Medical EquipmentPain points in the import industry

The latest customs data for 2025 shows that medicalEquipment ImportsThe error rate in declarations is as high as 37%, with 68% of the return cases concentrated in...Incorrect product classification,The validity period of the registration certificate has expired.,Package damageThree major areas. A multinational medical imaging equipment manufacturer once faced issues due to misclassification of CT machines, resulting in...Demurrage fees exceed 1.2 million yuan., this reveals the particularity of medical equipment imports:

• Classification management is strict: Class I/II/III devices correspond to varying levels of regulatory intensity.
• Complex qualification documents: Dual certification from both the manufacturing country and the importing country is required.
• Time-sensitive customs clearance: Precision equipment has special requirements for storage conditions.

Comprehensive Guide to Customs Clearance Procedures (2025 Revised Edition)

According to Announcement No. 83 of the General Administration of Customs, medical equipmentImport ClearanceRequired to Complete7 core steps:

• Qualification pre-review stage
  • Verification of Medical Device Registration Certificate (validity period not less than 6 months)
  • FDA/CE/MDR certification document compliance review
• Declaration and customs clearance stage
  • HS Code Pre-classification (referring to the 2025 edition of the "Medical Device Classification Catalog")
  • Application for Import License (Approval from the Drug Regulatory Authority is required for Class III devices)
• On - site inspection stage
  • On-site verification of equipment performance parameters
  • Chinese Label Compliance Check (Font Height ≥1.8mm)

Comparison of Core Values Among Professional Agents

Comparing a certain orthopedic device import case, professional agency services can shorten46% of the clearance time:

• Declaration error rate: Self-reported 23% vs agent-reported 3.7%
• Document preparation time: 14 working days for self-handling by the enterprise vs 5 working days for agency processing
• Exception handling cost：The enterprise bears 100% of the risk vs. the agency company assumes full risk coverage.

Compliance Key Points Alert for 2025

According to the latest "Regulations on the Supervision and Administration of Medical Devices," special attention should be paid to:

• At the regulatory level
  • The EU MDR transition period will fully terminate on May 26, 2025.
  • China's NMPA Introduces Special Testing Standards for AI Medical Devices
• Technical level
  • The electromagnetic compatibility test report must include data for the 5G frequency band.
  • Equipment containing radioactive materials requires special permission from the environmental protection department.
• Logistics level
  • The temperature fluctuation of implantable devices throughout the cold chain must not exceed ±2°C.
  • The transportation of large-scale equipment requires prior submission of a special loading and unloading plan.

Practical Case: Crisis Management in the Import of German CT Machines

A certain top-tier hospital imported a 256-slice CT scanner encountered...Double Jeopardy:

• Classification error: Misreported under heading 9018 (diagnostic equipment) when it should actually be classified under 9022 (radiation application equipment).
• Certification Deficiency: Failure to obtain the new version of MDR CE certificate.

Professional agents adoptContingency plan:

• Complete the correction declaration of commodity codes within 3 hours.
• Activate the EU Certification Fast-Track Reissuance Channel
• Coordinate customs inspection and constant temperature warehousing services

Finally, it will30-Day Delay CrisisCompress to 7 working days for resolution to prevent equipment performance from being compromised.

Evaluation Dimensions for Selecting Proxy Services

High-quality medical equipmentImport RepresentationShould have:

• Industry experience: Complete at least 50 cases of importing similar devices.
• Service network：Offices are established in major medical device manufacturing countries.
• Risk Control：Holds the AEO Advanced Certification from Customs
• Response speed: Provide a 7×24 emergency channel for abnormal situations.