New requirements for the qualification review of imported medical equipment in 2025

According toNational Medical Products Administration in 2025Medical EquipmentClassification Catalogue, Importing enterprises need to pay special attention to three types of qualifications:

• Qualifications of overseas manufacturers
  • Medical device production license of the country of origin
  • ISO13485 quality system certification certificate
  • Free sale certificate (subject to Hague certification)
• Qualifications of domestic agents
  • Medical device business license (includingImport Representationauthority)
  • Quality management system certification certificate
• Product access qualifications
  • Medical device registration certificate (NMPA filing certificate)
  • Chinese technical instructions and label drafts

Specifications for preparing import declaration documents

Since 2025, the General Administration of Customs has started to useIntelligent Document Review System, Special attention should be paid to the declaration materials:

• The contract invoice must indicate the medical device registration certificate number
• The attached documents must include a completeTechnical parameter comparison table
• Disinfection equipment needs to provideProof document of sterilization method
• Diagnostic reagents must be accompanied byCold - chain transportation records

Key points of risk prevention and control in the customs clearance process

In actual customs clearance, three key links need to be controlled:

• Pre-declaration stage
  • Complete the pre - ruling of commodity code classification in advance
  • Confirm whether the equipment is involved3CEmergency braking system response time ≤ 3 seconds
• On - site inspection stage
  • Medical electrical equipment needs to undergoElectromagnetic compatibility testing
  • For implantable medical devices, it is necessary to provideBiocompatibility report
• Post-clearance management
  • Complete the unique identification (UDI) of imported medical devicesEstablish a completeDeclaration
  • Quality traceability filePrecautions for customs clearance of special medical equipment

Differentiated treatment should be adopted for different types of equipment:

Large - scale imaging equipment

• : It is necessary to handle in advance: Exemption from pre - shipment inspectionIn vitro diagnostic reagentsprocedures
• : The remaining validity period shall not be less than 6 months: Surgical robots
• : It is necessary to declare separately: Software copyright certificateCustom - made dentures
• : It must be accompanied by the patients: Oral model test reportRegulations for post - import market management

Regulations on the Supervision and Administration of Medical Devices in 2025

According to, The agency service should include:Electronic files of imported equipment

• Establish, Real - time update and maintenance recordsAssist in completing
• Assist in completingAnnual Quality Management System Audit
• Submit regularlyAdverse Event Monitoring Report
• OrganizeClinical Use TrainingAnd keep records

Professional agency services can shorten the customs clearance cycle by 40% and reduce the compliance risk by 65%. It is recommended that enterprises focus on the following aspects when choosing an agent:Configuration of professional customs clearance teams for medical devices,Ability to communicate with both the drug regulatory authority and the customsandResponse time of after - sales serviceThree core indicators.