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

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

• Qualificationsofoverseasmanufacturers
  • Medicaldeviceproductionlicenseofthecountryoforigin
  • ISO13485qualitysystemcertificationcertificate
  • Freesalecertificate(subjecttoHaguecertification)
• Qualifications of domestic agents
  • Medicaldevicebusinesslicense(includingauthority)
  • Qualitymanagementsystemcertificationcertificate
• Product access qualifications
  • Medicaldeviceregistrationcertificate(NMPAfilingcertificate)
  • Chinesetechnicalinstructionsandlabeldrafts

Specifications for preparing import declaration documents

Starting from 2025,the General Administration of Customs will put it into use.Intelligent Document Review System,Special attention should be paid to the declaration materials:

• Thecontractinvoicemustindicatethemedicaldeviceregistrationcertificatenumber
• TheattacheddocumentsmustincludeacompleteTechnicalparametercomparisontable
• DisinfectionequipmentneedstoprovideProofdocumentofsterilizationmethod
• DiagnosticreagentsmustbeaccompaniedbyCold-chaintransportationrecords

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

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

• Thepre-declarationstage
  • Completethepre-rulingofcommoditycodeclassificationinadvance
  • ConfirmwhethertheequipmentinvolvesCCCmandatorycertification.
• On - site inspection stage
  • MedicalelectricalequipmentneedstoundergoElectromagneticcompatibilitytesting
  • Forimplantablemedicaldevices,itisnecessarytoprovideBiocompatibilityreport
• Post-clearance management
  • Completetheuniqueidentification(UDI)ofimportedmedicaldevicesEstablishacompleteDeclaration
  • QualitytraceabilityfilePrecautionsforcustomsclearanceofspecialmedicalequipment

Differentiated treatment should be adopted for different types of equipment:

Large - scale imaging equipment

• :Itisnecessarytohandleinadvance:Exemptionfrompre-shipmentinspectionInvitrodiagnosticreagentsprocedures
• :Theremainingvalidityperiodshallnotbelessthan6months:Surgicalrobots
• :Itisnecessarytodeclareseparately:SoftwarecopyrightcertificateCustom-madedentures
• :Itmustbeaccompaniedbythepatients:OralmodeltestreportRegulationsforpost-importmarketmanagement

Regulations on the Supervision and Administration of Medical Devices in 2025

According toRegulations on the Supervision and Management of Medical Devices in 2025Electronic files of imported equipment

• Establish,Real-timeupdateandmaintenancerecordsAssistincompleting
• AssistincompletingAnnualQualityManagementSystemAudit
• SubmitregularlyAdverseEventMonitoringReport
• OrganizeClinicalUseTrainingAndkeeprecords

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 customs and Response time of after - sales serviceThree core indicators.