Three checkpoints for pre-import qualification preparation

MedicalEquipment ImportsMust passTriple Qualification Verification System: The importer must hold the ,Medical EquipmentBusiness License, with business scope covering the corresponding equipment category; imported products must complete registration with the Drug AdministrationImport medical device filing(Filing number valid until 20251 February); Overseas manufacturers must possessISO 13485 quality management system certification.

Special requirements for product certification

Unlike ordinary commodity imports, medical devices must complete:

• CFDA registration certification(New AI diagnostic equipment classification added from 2025)
• For Class III medical devicesClinical trial reports
  • Must include data from no fewer than 3 Grade A tertiary hospitals
  • Trial duration must be no less than 6 months
• Radiation equipment requires additionalEnvironmental approval documents

The golden section point of customs clearance strategy

Select the optimal customs clearance solution based on equipment usage scenarios:

• General trade mode(For end-hospital use)
  • Advantage: Can be immediately put into clinical use
  • Disadvantage: Requires full payment of 13% VAT
• Bonded zone model(For display/R&D purposes)
  • Advantage: Deferred payment of import taxes
  • Disadvantage: Equipment must remain within supervised areas

Precision control of logistics solutions

Medical equipment transportation requires establishment ofDual protection mechanism:

• Adoption of precision instrumentsAir cushion shock-absorbing containers
• Full-process temperature control equipment maintaining 22±2℃
• Warehousing selection must haveMedical device storage qualificationswarehouses
  • Independent storage area ≥200㎡
  • Equipped with dual-circuit power supply system

Closed-loop system for after-sales management

EstablishFull lifecycle traceability system:

• Completion within 7 working days after equipment installationFirst-operation documentation filing
• Maintenance records must include:
  • Temperature and humidity data for each maintenance
  • Traceable documentation for component replacements
• Adverse event reports must beWithin 72 hourssubmitted to drug regulatory authorities

Analysis of practical cases

When a Class III hospital imported 3.0T MRI equipment, due tomissing power adaptation certificateresulting in 13-day port detention. Solution:

• Emergency processing oftemporary power compatibility testing
• Coordinating with customs forbond release
• Subsequent submission of the EMC report for EU CE certification

This case demonstrates that a professional agency team can reduce the problem-solving cycle by more than 50% and decrease port demurrage losses by approximately 230,000 yuan.