Enter in 2025口SupervisionNew動Submit to

According to the "Regulations on the Import Supervision of Medical Devices" recently issued by the General Administration of Customs in 2025,the third-class medical devices will be subject to an electronic traceability code management system.The new regulations require import enterprises to complete the registration of product traceability information 72 hours before the goods arrive at the port,which poses a major challenge to the traditional customs clearance model.It is worth noting that the medical devicesThe error rate in declarations has increased by 23% year-on-year compared to last year,primarily concentrated in two major issues: incorrect product classification (58%) and expired health permits (32%).

Four core values of professional agency services

• Real-timeTrackingofRegulatoryUpdates
  • TimelyInterpretationofNMPAClassificationCatalogAdjustments
  • AnticipatetheimpactofchangesinEUMDRandFDA510(k)certification.
• Technical Document Compliance Review
  • StandardizedProductionofChinese-EnglishInstructionManuals
  • SupplementandimprovetheISO13485systemdocumentation.
• Special customs clearance channel established
  • Tax-freeapprovalchannelforscientificresearchequipment
  • EmergencyMedicalSuppliesRapidCustomsClearancePlan
• Risk Early - Warning System
  • HSCodeChangeAlert(23NewMedicalDeviceSubheadingsAddedinthe2025Edition)
  • Conductcompliancescreening.

Analysis of Key Nodes in the Entire Customs Clearance Process

Taking the import of a 3.0T MRI device by a certain enterprise as an example,professional agency services cover the following key steps:

• AccessPredictionStage
  • Confirmwhethertheequipmentislistedinthe"ProhibitedImportMedicalDeviceCatalog."
  • VerifythecorrespondencebetweenCEcertificationanddomesticregistrationcertificate
• Document preparation stage
  • Assistinobtainingmedicaldeviceregistrationcertificates(savinganaverageof14workingdays)
  • PreparetechnicaldocumentationcompliantwithGB9706.1-2025.
• On-site clearance phase
  • Coordinatewithlocalcustomstoconductdestinationinspections.
  • HandlingsupplementarymaterialsforEMCtestreports

Chronicles of Typical Risk Cases: Lessons Learned

An importer failed to recognize the adjustments in the new edition of the "Medical Device Classification Catalog," mistakenly declaring a Class II ultrasound diagnostic device under code 6803.0010,resulting in:

• Thecustomsclearancedelayof23daysresultedindemurragechargesof120,000yuan.
• Subsequentprocessingoftheimportlicensetook42days.
• Facingapenaltyfor30%misdeclarationofthecargovalue.

Three Major Avoidable Mistakes That Professional Early Intervention Agents Can Prevent:

• NeglectingtheAnnouncementofClassificationandDefinitionResultsbytheDrugAdministration
• Usingoutdatedproductsafetystandards
• TheChineselabeldoesnotindicatethemedicaldeviceregistrationcertificatenumber.

2025 Agency Services Selection Guide

• Essentialqualificationverification
  • MedicalDeviceFilingAgencyQualificationCertificate
  • AEO(AuthorizedEconomicOperator)AdvancedCertification
• Verification of service capabilities
  • Importcasesofsimilarequipmentinthepastthreeyears.
  • OverseasTechnicalDocumentationTranslationTeamConfiguration
• Emergency response mechanism
  • Portemergencyinspectionrapidresponsetime
  • TechnicalReviewNonconformityRectificationPlan

Special Tips: The "Rules for the Unique Identification System of Medical Devices",which came into effect in January 2025,require that high-risk products such as imported heart stents be registered with UDI data six months in advance.It is recommended that enterprises explicitly stipulate in their procurement contracts that suppliers must provide UDI labels that comply with Chinese standards,to avoid incurring label modification costs after the products arrive.