China's NMPA Updates Medical Device Classification Catalogue, Affecting 31 Categories

On January 4, 2026, China’s National Medical Products Administration (NMPA) issued “Announcement on Adjusting Certain Contents of the Medical Device Classification Catalogue (No. 132 of 2025).” Effective immediately, the announcement introduces targeted adjustments to the “Medical Device Classification Catalogue,” affecting 31 categories of medical devices.

The adjustments span a broad range of product types, including:

• Passive surgical instruments
• Respiratory and anesthesia devices
• Implantable devices
• Dental instruments
• Reproductive medicine tools
• Rehabilitation equipment
• Clinical laboratory instruments

For international manufacturers, the updated catalogue underscores the need for a timely review of existing registrations, pending applications, and pipeline products to ensure continued compliance with China’s evolving regulatory requirements.

At a Glance: China’s Updated Medical Device Classification Catalogue

The revised catalogue introduces both technical and regulatory management changes that directly affect product classification and registration strategy.

• Scope: 31 medical device categories are affected, with all changes effective immediately.
• Technical revisions: Updates to product descriptions and classification criteria, including expanded material scopes, new sterility requirements, clarified intended uses, and standardized terminology.
• Regulatory reclassification: Certain products have shifted between risk classes, altering applicable registration pathways and review timelines.
• Compliance implications: Classification changes may affect testing requirements, documentation depth, and overall approval timelines.
• Action Steps for Manufacturers: Review product portfolios, update documentation, and consult regulatory experts to ensure compliance — get in touch with Cisema today for expert support.

Technical Revisions Across Key Device Categories

The updated catalogue introduces specific changes across a broad range of product categories, designed to ensure regulatory alignment with current clinical practices and risk profiles.

Several of the most impactful revisions are outlined below.

Clamping Devices: Expanding Material Scope

The material scope for clamping devices has been formally expanded. Previously focused on chemically synthesized or polymer-based materials, the revised catalogue now explicitly includes both metals and polymers.

Notably, “resorbable magnesium alloy clamps” are listed as an example, signaling regulatory recognition of absorbable metal technologies. Classification criteria have also been refined to consider factors such as postoperative removal and in-body retention time, better aligning regulatory classification with clinical practice.

Respiratory and Anesthesia Equipment: Enhanced Sterility Standards

For respiratory and anesthesia devices, nasal oxygen cannulas are now required to be supplied in a sterile state. This change reflects heightened attention to infection control and patient safety during respiratory support procedures.

Manufacturers supplying non-sterile configurations should immediately assess the impact on existing approvals and technical documentation.

Dental Materials: Clearer Usage Guidelines

Updates to the intended use descriptions for dental products, such as teeth whitening agents, desensitizers, and anti-caries materials, now include clear warnings, such as that these items are not substitutes for toothpaste used in daily oral hygiene. This change ensures that patients understand the proper use of these products, helping to prevent misuse and promoting safer dental care practices.

Assisted Reproductive Medicine Tools: Standardized Terminology and Expanded Scope

In the field of assisted reproductive medicine, terminology has been standardized, with “assisted reproductive micro-tools” now renamed as “assisted reproductive tools.” Additionally, the scope of in vitro assisted reproduction fluids has been expanded, with new examples like granulosa cell removal solutions now included.

Obstetrics and Gynecology Devices: Naming and Intended-Use Clarifications

Several obstetrics and gynecology products have also been updated for clarity. The term “vaginal douche” has been standardized as “vaginal irrigation device,” aligning naming conventions with clinical terminology.

In addition, the intended use of “medical gynecological pads” is now clearly defined to distinguish these products from general hygiene items, reducing classification ambiguity.

Changes in Device Classification

In parallel with technical updates, the NMPA has adjusted the regulatory classification of several products. These changes directly affect registration pathways, review timelines, and compliance costs, reflecting updated assessments of clinical risk and product maturity.

