The NMPA Center for Medical Device Standardization Administration issued the “Notice on Soliciting Opinions on Adjustments of the Medical Device Classification Catalog” on August 7, 2025. Feedbacks need to be submitted by September 10, 2025. The document demonstrates NMPA’s commitment to improve regulatory clarity and align the risk-proportionate oversight with global regulatory best practices.
For the medical device classification catalog, please click HERE
NMPA’s new device classification rules took effect in September, 2024. Click HERE to learn more
Downgraded Classifications
Central to the proposal is the downgrading of certain device classifications based on accumulated real-world evidence:
- Delivery introducers transition from Class III to Class II.
Delivery introducer typically consists of a guidewire needle and a control stopcock. It is intended to guide the guidewire into the vessel. One of the examples is single-use sterile connector.
- Manual wheelchairs shift from Class II to Class I
- Medical image printers maintain Class I status but now feature technology-specific subcategories (laser dry/thermal dry imaging)
Clarifications for Market Access
The update resolves critical ambiguities in regulatory submission:
- Nasal oxygen delivery systems now feature explicit distinctions:
• Sterile versions (Class II) requiring full quality system compliance
• Non sterile variants (Class I) with streamlined requirements - Dental sector refinements (affecting 7 categories) establish clear boundaries:
• Teeth whitening/caries prevention materials explicitly excluded from daily oral hygiene classifications
• Intraoral vs. extraoral polishing agents receive distinct regulatory treatment
• Standardized “Dental” prefix applied to product nomenclature
Which Indications Being Most Affected
Specialized fields benefit from the regulatory adjustments:
- Reproductive health adopts modern terminology (“Assisted Reproductive Tools”) while expanding scope for embryo-handling apparatus
- Orthopedic innovations gain formal pathways including:
• Degradable magnesium alloy closure clips
• Consolidated sternal fixation categories maintaining Class III rigor
• Expanded tendon repair indications for sports medicine implants - Collagen scaffolds now formally include cartilage regeneration applications beyond dermatology
Takeaways for Overseas Manufacturers
This regulatory update positions China’s medical device market as increasingly accessible within a structured, internationally recognizable framework, shaping more efficient pathways for advanced medical technologies to reach Chinese patients. It creates new opportunities through:
- Regulatory predictability – Explicit reclassification tables enable overseas manufacturers to plan Chinese registrations with greater certainty in timelines, testing needs, and dossier content.
- Burden reduction for mature technologies – Evidence-driven downgrades (e.g., manual wheelchairs, delivery introducers) significantly reduce clinical data and quality system audit requirements
- Terminology harmonization – Standardized product naming conventions (e.g., “Dental” prefix, unified reproductive health terminology) align with internationally used descriptors,
- Expanded market scope – Newly recognized indications and material uses (e.g., collagen scaffolds for cartilage repair, magnesium alloy closure clips) open additional sales channels and allow existing CE/FDA-cleared products to enter China without major design changes.
