China Updates Medical Device Classification Catalogue: Impact on Product Risk and Regulatory Strategy (2026)

On 4 January 2026, China’s National Medical Products Administration (NMPA) issued an important regulatory announcement adjusting parts of the Medical Device Classification Catalogue (Announcement No. 132 of 2025). The update introduces targeted changes to the classification and technical descriptions for 31 categories of medical devices, effective immediately.

These revisions reflect the NMPA’s continued effort to modernise regulatory oversight by aligning product categorisation with current clinical practice, technological developments, and risk-based regulation, a cornerstone of China’s evolving medical device framework.

Scope of the Classification Updates

The revised catalogue spans a broad spectrum of device types, including passive surgical instruments, respiratory and anaesthesia equipment, implantable devices, dental instruments, reproductive medicine tools, rehabilitation devices, and clinical laboratory instruments.

The changes are not merely cosmetic: they include updates to product descriptions, expanded material scopes, clarified intended uses, and adjustments to sterility expectations and terminology. These technical refinements can materially influence how products are classified and therefore regulated under China’s medical device regime.

Notable Classification Changes

Several device categories have undergone regulatory adjustments that could alter approval pathways and compliance requirements:

• Certain technologies, such as manual wheelchairs, have been downgraded from Class II to Class I, reflecting a lower perceived clinical risk profile.

• Complex delivery systems previously classified as higher-risk are now downgraded to Class II in some uses, potentially enabling streamlined regulatory pathways.

• Other products, such as biodegradable magnesium alloy clips, illustrate how expanded material definitions and clarified intended uses can affect classification decisions.

In parallel, updated technical descriptions and expanded scopes reduce ambiguity in device naming conventions, including alignment of obstetrics/gynaecology tool definitions and dental materials usage guidelines.

Transitional Provisions and Compliance Requirements

To manage the transition, the NMPA has established clear approaches for products at different stages of regulatory review:

• New Applications: All new submissions submitted after the announcement must follow the updated classification and naming conventions.

• Pending Applications: Devices already accepted for review will generally be processed under the original classification, but the new classification will be noted in final approval remarks.

• Existing Registered Devices: Transition provisions vary by scenario:

For devices downgraded from Class III to Class II, existing certificates remain valid until their current expiry, after which future renewals should align with the new classification.

For devices downgraded from Class II to Class I, transition requires appropriate filing or registration updates before certificate expiry under the new class framework.

These transitional arrangements are designed to minimise disruption to ongoing market access and supply continuity while ensuring regulatory compliance with the updated catalogue.

Implications for Manufacturers and Market Access Strategy

These classification adjustments highlight several important implications for both domestic and international stakeholders:

1. Regulatory Strategy and Planning

Product classification determines not only the applicable registration pathway but also technical documentation expectations, clinical evidence requirements, and submission timelines. Classification changes may therefore necessitate revision of regulatory strategies and internal project planning.

2. Documentation and Dossier Updates

Technical documents, including product descriptions, intended uses, and risk justification, may need revision to conform to the updated catalogue specifications. Manufacturers should ensure that labelling, quality files, and regulatory dossiers reflect current classification criteria.

3. Lifecycle Management and Renewals

As classification impacts renewal pathways and regulatory obligations, companies should proactively map out certificate expiry timelines and prepare for renewals or reclassification where applicable.

4. Market Access and Competitive Positioning

Downgrades can present opportunities to simplify regulatory requirements, reduce compliance burdens, and accelerate market entry, particularly for devices shifting to lower-risk categories. Conversely, expanded scopes or refined definitions may require enhanced controls for safety and performance.

China’s Regulatory Landscape Continues to Evolve

The NMPA’s revision of the Medical Device Classification Catalogue underscores China’s commitment to a dynamic and risk-based regulatory system. By continuously refining classification criteria and aligning them with clinical and technological realities, regulators aim to enhance patient safety while supporting innovation and market predictability.

For manufacturers and authorised representatives targeting the Chinese market, staying abreast of these classification updates and adapting regulatory strategies accordingly will be essential for successful compliance and sustained market access.

Sources:

China NMPA Announcement on Adjustment of Medical Device Classification Catalogue (Announcement No. 132 of 2025) effective 4 January 2026.