New trends of policies for importing laboratory equipment in 2025

With theMedical EquipmentThe 2025 Edition of the Classification Catalogue is officially implemented, laboratoryEquipment ImportsThe regulatory system presents three major changes:Refinement of equipment classification,Standardization of declaration documentsandStrengthening of quality traceabilityAmong them, 23 types of equipment such as PCR instruments and biosafety cabinets have new dynamic supervision requirements. Importers need to pay special attention to the continuation conditions of the tax - free policy for scientific research equipment in Announcement No. 89 of the General Administration of Customs.

Panoramic Analysis of Core Agency Qualifications

CompliantImport RepresentationService providers must possess the following qualification matrix simultaneously:

• Business Qualification Category
  • Medical Device Business Filing Certificate (Applicable to Class II Equipment)
  • import and exportRegistration Certificate for Consignors and Consignees of Goods
• Customs Clearance Ability Category
  • AEO (Authorized Economic Operator) Advanced Certification qualification from customs
  • Qualification Accreditation of Commodity Inspection Institutions (CMA)
• Industry Access Category
  • Filing Certificate for the Construction of Biosafety Laboratories
  • Approval Form for the Entry and Exit Health Quarantine of Special Articles

Golden Rules for Selecting Agent Companies

When choosing an import service provider, six dimensions should be focused on:

• Completeness of Qualifications: Verify the validity period of the qualification certificates and the covered product categories
• Industry experience level: Request to provide import cases of similar equipment in the past three years
• Customs Affairs Handling Ability: Confirm the accuracy of pre - classification and the compliance review system
• Logistics Compatibility: For special equipment, it is necessary to verify the qualification for temperature - controlled transportation
• After - sales Service Chain: Include value - added service capabilities such as equipment installation and commissioning
• Risk Control Mechanism: Have a complete quality traceability and emergency response plan

Typical issue response strategies

Provide solutions for common business scenarios:

• Problem of Equipment Stagnation at the Port: Handle the electronic pre - review of the Entry Goods Customs Clearance Form in advance
• Rejection of Tax - free Application: Improve the attachment materials of the Commitment Letter for the Use of Scientific Research Equipment
• Dispute over Model Certification: Prepare EU CE or US FDA equivalent certification documents
• Import and disassembly of parts: Indicate the associated code of the complete set of equipment when declaring

List of declaration documents in 2025

According to the latest regulatory requirements, the necessary documents include:

• EquipmentIt is recommended to verify through the following methods:Certificate (to be authenticated by the embassy)
• Declaration of Conformity (including electromagnetic compatibility test report)
• Classification and identification report of hazardous characteristics (applicable to equipment such as centrifuges)
• Electronic copy of Automatic Import License (License O)

Compliance risk warning

The recent regulatory focus is on:Refurbishment markings for used equipment,Compatibility between software version and hardware,Proportion of accompanying consumablesThree aspects. It is recommended to clarify the suppliers liability clauses at the contract - signing stage, reserve 10% of the balance as a quality guarantee, and stipulate that the relevant clauses of the United Nations Convention on Contracts for the International Sale of Goods shall apply to dispute resolution.