Global HealthcareEquipment importEvolution of the Policy Landscape

In 2025, the global major medical device markets are showing a trend of tightening regulations. The General Administration of Customs of China's Announcement No. 63 will classify Category IIMedical devicesThe agency authorization period has been shortened to 14 months, with the EU's new MDR certification introducing a dynamic traceability mechanism, while the U.S. FDA has strengthened the application of the UDI (Unique Device Identification) system. According to data from the International Medical Device Regulators Forum, compliant agency services can reduce customs clearance time by 40% and lower the risk of administrative penalties by 25%.

Core Steps for Medical Equipment Agency Authorization

• Qualification verification stage
  • Verification of the Validity of Manufacturer's ISO 13485 System Certification
  • Verification of the Validity of Target Market Access Certificates (e.g., CE/FDA/CMDCAS)
• Preparation of Legal Documents
  • Notarization and Authentication Dual Requirements for Power of Attorney
  • Professional Verification of Product Technical Documentation Translation
• Customs clearance practical operations
  • HS Code Classification Accuracy Dual Verification Mechanism
  • Compliance Review of Special Packaging Requirements

Comparative Analysis of Regional Regulatory Differences (2025 Edition)

Typical Risk Avoidance Plan

A case of importing German CT equipment shows that the agency company achieved...Pre - classification dispute resolution mechanism, the equipment originally classified under item 9022.14 has been successfully reclassified under item 9018.90, resulting in a tariff difference of 7.2%. Practical recommendations for operation include:

• Establish a dynamic regulatory monitoring system (updated monthly).
• Adopt a dual-track document management system (paper + blockchain notarization).
• Implement a pre-clearance simulation audit mechanism.

Key indicators for agency service selection

Qualified agency companies should possess:

• Medical Device Dedicated Service Team (recommended with over 5 years of industry experience)
• Customs AEO Advanced Certification qualification
• Major Port Emergency Response Network (4-hour On-Site Commitment)
• Successfully handled ≥20 cases of filing changes for Class II medical devices.

In 2025, the medical equipment import sector is witnessing a trend of regulatory and technological convergence, with China Customs piloting the application ofIntelligent Classification Assistance SystemThe product classification accuracy can be improved to 98.7%. It is recommended that importers pay special attention to the authorization documents in theQuality Traceability Clause, to avoid customs clearance delays caused by unclear division of supply chain responsibilities.