Medical EquipmentImport RepresentationThe Ice and Fire of the Market

The global medical device market size is projected to exceed $700 billion by 2025, with China being the second-largest import market.Medical EquipmentThe annual growth rate of imports has remained above 12%. However, data from the General Administration of Customs shows that in the past three years, medical...Equipment ImportsIn violation cases, 68% involve improper selection of agency service providers. When you hold a CT machine procurement contract, what kind of agency partner should you choose to truly safeguard your commercial interests?

Policy Trends in 2025

The latest revised "Regulations on the Supervision and Administration of Medical Devices" by the National Medical Products Administration clearly stipulates:

• The registration timeline for Class II devices has been shortened from 120 days to 90 days.
• Customs new additionsBiosafety testing moduleSpecial review
• The electronic verification system for import licenses has been fully launched.

The Three Golden Rules for Selecting Agents

• Qualification Matrix
  • Medical Device Business Filing Certificate (Check whether the scope of permission includes diagnostic equipment)
  • ISO 13485 Quality Management System Certification (2025 Edition with New Cybersecurity Requirements)
  • AEO Advanced Certification Enterprise Qualification (Verify the authenticity of the customs registration number)
• Service capabilities
  • FDA/CE certification update response speed (transition period for the new EU MDR regulations ends in 2025)
  • Cold Chain Transportation Temperature Control Record Traceability System
  • Emergency Response Case Database (e.g., Epidemic Control, Technical Trade Barriers)

A Warning Record of Typical Risk Cases

A company encountered customs clearance delays for imported ventilators in 2025:

• Fatal mistake:The agent failed to promptly update the FDA software security certification requirements.
• Chain reaction:The device's networking function was disabled, resulting in a customer claim of 3.8 million yuan.
• Solution path:Professional agents resolved the crisis through technical document amendments + localized adaptation solutions.

Four Steps to Identify High-Quality Agents

1. Please verify the customs clearance records for similar equipment imports over the past three years (provide screenshots of the customs data as required).
2. Conduct on-site inspections of customs system operational procedures (with a focus on the pre-classification review mechanism).
3. Request a demonstration of emergency scenario simulation (such as the response process for an FDA inspection).
4. Verify insurance coverage (recommended coverage amount not less than 150% of the cargo value).

When faced with an agent's promise of "all-inclusive service," be sure to verify whether their contingency plan includesResponse to Sudden Changes in Technical RegulationsandLocalization rectificationCapability. Remember, a truly professional medical equipment import agent always speaks through meticulous control capabilities.