China 2025Medical EquipmentNew trends in the import market

According to forecasts from Chinas General Administration of Customs, the import scale of medical devices in China will exceed 150 billion yuan in 2025, with high-end imaging equipment accounting for 35%. Under the latest revision of 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

Establishment of qualification review system:

• Accurate classification of products (Class II/III devices)
• Verification of overseas manufacturers GMP certification documents
  • Validation of FDA 510(k)/CE certification effectiveness
  • Compliance review of production sites
• Import RepresentationBusiness operation license filing

Technical points for customs declaration:

• Precision control of HS code classification
• Applicability analysis of tariff reduction policies
  • Free trade agreementIt is recommended to verify through the following methods:Optimization
  • Matching with major technical equipment import catalog
• Synchronized application for medical device registration certificates

Design of specialized logistics solutions

For the special attributes of medical equipment, professional agencies need to establish customized transportation systems:

• Implementation of anti-vibration packaging standards for precision instruments
• Parameter configuration of temperature-controlled transportation equipment
  • Temperature fluctuation control of ±2℃ for refrigeration equipment
  • Deployment of real-time monitoring systems
• Graded management of medical device dedicated warehouses

Fund risk management model

Professional agency services ensure fund safety through the following mechanisms:

• L/CClause risk screening
• Exchange rate fluctuation hedging solutions
  • Forward exchange settlement to lock in costs
  • Currency swap transaction configuration
• Tariff deposit estimation model

Clinical filing and post-sales traceability system

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

• Preparation of clinical trial filing data packages
• Integration with adverse event monitoring systems
  • Implementation specifications for UDI traceability codes
  • Annual Safety Report Compilation
• Cloud Management of Technical Maintenance Archives

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