China in 2025Medical EquipmentNew Trends in the Import Market

According to forecasts by the General Administration of Customs of China, the import scale of medical devices in China will exceed 150 billion yuan by 2025, with high-end imaging equipment accounting for 35%. Against the backdrop of the latest revisions to the "Regulations on the Supervision and Administration of Medical Devices," professional agency services have become an essential choice for enterprises to mitigate risks.

Analysis of Core Service Modules for Medical Equipment Agency

Construction of Qualification Review System:

• Accurate Classification of Products (Class II/III Medical Devices)
• Verification of GMP Certification Documents for Overseas Manufacturers
  • Validation of FDA 510(k)/CE Certification Effectiveness
  • Production Site Compliance Review
• Import RepresentationBusiness Operation License Filing

Key Technical Points for Customs Clearance Declaration:

• HS Code Classification Accuracy Control
• Applicability analysis of tariff reduction policies
  • Free trade agreementIt is recommended to verify through the following methods:Optimization
  • Matching of Major Technical Equipment Import Catalog
• Synchronized Submission of Medical Device Registration Certificate

Special logistics solution design

To address the unique attributes of medical equipment, professional agents must establish a customized transportation system:

• Implementation standards for shockproof packaging of precision instruments
• Parameter Configuration of Temperature-Controlled Transport Equipment
  • The temperature fluctuation of refrigeration equipment is controlled within ±2℃.
  • Real-time monitoring system deployment
• Graded Management of Dedicated Medical Device Warehouses

Fund Risk Management Model

Professional agency services ensure fund security through the following mechanisms:

• L/CClause Risk Screening
• Exchange rate fluctuation hedging solutions
  • Forward exchange settlement and sale to lock in costs
  • Currency Swap Transaction Configuration
• Estimated Model for Tariff Deposit

Clinical Filing and Post-Market Traceability System

According to the 2025 revised "Measures for the Supervision and Administration of the Quality of Medical Device Use," agency services must extend to:

• Preparation of Clinical Trial Filing Data Package
• Access to the Adverse Event Monitoring System
  • Implementation Specifications for UDI Traceability Codes
  • Annual Safety Report Compilation
• Technical Maintenance Archives Cloud Management

A 2024 case study of importing a linear accelerator by a top-tier hospital demonstrated that professional agency services reduced the equipment commissioning cycle by 40 days and lowered overall costs by 23%. Against the backdrop of increasingly stringent compliance requirements for medical device imports, selecting professional agencies with Medical Device Business Filing Certificates and AEO Advanced Certification has become a core strategy for enterprises to mitigate operational risks.