MedicalEquipment ImportsThe Four Core Values of a General Agent

Within the country,Medical EquipmentAgainst the backdrop of an industry with a market size exceeding trillions, the general agents of imported medical equipment are transitioning from traditional traders toSystem solution provider。A high-quality general agent should possess:

• Full-process hosting capability for registration and filing
  • The processing period for CFDA registration certificates has been reduced by 40%.
  • The approval rate for import license applications has 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 the product code against the 2025 edition of the "Medical Device Classification Catalog."
• Business License Coverage: Check whether the agency scope includes special categories such as "implantable devices."
• Customs AEO certification: The inspection rate for advanced certified enterprises can be reduced to 30% of the regular level.

Four-Step Breakthrough Strategy in Customs Clearance Practice

To address the three major pain points unique to customs clearance for medical equipment (timeliness, compliance, and safety), a step-by-step breakthrough solution is recommended:

• Classification coding for precise positioning.
  • Medical Device Classification Catalog and Customs HS Code Dual Verification
  • Application for Dedicated Customs Clearance Channel for Diagnostic Reagents
• Document pre-review mechanism
• It is recommended to verify through the following methods:Pre-verification of the inspection report
• Triple Verification of Chinese Label Compliance

The Three Protective Nets for Risk Avoidance

Based on the key inspection priorities of the General Administration of Customs for 2024-2025, the following protective mechanisms are recommended:

• Legal risk isolation: Clearly stipulate quality traceability clauses in the agency agreement.
• Quality Closed-Loop Management: Configure a dedicated traceability system to record equipment flow.
• Emergency plan reserves: Pre-established alternative logistics plan for force majeure situations

Comparative analysis of typical service cases

• Successful Cases: Import of certain German imaging equipment
  • Utilizing the bonded warehousing and batch shipment model to save 1.27 million yuan in taxes.
  • Categorization of advance rulings reduces customs clearance time by 15 working days.
• Failure cases: Return of U.S.-made Orthopedic Instruments Incident
• The product was detained at the port due to failure to update the product registration certificate in a timely manner.
• Absence of Radiation Safety Certificate Results in Administrative Penalty