China NMPA Releases 2025 Medical Device Standardization Management Report

On February 24, 2026, the National Medical Products Administration released the “Annual Report on Medical Device Standardization Management in China (2025),” providing a comprehensive overview of regulatory progress, standard development, and international alignment within China’s medical device standards system.

For overseas manufacturers, the report points to a more structured and faster-evolving standards system, requiring closer attention to ongoing updates to support compliant market entry and lifecycle management.

China Expands Medical Device Standards System in 2025

The report confirms that China exceeded its annual targets for medical device standard development and revision in 2025, reflecting both increased output and improved quality of standards.

A total of 94 national standards and 87 industry standards were initiated during the year. Most were newly developed rather than revised, with recommended standards accounting for the majority of outputs. At the same time, 66 national standards and 80 industry standards were formally issued, including mandatory and recommended standards as well as technical guidance documents.

By the end of 2025, China maintained 2,082 valid medical device standards — an 18.4% increase compared with 2020. These standards are primarily concentrated in product standards, which account for more than half of the total system, followed by method and basic standards.

Standards are most heavily focused on:

• Medical laboratory equipment
• General medical devices
• Orthopedic and implantable devices
• Microsurgical and general surgical instruments

This distribution reflects continued regulatory prioritization of core device categories with high clinical demand and technological complexity.

Standardization Infrastructure Continues to Expand

Alongside technical development, China has strengthened its institutional framework for medical device standardization.

The number of national standardization technical organizations increased to 39 in 2025 — representing an 18.2% rise compared with the end of the 13th Five-Year Plan. These include technical committees, subcommittees, working groups, and technical units.

More than 2,100 experts now participate across regulatory, clinical, academic, and industry sectors, forming a multidisciplinary network that supports standard development and review.

Breakthroughs in High-End and Emerging Technologies

The report places particular emphasis on frontier technology standardization.

In 2025, China issued its first industry standards for brain–computer interface (BCI) medical devices, including "YY/T 1987—2025 Medical Devices Using Brain-Computer Interface Technology — Terminology." Additional national and industry standards have been initiated alongside an international standard proposal.

More broadly, 68 industry standards were advanced in strategic emerging fields covering:

• Medical robotics
• Artificial intelligence-based medical devices
• Novel biomaterials
• Companion diagnostics

These efforts are reinforced by the establishment of a national intelligent medical device standardization working group, designed to coordinate cross-disciplinary development in emerging fields.

To address urgent clinical and technological needs, the NMPA introduced accelerated procedures for certain standards — particularly in emerging areas such as BCI — significantly reducing development timelines.

For overseas manufacturers, this indicates a faster-moving regulatory environment in high-end device categories.

International Alignment and Standardization Cooperation Strengthen

China continues to deepen its engagement with global standardization systems while promoting its domestic standards internationally.

The consistency rate between Chinese and international medical device standards reached 93% in 2025, lowering technical barriers for foreign manufacturers already aligned with international norms.

China also expanded its participation in international standardization activities, including:

• 189 international meetings attended
• 596 voting participations
• 76 newly registered international experts

In addition, China led the publication of one ISO standard and continues to lead several ongoing international standard projects, including initiatives related to post-market surveillance for machine learning-based devices.

Seventeen national standards are currently being translated into foreign languages, and China hosted the 31st plenary meeting of ISO/TC 198 (Sterilization of Healthcare Products), reinforcing its role in shaping global consensus.

Increased Transparency and Accessibility of Standards

To support implementation and stakeholder engagement, China has expanded training, consultation, and public access to standards.

The NMPA organized extensive outreach activities, including training sessions covering all technical organizations and thousands of participants. A dedicated interpretation platform published dozens of official explanations and hosted hundreds of training events.

Public consultation mechanisms were also strengthened, with hundreds of draft standards and proposals opened for stakeholder feedback.

Notably, 1,325 standard texts — including all mandatory industry standards — have been made publicly available, improving transparency.

Implications for Overseas Medical Device Manufacturers

The developments outlined in the 2025 report point to a standards system that is broader in scope, faster in execution, and more closely aligned with international frameworks. For overseas manufacturers, the impact is practical and immediate.

Faster Standard Development Requires Earlier Alignment

The pace of standard development, especially in emerging technologies, is accelerating. Companies should actively participate in or align with these rapidly evolving standards, potentially gaining a technological edge monitor early-stage standardization activity to avoid delays in China medical device registration and market entry.

High International Alignment Reduces Gaps

While 93% alignment with international standards lowers technical barriers, products compliant with mainstream international standards generally face lower barriers when entering China. However, localized differences may still exist, often in method standards and management requirements, requiring careful review.

Lifecycle Compliance Expectations Continue to Expand

The increasing number of mandatory standards, alongside the withdrawal of outdated ones, reflects a system that covers the full product lifecycle where compliance extends beyond product specifications into testing methodologies, quality management, and regulatory oversight.

What Companies Should Do Next

To remain aligned with China’s evolving medical device regulatory framework, overseas manufacturers should focus on several key actions:

• Track newly issued and revised mandatory standards to ensure continued compliance
• Monitor fast-developing standards in high-end innovation fields
• Leverage publicly available standards and translation initiatives for technical alignment
• Engage in standardization activities where possible to influence future requirements

The direction outlined in the “Annual Report on Medical Device Standardization Management in China (2025)” underscores a clear shift toward more dynamic and accessible standard-setting in China. For manufacturers, the ability to interpret and respond to these changes in real time is becoming a key factor in maintaining compliance and securing timely market access.

Staying ahead of that pace — across mandatory updates, emerging technology standards, and localized technical requirements — demands consistent, specialized attention. Cisema supports international manufacturers in tracking China medical device standards, interpreting technical requirements, and aligning documentation with NMPA expectations. To assess how recent standardization updates may affect your product portfolio and regulatory strategy, contact Cisema today.

Further Information

Explore Cisema’s medical device registration services in China for detailed guidance on NMPA submission pathways, documentation requirements, and compliance strategy.

References

• Acess the official “Annual Report on Medical Device Standardization Management in China (2025)” published by the NMPA
• Review the prior “Annual Report on Medical Device Standardization Management in China (2024)” for year-on-year regulatory context