NMPA Expands Class I Medical Device Catalog for 2026 | Regulatory Updates

On January 4, 2026, China's National Medical Products Administration (NMPA) issued Announcement No. 132 of 2025 (effective January 4, 2026), introducing significant adjustments to the Medical Device Classification Catalog. This update expands the Class I medical device catalog while refining product descriptions, intended uses, and nomenclature across 31 categories spanning 10 subdirectories. For foreign manufacturers and importers, understanding these changes is essential to ensure proper classification, avoid filing errors, and maintain uninterrupted market access. This guide provides a comprehensive overview of the 2026 catalog expansion, key changes affecting Class I devices, and practical compliance recommendations.

1. Overview of the 2026 Medical Device Classification Adjustment

The NMPA's latest adjustment, announced on January 4, 2026, modifies the Medical Device Classification Catalog across 10 subdirectories, 23 primary product categories, and 31 specific product types. The affected subdirectories include passive surgical instruments, physical therapy devices, dental instruments, passive implantable devices, rehabilitation equipment, and clinical laboratory instruments, among others. The primary changes encompass management class adjustments, product description refinements, intended use clarifications, expanded material scopes, and increased product name examples.

This update aligns with the Medical Device Classification Catalog Dynamic Adjustment Working Procedure and the broader goal of modernizing China's medical device regulatory framework. By adapting classification rules to current clinical practices, emerging technologies, and international standards, NMPA aims to create a more risk-proportionate regulatory environment that reduces unnecessary burdens on lower-risk devices while maintaining robust oversight for higher-risk products. These revisions are effective immediately from the announcement date, with specific transitional provisions for products at different regulatory stages.

2. Key Class I Medical Device Catalog Additions and Refinements

While the official NMPA announcement does not significantly expand the absolute number of Class I product categories, it introduces several important refinements and specifications that affect how Class I devices are defined, described, and regulated. These changes expand the practical scope of the Class I catalog by providing greater clarity on product boundaries and acceptable characteristics.

2.1 Manual Patient Wheelchair – Down‑classified from Class II to Class I

The most notable change affecting the Class I catalog is the down‑classification of manual patient wheelchairs from Class II to Class I. This adjustment reflects a lower perceived clinical risk profile for manually operated (non‑powered) wheelchairs and significantly reduces the regulatory burden for manufacturers of these devices. Under the new classification, manual wheelchairs can now be placed on the market via a straightforward product filing (备案) rather than the more rigorous registration (注册) process required for Class II devices. This change creates market access opportunities for manufacturers who previously found Class II registration cost‑prohibitive. However, importers should note that any wheelchair incorporating electrical components or powered functionality remains in Class II or higher depending on specific risk characteristics.

2.2 Ultrasound Therapy Equipment Accessories – Class I with Sterility Distinction

Adjustments to ultrasound therapy equipment accessories introduce a critical distinction based on sterility. Non‑sterile accessories remain classified as Class I, while sterile versions of the same accessories are now classified as Class II. This change acknowledges the increased risk associated with sterile products intended for invasive or tissue‑contacting applications. Manufacturers producing non‑sterile ultrasound coupling gels, positioning pads, or similar accessories can continue using the Class I filing pathway. However, companies that wish to market sterile versions must undergo Class II registration, including technical documentation review and quality system assessment.

2.3 Physical Cooling Devices – Strictly Limited Scope

Under the 2026 update, physical cooling devices (catalog code 09-02-03) face stricter limitations. These products are now clearly defined as devices intended for localized cooling of fever patients, limited to application on intact skin only. Additionally, such products cannot contain any ingredients that exert pharmacological, immunological, or metabolic effects, including pharmaceutical drugs, chemical compounds, biological products, disinfectants, antimicrobial agents, natural plant extracts, or any absorbable components. The NMPA has also deleted product name examples such as “medical cold compress,” “medical cold headband,” “medical cold eye mask,” and “cooling gel” from the catalog to prevent product scope expansion.备案申请人 must use the exact “product name examples” specified in the catalog and may not invent alternative names. The product description must detail the specific composition, and the intended use cannot exceed the catalog-defined scope.

2.4 Acupoint Pressure Stimulation Devices (20-03-11) – Functional Limitations

Acupoint pressure stimulation devices (catalog code 20-03-11) now have a clearly defined functional limitation: they must not exert infrared radiation, magnetic therapy, or similar effects, and cannot contain components with pharmacological, immunological, or metabolic activity. This clarification helps manufacturers distinguish between low‑risk acupoint pressure devices (Class I filing pathway) and higher‑risk electrotherapy or radiation‑based devices requiring registration. Products previously filed under this category that incorporate heating elements, electromagnetic fields, or active energy sources must now be re‑classified and likely require Class II registration.

3. Management Class Adjustments Affecting Class I Boundaries

While the primary focus of this article is the expansion and clarification of the Class I catalog, several management class adjustments for other categories indirectly affect the Class I landscape by clarifying which products move into or out of the Class I pathway.

