I. Key Points of Import Policy Adjustments and Consumables Regulation for 2025

With the acceleration of globalization in the healthcare industry, China's regulatory system for imported rehabilitation equipment and its supporting consumables continues to improve. The 2025 revised edition of the "Medical devicesAfter the implementation of the "Classification Catalog," 12 dynamic management entries have been added for Class III medical devices, with core components such as pressure sensors and motor function assessment modules for neurorehabilitation equipment being included in the key regulatory scope.

Special attention is required for the declaration of imported consumables:

• Consumables and host equipment must establish a complete corresponding relationship certification.
• The one-time declaration quantity of consumables must not exceed the theoretical service life matching value of the equipment.
• Biocompatible consumables must provide the original manufacturer's sterilization process validation documentation.

II. Practical Guide to End-to-End Customs Clearance Procedures

Taking the import of consumables for a certain brand of lower limb rehabilitation robot as an example, the complete customs clearance process includes:

• Pre-classification phase (3-5 working days)
  • Double verification of equipment technical parameters and consumable materials
  • Analysis of Applicability of Tariff Preference Agreements
• Declaration and customs clearance phase (7-10 working days)
  • Medical Device Registration Certificate and Consumables Relevance Certification
  • Document on Special Processing Techniques for Origin Certification

III. Core Value Comparison of Professional Agency Services

High-quality proxy service providers should possess the following capability matrix:

• Risk prediction systems
  • The update frequency of the HS code dynamic database is ≤24 hours.
  • The accuracy rate of medical device classification pre-judgment ≥98%.
• Time Control Scheme
  • On-site inspection response time ≤ 2 hours.
  • The average processing time for document corrections is ≤1.5 working days.

IV. Analysis of Risk Prevention and Control in Typical Cases

A rehabilitation center's imported German gait trainer encountered document rejection:

• The crux of the issue: The sterilization method for consumables does not specify the irradiation dose parameters.
• Solution path:
  • Coordinate with overseas manufacturers to issue notarized documents of process descriptions.
  • Application for the Fast-Track Health Quarantine of Special Items
• Ultimately, it saved 11 working days in customs clearance time.

V. Industry Trends and Response Recommendations for 2025

According to the latest statistics from the General Administration of Customs, rehabilitationEquipment importThe annual growth rate remains within the range of 18%-22%, but the error rate in declarations has increased by 7.3% year-on-year. It is recommended that import enterprises:

• Establish a consumables batch management and traceability system
• Select an authorized agent service provider with specialized qualifications for medical device imports.
• Plan the consumables replenishment cycle 6 months in advance.