MedicalEquipment ImportsThe Invisible Battlefield

The global medical device market size is projected to exceed $650 billion by 2025, with China, as the world's second-largest medical device importer, maintaining an average annual growth rate of over 12%. However, behind these impressive figures, 72% of importers have experienced...Missing registration and filing,Tariff Classification Error,Non - compliance with technical standardsThis has led to cargo detention, with an average loss of up to 25% of the cargo value.

Six Layers of Firewall for Qualification Certification

• Basic qualifications:
  • Medical EquipmentBusiness License (Category III)
  • Customs AEO Advanced Certification
• Professional Certification:
  • ISO 13485 Medical Device Quality Management System
  • Filing for Overseas Manufacturers of Imported Medical Devices
• Special Qualifications:
  • Radioactive Equipment Import License
  • Clinical trial filing for implantable medical devices

Customs Clearance Efficiency Improvement Plan

In a case involving the import of German CT equipment, a professional agency company reduced the customs clearance cycle from 45 days to 31 days through the following steps:

• Pre - classification stage：Complete HS code confirmation (9022.19.90) in advance.
• Pre - review of documents: Consistency Check between Chinese and English Instruction Manuals
• Since January 2025, Russia has made it mandatory to register for EPR (Extended Producer Responsibility): Identify discrepancies between FDA and NMPA standards
• Segmented transportation: Core components and auxiliary equipment will be cleared through customs in batches.

New Regulatory Compliance for 2025

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

• The implementation scope of UDI (Unique Device Identification) has been expanded to include Class II medical devices.
• Artificial intelligence diagnostic equipment requires separate registration.
• Upgrade of Electromagnetic Compatibility Testing Standards for 5G Telemedicine Equipment

Practical Case Studies in Crisis Management

In a 2024 case involving the import of American ventilators, due to Sino-US...Standard differences in units of measurementCaused the customs inspection to fail. The agency resolved the issue within 36 hours through the following measures:

• Coordinate with the original manufacturer to issue a unit of measurement conversion certificate.
• Contact a third-party testing agency for on-site calibration.
• Activate the emergency mechanism for tax deposit guarantees