3.1 Devices Down‑classified from Class III to Class II

The following devices were down‑classified from Class III to Class II, making them subject to registration rather than the more stringent Class III requirements, but they remain outside the Class I catalog:

• Delivery Guide Devices (e.g., Single‑use Sterile Delivery Guide): renamed from previous terminology and down‑classified from Class III to Class II.
• Inner Ear Prostheses: now divided by intended use. Tympanic ventilation tubes, middle ear ventilation/drainage tubes used for secretory otitis media, Eustachian tube dysfunction, or tympanic membrane retraction are Class II. However, tympanoplasty and stapedoplasty prostheses used for ossicular chain reconstruction or otosclerosis treatment remain Class III.
• Assisted Reproduction Micro Instruments, In Vitro Assisted Reproduction Fluids, and Specialized Instruments for Assisted Reproduction were all incorporated into the adjusted catalog with clarified class assignments, generally remaining in Class II or III depending on risk.

These down‑classifications reduce the regulatory burden for manufacturers of these devices but do not place them into the Class I filing pathway.

3.2 Devices Up‑classified for Enhanced Oversight

Some products were up‑classified due to increased risk perception. Sterile versions of isolation membranes (透声膜) moved from Class I to Class II, reflecting the higher risk of infection when sterile devices are used in clinical settings. Other products such as certain ultrasound therapy accessories (sterile versions) were also up‑classified to Class II. Manufacturers should carefully review product specifications to determine whether their devices require the more rigorous Class II registration pathway.

4. Product Description and Intended Use Refinements

Beyond management class changes, the 2026 adjustment introduces important clarifications to product descriptions and intended uses across multiple catalog entries, many of which affect how Class I devices are defined.

4.1 Teeth Whitening and Dental Materials

Teeth whitening agents, abrasive and polishing materials (for intraoral use), desensitizing agents, caries prevention materials, and teeth whitening materials now explicitly include the statement: “cannot replace toothpaste for daily tooth cleaning.” Some of these products also require that they be handled or applied by qualified dental professionals. These clarifications help prevent consumer misuse and ensure that only appropriately qualified personnel apply higher‑risk dental materials. Manufacturers should ensure that product labeling and instructions for use reflect these clarified restrictions.

4.2 Obstetric and Gynecological Products

Non‑sterile obstetric and gynecological examination pads (医用检查垫) now include the clarifying note: “not intended for use as feminine hygiene products during menstruation.” This prevents off‑label use and ensures that products not designed for sanitary protection are not marketed as such. Additionally, vaginal irrigation/drug delivery devices, medical gynecological pads, gynecological physical therapy devices, and gynecological prosthetic devices were refined with more detailed product descriptions to prevent scope creep.

4.3 Acupoint Pressure Stimulation Devices – Non‑functional Requirements

As noted above, these devices must not emit infrared radiation, provide magnetic therapy, or contain any active ingredients. The updated description reinforces that only purely mechanical pressure devices qualify as Class I. Any device with additional therapeutic functions must be re‑classified upward.

5. Expanded Material Scopes and New Product Categories

The 2026 adjustment also expanded material scopes for several product categories, creating new compliance considerations for manufacturers of implantable and absorbable devices.

• Hemostatic clips (闭合夹): Now explicitly includes biodegradable magnesium alloy hemostatic clips, expanding the material options for this product category.
• Single/Multi‑component Absorbable Bone Fixation Devices: Clarified with new material specifications and indications.
• Sports Injury Soft Tissue Repair and Reconstruction Implants: Added with detailed product descriptions and intended uses.
• Collagen Scaffold Materials and Collagen Patch Dressings: Refined descriptions to align with clinical practice.
• New product categories added: Tendon Repair Patch, Absorbable Rotator Cuff Repair Membrane, and Tympanic Ventilation Tubes as distinct entries.

Manufacturers developing products using biodegradable or bioresorbable materials should carefully review the updated catalog to determine whether their products are now explicitly covered and whether any new testing or documentation requirements apply.

6. Immediate and Transitional Implementation Requirements

The NMPA has established clear transitional provisions for products at different stages of regulatory review, directly affecting manufacturers seeking Class I filing or other approvals.

• New applications submitted after January 4, 2026 must follow the updated classification and naming conventions. This includes any new Class I filing submissions, which must use the revised product descriptions, intended uses, and permitted product name examples.
• Pending applications already accepted for review will generally be processed under the original classification. However, if approved, the registration certificate will note the adjusted product class in the remarks section, and the applicant should be prepared to address any classification‑related questions during review.
• For devices down‑classified from Class II to Class I (e.g., manual wheelchairs), existing registration certificates remain valid until their expiration date. Before the certificate expires, the manufacturer must complete product filing (备案) with the appropriate provincial or municipal authority under the new Class I framework. No immediate action is required, but manufacturers should begin preparing filing dossiers well in advance of certificate expiry to avoid market gaps.
• For devices down‑classified from Class III to Class II, existing certificates remain valid. For renewal, applicants must submit a renewal application under the new classification at least six months before certificate expiry. Renewed certificates will reflect the adjusted class.
• For devices up‑classified from Class I to Class II (e.g., sterile isolation membranes), manufacturers must transition to the Class II registration pathway before the next regulatory action (renewal or modification). Products previously filed as Class I may not be legally marketed without proper Class II registration after the transitional period.

