MedicalEquipment ImportsQualification access standards

According to the1. VerifyMedical EquipmentClassification Catalog (Revised Edition), importers must pay special attention to three types of changes:

• 7 new Class II controlled varieties added for diagnostic reagents
• Imaging equipment resolution standards upgraded to 0.3mm
• Additional biocompatibility testing requirements for implantable devices

Three core documents must be completed during the qualification preparation stage:

• Verification of validity period for Imported Medical Device Registration Certificate,
  • Remaining validity period of registration certificate must exceed 6 months
  • Completeness verification of attached technical evaluation reports
• ManufacturerISO 13485 certificationDocument notarization
• Import RepresentationFiling of Medical Device Business License

Key points of customs clearance operations

Customs will implement new inspection rules for medical equipment in 2025:

• 100% unpacking inspection for equipment with unit price exceeding $200,000
• Equipment containing radioactive components requiresRadiation Safety License
• AI diagnostic equipment requires supplementary algorithm source code filing

Special attention required during customs clearance:

• HS Code confirmation
  • Medical ultrasound equipment classified under 9018.1210 rather than general electronic equipment
  • Matching reagents need to be declared separately under pharmaceutical tariff codes
• Inspection and quarantine documents
  • Sterilization equipment requires accompanying foreign official health certificates
  • Equipment containing biological materials requiresspecial article approval certificates

Special equipment logistics management standards

Considering the special nature of medical equipment, a three-level logistics guarantee system must be established:

• Temperature-controlled equipment transportation standards
  • MRI superconducting coils maintaining -269℃ liquid helium environment
  • In vitro diagnostic reagents require 2-8℃ cold chain monitoring throughout transportation
• Shockproof Packaging Certification
  • CT machine gyroscope transportation must pass ISTA 3E testing
  • Special cushioning materials for surgical robot joint parts

Key points of post-sales compliance management

Legal procedures required after equipment delivery:

• Complete Imported Medical Device Usage Registration within 30 days
• Adverse event monitoring report during first year of use
• Annual cybersecurity self-inspection filing for software-based equipment

Recommendations based on frequent typical cases in recent years:

• Avoid declaring medical equipment under trading company names
• Refurbished used equipment imports require advance processingMedical device re-registration
• Clinical trial equipment separate application for temporary import permit