China Seeks to Update Medical Device Classifications Rules

China is seeking to update the medical device classification rules. On April 7, 2025, the National Medical Products Administration (NMPA) released the Draft Revision of Medical Device Classification Rules for public consultation. The draft introduces updates to classification principles, risk evaluation mechanisms, and regulatory scopes. These changes may directly affect the registration strategy of medical device manufacturers, particularly those with high-risk or imported products. Although feedback is now closed, companies may consider whether the newly proposed rules should be reflected in their approach to classifying products in the China market.

Key Points Overview

• Deadline for Comments: Comments must be submitted by May 7, 2025, via email to wys-xbs@nifdc.org.cn, with the subject line "Feedback on Medical Device Classification Rules."
• Applicability: Applies to medical device classification, directory formulation, dynamic adjustments, and management category determination for new products. Covers the "Medical Device Classification Directory," "Class I Medical Device Product Directory," and all dynamic adjustment contents.
• Advice for Ongoing Registration Projects: Companies should reassess product risk levels based on new rules. If category changes may impact registration, timely communication with regulators and adjustments to application strategies are advised.

Interpretation of Major Revisions

• Refinement and Expansion of Terminology Definitions: 22 New Key Terms: Including "standalone software," "chronic wounds," and "absorbable," clarifying that "implanted devices" must remain in the body for ≥30 days or be absorbable. Detailed Usage Duration: Categorized as temporary (<24 hours), short-term (24 hours–30 days), and long-term (≥30 days).
• Detailed Classification Criteria and Dynamic Adjustment Mechanism: Multi-dimensional Risk Assessment: Combines structural characteristics (active/passive), body contact sites (skin, wounds, circulatory system, etc.), and usage duration for classification. Dynamic Directory Management: The NMPA will regularly evaluate technological developments and risk changes to update the classification directory dynamically.
• Enhanced Regulation of High-risk Products: Expanded Class III Scope: Now includes implanted devices, absorbable materials (non-dressings), drug-device combination products, products with human/animal-derived substances, and standalone software with high-risk functions. Sterilization Requirements Upgrade: Devices provided sterile or sterilized via ethylene oxide/radiation must be at least Class II.
• New Special Scenario Rules: Medical Device Accessories: Classified no lower than the main device if significantly impacting its safety. Combination Packs: Classified according to the highest-risk device within the pack; Class I combination packs must not contain non-devices.

Comparison with 2015 Order No. 15

Compare dimensions Current Rules Revised draft in 2025 Classification principles Focus on the basic risk classification Multi-dimensional judgments such as structural features and time limits are added Dynamic adjustment mechanism The dynamic update process is not specified Establish a mechanism for regular evaluation and dynamic adjustment of the taxonomy High-risk product management Implantable devices and sterile instruments are the third category New absorbable materials, drug-device combination products, independent software, etc Definition of Terms The definition is brief 22 new terms have been added to refine scenarios such as "time limit for use" and "contact with the human body" International harmonization The adaptability of imported products is not emphasized Implicit requirements for the consistency of classification of imported products

Impact on International Companies and Recommendations

• Compliance Challenges for Import Products: Need to reassess product alignment with new standards, especially high-risk categories like implanted devices and products with biologically active components. Pay attention to new clauses on "standalone software" and "sterilization requirements."
• Response Strategies: Collaborate promptly with Chinese partners or professional firms for pre-classification and compliance reviews. Monitor dynamic directory adjustments and plan product registration and launch strategies in advance.
• Encouraged Actions: International companies are encouraged to participate in comment collection or consult Cisema’s professional services to mitigate compliance risks during the policy transition.

Related Links:

• Appendix 1: Rules for the Classification of Medical Devices (Draft Revisions for Solicitation of Comments)
• Appendix 2: Explanation of the revision of the "Classification Rules for Medical Devices (Draft Revisions)" for comments

Further Information

To read the original announcement about the Draft Revision of Medical Device Classification Rules (2025) released by the National Medical Products Administration (NMPA), please click here.

If you are a medical device manufacturer with questions about how these classification changes may affect your registration in China, please contact Cisema.

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