmology devices
• France: stable presence in cardiovascular and orthopedic segments

Together, these five countries contributed approximately 484 first-time registrations, with the United States accounting for nearly half of that total.

High-Growth Product Categories Signal Shifting Demand

Product category trends reveal evolving clinical demand and technology adoption across China’s healthcare system. Imported devices covered 21 subcategories, with notable shifts in ranking.

Dentistry and Ophthalmology Lead Expansion

Dental devices became the top category, growing 24% year-on-year and overtaking passive implants. This growth is driven by demand for:

• High-end dental implants
• Digital restorative solutions
• Orthodontic technologies

Ophthalmic devices recorded the fastest growth at 35.2%, reflecting rising demand linked to:

• Myopia control
• Cataract treatment
• Retinal diagnostics

Imaging Devices Enter Top Tier

Medical imaging devices ranked among the top five for the first time, supported by sustained demand for advanced CT, MRI, and ultrasound systems.

Meanwhile, some traditional categories, including passive implants and certain surgical devices, showed slower growth or slight declines, possibly due to increasing domestic substitution.

Imported IVDs Continue to Support Diagnostic Demand

Imported in vitro diagnostic (IVD) reagents remain a key segment within China’s regulatory landscape. In 2025, 1,623 imported IVD approvals (Class II: 1,195; Class III: 428) were granted, representing 26.9% of all imported device approvals.

These products primarily serve high-demand diagnostic areas such as:

• Immunoassay
• Molecular diagnostics
• Point-of-care testing (POCT)

This sustained volume reflects continued reliance on international technologies in advanced diagnostics.

Innovation Pathways Accelerate Access for Advanced Technologies

The NMPA’s special approval pathways continue to play a critical role in accelerating access to cutting-edge technologies. The report confirms record activity under innovation-focused mechanisms.

By the end of 2025, 391 innovative medical devices had been approved cumulatively, including 55 imported products from 30 companies across 6 countries.

Key Technology Areas in Innovative Approvals

Among the 76 innovative devices approved in 2025 (number of imported products not disclosed), key areas include:

• Active and implantable surgical devices
• Structural heart interventions
• Ophthalmology technologies
• Neuro and cardiovascular surgical systems

Examples of advanced technologies entering China through these pathways include:

• Pulsed field ablation (PFA) systems
• Transcatheter valve repair devices
• 7T MRI systems with AI integration
• Compact proton therapy systems

These products typically demonstrate strong clinical value and hold intellectual property advantages, aligning with NMPA criteria for innovation and priority review.

Strategic Implications for Foreign Manufacturers

The 2025 report provides clear signals for international companies planning China market entry or expansion. Regulatory trends indicate both opportunity and increasing sophistication in compliance expectations.

Target High-Growth and High-Value Segments

Foreign manufacturers of product categories with strong demand and limited domestic substitution, including:

• Dental and digital dentistry solutions (see our article on dental device registration in China)
• Ophthalmic devices and vision care technologies
• High-end imaging equipment, particularly CT, MRI, and advanced ultrasound systems

Beyond initial market entry, competitiveness increasingly depends on product differentiation. Upgrading existing product lines is therefore essential, particularly in established categories.

Key upgrade directions include:

• Passive implants: transitioning to biodegradable materials, drug coatings, and biomimetic structures
• Active surgical devices: integrating robotic assistance, intelligent sensing, and multi-modal technologies

These enhancements enable imported manufacturers to replace legacy products and strengthen positioning within mature market segments.

Leverage Accelerated Approval Pathways

Foreign manufacturers should actively evaluate whether their products qualify for innovation or priority review pathways, as these routes can significantly reduce time-to-market in China.

Eligibility is typically based on:

• “First-in-China” status
• Patent protection
• Demonstrated clinical value

Companies with qualifying products should prioritize these pathways early in their China registration strategy, as pathway selection directly impacts approval timelines and resource planning.

Particular attention should be given to high-impact technology areas where accelerated pathways are already being applied, including:

• Pulsed field ablation (PFA): Safer alternative to RF ablation for atrial fibrillation; multiple systems approved
• Transcatheter valve repair: Minimally invasive treatments for mitral and tricuspid valves becoming mainstream
• Neuromodulation & brain-computer interfaces: High-barrier products such as deep brain stimulation for addiction and extravascular defibrillation filling domestic gaps
• Advanced diagnostics: Digital PCR, 7T MRI, proton therapy systems

These products benefit from accelerated approval via innovation or priority pathways, reflecting China’s openness to globally novel and clinically urgent technologies.

Partner with Experienced Regulatory Experts

Given the high volume of renewals and modifications in China, effective post-approval management and early regulatory alignment are essential to sustaining market access. Working with an experienced regulatory partner, such as Cisema, can help foreign manufacturers navigate both lifecycle requirements and cross-market regulatory differences more efficiently.

Key areas of support include:

• Managing post-approval changes, such as indication expansions, material or design upgrades, and smart or digital enhancements
• Conducting regulatory gap analysis between China and other jurisdictions, such as the United States, European Union, and Japan
• Identifying and addressing documentation and testing gaps early to reduce review timelines
• Streamlining submission preparation to improve approval efficiency and success rates

Through proactive regulatory planning and comprehensive medical device lifecycle management, companies can accelerate market entry timelines and optimize long-term performance in China.

Outlook for China Medical Device Regulation

For overseas manufacturers, the NMPA’s 2025 data signals a regulatory environment increasingly structured around innovation, with clear pathways to accelerate clinically valuable and first-in-class technologies. Imported medical devices remain essential in high-end and technically complex segments, even as domestic capabilities continue to advance.

To capitalize on this opportunity, experienced regulatory support is critical. With over 20 years of on-the ground experience in China, Cisema provides end-to-end support for NMPA medical device registration, including pathway assessment, submission strategy, and lifecycle compliance management.

For foreign companies planning market entry or expansion in China, contact Cisema today to assess regulatory options and define an efficient medical device registration strategy.

Further Information

• Explore Cisema’s services for medical device registration in China
• Gain insights into dental device registration in China in our article
• Refer to Cisema's China Class II and III Medical Device Approval Tracker to see approval trends over the past three years.

References

The official NMPA reports are available below:

• Review the official NMPA publication: “2025 Annual Report on Medical Device Registration” (Simplified Chinese)
• Compare with prior year data: “2024 Annual Report on Medical Device Registration” (Simplified Chinese)