In all cases, the NMPA has structured these transitional provisions to minimize disruption to ongoing market access while ensuring eventual full compliance with the updated catalog.

7. Impact on Foreign Manufacturers and Importers

For international medical device companies, the 2026 catalog adjustments create both opportunities and compliance obligations.

• Opportunities from down‑classification: Manual wheelchairs moving from Class II to Class I significantly reduces the regulatory burden for manufacturers of these devices. The Class I filing pathway requires less clinical evidence, no mandatory quality system audit, and lower ongoing compliance costs. Foreign manufacturers without an existing China presence can now bring manual wheelchairs to market through a local filing agent without the time and expense of full registration.
• Re‑evaluation required for products with refined descriptions: Products such as physical cooling devices, acupoint pressure stimulators, and dental materials must be carefully reviewed against the updated product descriptions and intended uses. Any existing product that no longer fits the refined description must be re‑classified, which may require moving to a higher class or, in some cases, discontinuing the product.
• Up‑classification risk for sterile products: Foreign manufacturers offering sterile versions of products that are Class I in non‑sterile form (e.g., ultrasound therapy accessories) must obtain Class II registration. This requires a full registration dossier, including technical documentation, clinical evaluation, and quality system assessment. Manufacturers should plan for extended timelines and higher costs compared to Class I filing.
• Material scope expansions: Manufacturers of biodegradable magnesium alloy clips or other newly listed materials can now market these products under defined categories. However, the addition of new material scopes may also imply new testing requirements (e.g., biocompatibility, degradation studies).

All importers should conduct a comprehensive classification review of their product portfolios against the updated catalog and develop transition plans for any products affected by class changes or description refinements.

8. Practical Compliance Roadmap for Affected Manufacturers

To navigate the expanded Class I catalog and broader classification adjustments, foreign manufacturers should follow this step‑by‑step approach:

1. Catalog gap analysis (Month 1): Obtain the full “Medical Device Classification Catalog Adjustment Table” from the NMPA announcement (available as an annex to Announcement No. 132 of 2025). Map each product in your portfolio to the updated catalog entries, paying special attention to products with refined descriptions, changed intended uses, or modified material scopes.
2. Classification re‑determination (Month 1‑2): For products where the catalog adjustment changes classification (either up or down), formally re‑determine the classification using the updated criteria. For products near classification boundaries, consider applying for a formal classification determination (分类界定) from NMPA to avoid future disputes.
3. Implement transitional actions (Month 2‑4):
   • For devices down‑classified from Class II to Class I, prepare product filing dossiers (备案资料) including product technical requirements, test reports (if required), and labeling. Submit the filing before the existing registration certificate expires.
   • For devices up‑classified from Class I to Class II, initiate the registration process, including technical documentation compilation, clinical evaluation, and quality system documentation. Allow 12‑18 months for Class II registration.
   • For devices with refined descriptions or intended uses that no longer match, update labeling and instructions for use to reflect the clarified wording. If the product cannot meet the refined description, discontinue the product or apply for re‑classification.
4. Update labeling and regulatory documentation (Month 3): Ensure that all affected products have updated Chinese labeling that reflects any changes in product name examples, intended uses, or precautionary statements. Revise technical files, risk management reports, and quality system documentation to align with the updated classification.
5. Engage a local regulatory agent (ongoing): For foreign manufacturers without a China legal entity, a local filing agent or regulatory agent can manage classification reviews, filing submissions, and communications with provincial NMPA authorities. Select an agent with specific experience in the adjusted catalog and related transitional provisions.

Total time for full transition depends on the number of affected products and the extent of changes. For simple classification reviews and labeling updates, 2‑3 months may suffice. For products requiring registration due to up‑classification, allow 12‑18 months.

Summary: The NMPA’s 2026 Medical Device Classification Catalog expansion and refinement bring important changes for Class I devices and across all management classes. Key updates include the down‑classification of manual wheelchairs to Class I, stricter limitations on physical cooling devices and acupoint pressure stimulators, removal of liquid/paste dressings from Class I, up‑classification of sterile accessories to Class II, and refined product descriptions across dental, obstetric, and therapeutic device categories. Foreign manufacturers must conduct gap analyses, re‑determine classifications, update labeling, and execute transitional actions before existing certificates expire. By proactively adapting to the updated catalog, manufacturers can continue accessing China's medical device market efficiently and compliantly.