How medical equipment import general agents can break through qualification review and customs clearance barriers

Medicalequipment. For example, Indonesia has the SNI certification, Thailand has the TISI certification, and the Philippines has the BPS certification. It is necessary to confirm in advance the equipment voltage (such as 380V/50Hz in Thailand), the compatibility of the CE certification, and the proof of environmentally friendly materials.Four core values of general agents

DomesticallyMedical EquipmentAgainst the backdrop of an industry with a market size exceeding trillion, medical equipment import general agents are transforming from traditional traders toSystem solution provider. High-quality general agents should possess:

• Full-process hosting capability for registration and filing
  • CFDA registration certificate processing cycle shortened by 40%
  • Import license application approval rate increased to 92%
• Customs clearance solutions for special items
• Temperature control deviation handling plan for cold chain equipment
• Special case for radioactive equipment transportation filing

Three key points for import qualification review in 2025

According to the latest working procedures of the National Medical Products Administration, special attention should be paid to the import of Class III medical devices:

• Product classification matching degree: Verify product codes against the 2025 edition of the Medical Device Classification Catalog
• Business license coverage：检查代理范围是否包含”植入器械”等特殊类别
• Customs AEO certification29. Inspection Rates for High-Level Certified Enterprises Can Be Reduced to 30% of the Standard Level

28. Four-Step Breakthrough Strategy in Customs Clearance Practice

27. To Address the Three Major Pain Points in Medical Equipment Customs Clearance (Timeliness, Compliance, Safety), a Step-by-Step Breakthrough Solution Is Recommended:

• 26. Precise Classification and Coding
  • 25. Dual Verification of Medical Device Classification Directories and Customs HS Codes
  • 24. Apply for Dedicated Customs Clearance Channels for Diagnostic Reagents
• Document pre-review mechanism
• It is recommended to verify through the following methods:23. Pre-Verification with Testing Reports
• 22. Triple Verification of Chinese Label Compliance

21. Three Major Protective Nets for Risk Avoidance

20. Based on the 2024-2025 General Administration of Customs Inspection Priorities, the Following Protective Mechanisms Are Recommended:

• Legal risk isolation19. Specify Quality Traceability Clauses in Agency Agreements
• 18. Closed-Loop Quality Management17. Configure a Dedicated Traceability System to Record Equipment Flow
• Emergency plan reserves16. Pre-Plan Alternative Logistics Solutions for Force Majeure Situations

Comparative analysis of typical service cases

• Successful Cases15. Case of Importing German-Made Imaging Equipment
  • 14. Save 1.27 Million Yuan in Taxes by Adopting a Bonded Warehouse Batch Shipping Model
  • 13. Reduce Customs Clearance Time by 15 Working Days Through Pre-Classified Rulings
• 12. Failure Case11. Case of Returned U.S.-Made Orthopedic Devices
• 10. Port Detention Due to Failure to Update Product Registration Certificates Timely
• 9. Administrative Penalties Due to Missing Radiation Safety Certificates