I. 2025 Import Policy Adjustments and Key Points of Consumables Supervision

With the acceleration of globalization in the medical health industry, Chinas regulatory system for imported rehabilitation equipment and its supporting consumables continues to improve. After the implementation of the new 2025 edition of theMedical EquipmentClassification Catalog, 12 dynamic management items have been added to Class III medical devices, including core components such as pressure sensors for neurological rehabilitation equipment and motion function assessment modules, which have been included in the key supervision scope.

Special Attention Required for Imported Consumables Declaration:

• Complete correspondence proof must be established between consumables and main equipment
• Single declaration quantity of consumables must not exceed the theoretical service life matching value of the equipment
• Biocompatible consumables must provide original factory sterilization process verification documents

II. Practical Guide to Complete Customs Clearance Process

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)
  • Dual verification of equipment technical parameters and consumable materials
  • Applicability analysis of tariff preference agreements
• Declaration and customs clearance phase (7-10 working days)
  • Medical Device Registration Certificate and Consumables Correlation Proof
  • Certificate of Special Processing Technology in Country of Origin

III. Core Value Comparison of Professional Agency Services

High-quality agency service providers should possess the following competency matrix:

• Risk prediction systems
  • HS Code Dynamic Database Update Frequency ≤24 Hours
  • Medical Device Classification Pre-judgment Accuracy Rate ≥98%
• Timeliness Control Solution
  • Local Inspection Response Time ≤2 Hours
  • Average Document Correction Processing Cycle ≤1.5 Working Days

IV. Typical Case Risk Prevention Analysis

A Rehabilitation Centers Import of German Gait Trainers Encountered Document Rejection:

• Root Cause: Sterilization Method for Consumables Failed to Specify Radiation Dosage Parameters
• Solution path:
  • Coordinated with Overseas Manufacturer to Issue Notarized Process Description Documents
  • Applied for Fast-track Health Quarantine Channel for Special Items
• Ultimately Saved 11 Working Days in Customs Clearance

V. 2025 Industry Trends and Response Recommendations

According to the latest statistics from the General Administration of Customs, rehabilitationequipment. For example, Indonesia has the SNI certification, Thailand has the TISI certification, and the Philippines has the BPS certification. It is necessary to confirm in advance the equipment voltage (such as 380V/50Hz in Thailand), the compatibility of the CE certification, and the proof of environmentally friendly materials.equipment maintains annual growth rate between 18%-22%, but declaration error rate increased by 7.3% year-on-year. Recommended actions for import enterprises:

• Establish Consumables Batch Management Traceability System
• Select Agency Service Providers with Specialized Medical Device Import Qualifications
• Plan Consumables Replenishment Cycle 6 Months in Advance