Medical EquipmentIndustry pain points in imports

Latest customs data for 2025 shows that medicalEquipment ImportsThe declaration error rate reaches as high as 37%, with 68% of return shipment cases concentrated inProduct classification errors,Expired registration certificates,Package damageThree major areas. A multinational imaging equipment manufacturer once incurredDemurrage fees exceeding 1.2 million yuandue to CT machine classification errors, revealing the unique challenges of medical equipment imports:

• Strict classification management: Class I/II/III devices correspond to different regulatory intensities
• Complex certification requirements: Must meet dual certification standards from both manufacturing and importing countries
• Time-sensitive clearance: Precision equipment has special storage condition requirements

Complete customs clearance process analysis (2025 revised edition)

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

• Qualification pre-review stage
  • Medical device registration certificate verification (validity period no less than 6 months)
  • Compliance review of FDA/CE/MDR certification documents
• Declaration and customs clearance stage
  • HS code pre-classification (refer to the 2025 edition of Medical Device Classification Catalog)
  • Import license application (requires approval from drug regulatory authorities for Class III devices)
• On - site inspection stage
  • On-site verification of equipment performance parameters
  • Compliance inspection of Chinese labels (font height ≥1.8mm)

Core value comparison of professional agencies

Comparing an orthopedic device import case, professional agency services can reduce46% of clearance time:

• Declaration error rate: Self-declaration 23% vs agency declaration 3.7%
• Document preparation time: In-house handling 14 working days vs agency handling 5 working days
• Abnormal handling costs: Enterprises bear 100% risk vs agency companies providing risk coverage

2025 compliance key points warning

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

• Regulatory level
  • The EU MDR transition period will completely terminate on May 26, 2025
  • China FDA has added special testing standards for AI medical devices
• Technical level
  • EMC test reports must include 5G frequency band data
  • Radioactive equipment requires special permits from environmental protection authorities
• Logistics level
  • Temperature fluctuations during the entire cold chain for implantable devices must not exceed ±2℃
  • Transportation of large equipment requires prior declaration of special handling plans

Case study: Crisis management in importing German CT machines

A tertiary hospitals experience importing 256-slice CT scannersDual crisis:

• Classification error: Misdeclared under HS 9018 (diagnostic equipment) when it should be under 9022 (radiation application equipment)
• Certification deficiency: Failed to obtain new MDR CE certificate

Professional agents took actionContingency plan:

• Completed HS code correction declaration within 3 hours
• Activated fast-track EU certification replacement channel
• Coordinated customs inspection and constant-temperature warehousing services

Ultimately reduced30-day delay crisisTo resolution within 7 working days, preventing equipment performance damage

Industry database completeness:

High-quality medical equipment import servicesImport RepresentationShould have:

• Industry experience: Completed at least 50 cases of similar equipment imports
• Service network: Maintain offices in major medical device manufacturing countries
• Risk Control: Hold customs AEO Advanced Certification
• Response speed: Provide 7×24 emergency channels for exceptions