Key classification changes include:

Product CategoryPrevious ClassNew ClassPrimary Reason for AdjustmentManual WheelchairsIIIMature technology with low clinical riskDevice Delivery SystemsIIIIIRe-evaluated risk profile for specific usesMiddle Ear ProsthesesIIIII (Ventilation tubes)Refinement of intended use for ventilation. Tympanoplasty/stapedial prostheses are classified as Class IIISterile Isolation Acoustic MembranesIIIHeightened focus on cross-infection risks

Implementation Timelines and Compliance Requirements

To manage the transition, the NMPA has established specific protocols for products currently in the registration pipeline and those already holding valid certificates. These measures ensure that the shift to the updated “Medical Device Classification Catalogue” does not cause undue disruption to the supply of essential medical technologies while upholding safety standards.

The applicable approach depends on product status:

• New Applications: As of the announcement date, all new submissions must follow the updated classification and naming conventions.
• Pending Applications: Products already submitted but not yet approved will be reviewed under the original classification. However, the new class will be noted in the remarks of the final certificate.
• Downgraded Classifications:
  • Class III → II: Registration certificates remain valid. Renewal must follow the new classification.
  • Class II → I: Registration certificates remain valid. Before expiry, the product must be filed for registration under the new class.

Practical Compliance Steps for Overseas Manufacturers

For overseas manufacturers, timely assessment of these classification changes is critical. Because device classification determines testing requirements, documentation depth, and clinical evaluation pathways, even limited adjustments can materially affect regulatory planning.

To maintain compliance and market access, companies should consider the following actions:

Step 1: Conduct a Thorough Internal Review

Begin by thoroughly reviewing all of your marketed, pending, and planned products in light of the official Adjustment Table. This will help identify which products are affected by changes in classification, product description, or intended use.

Step 2: Evaluate the Impact

After identifying affected products, assess how the changes influence regulatory and commercial plans:

• Downgraded products: Evaluate the cost and time advantages of simplified registration or filing and adjust your launch schedule accordingly.
• For products with revised descriptions or intended uses: Assess implications for both ongoing and upcoming registration projects, focusing on resource reallocation and timeline adjustments.
• For expanded or clarified product scopes: Explore whether these changes create new opportunities. This could include better product positioning, market expansion, or new strategic avenues.

Step 3: Update Technical Documentation and Labeling

Ensure that all technical documentation is updated appropriately. This includes revising product technical summaries, manuals, and labels to reflect the revised descriptions and intended uses mandated by the new classifications.

Step 4: Prepare for Registration Certificate Lifecycle Management

With the updated classifications in mind, carefully track the expiration dates for your existing product certificates. This foresight allows you to proactively plan for renewals or new filings that will be required under the updated classification.

Step 5: Seek Professional Guidance for Complex Transitions

Given the complexity of these adjustments — particularly changes in classification or product description — engaging experienced local regulatory consultants, such as Cisema, can be valuable. Their support can streamline the compliance process, mitigate execution risks, and ensure that your transition is as smooth and efficient as possible.

Navigating Evolving China NMPA Medical Device Classification Landscape

As China’s medical device regulatory framework continues to evolve, it’s critical for international manufacturers to stay current with the latest catalogue adjustments. These revisions reflect a broader shift toward more precise, risk-based regulation and a heightened focus on supporting innovation in the medical technology space.

To successfully navigate this evolving regulatory environment, you need a combination of strategic planning and regulatory insight. Cisema supports international manufacturers across the full regulatory lifecycle, from classification analysis and registration planning to approval support and post-market compliance.

To ensure your product portfolio stays aligned with the latest NMPA requirements and to avoid any disruptions in market access, contact Cisema today.

Further Information

• Explore Cisema’s China NMPA medical device registration services to ensure a smooth and efficient path through China’s regulatory requirements.
• Learn more about Cisema’s China NMPA legal agent services to receive expert support with local compliance and representation.

References

• Read the original announcement in Simplified Chinese on the NMPA’s official site: Announcement of the State Food and Drug Administration on Adjusting Part of the Catalogue of Medical Devices (No. 132 of 2025)
• Download the Table of Adjustments to Certain Contents of the Medical Device Classification Catalogue (Simplified Chinese)