I.Import policy adjustments and key points of consumables supervision in 2025

With the acceleration of the globalization of the medical and health industry,China’s supervision system for imported rehabilitation equipment and its supporting consumables continues to improve.The new version of the 2025 Catalogue of Medical Devices for Import and Export will come into effect on July 1,2025.After the implementation of the "Classification Catalog," 12 dynamic management entries have been added for Class III medical devices,with core components such as pressure sensors and motor function assessment modules for neurorehabilitation equipment being included in the key regulatory scope.

Special attention is required for the declaration of imported consumables:

• Consumablesandhostequipmentmustestablishacompletecorrespondingrelationshipcertification.
• Theone-timedeclarationquantityofconsumablesmustnotexceedthetheoreticalservicelifematchingvalueoftheequipment.
• Biocompatibleconsumablesmustprovidetheoriginalmanufacturer’ssterilizationprocessvalidationdocumentation.

II.Practical Guide to End-to-End Customs Clearance Procedures

Taking the import of consumables for a certain brand of lower limb rehabilitation robot as an example,the complete customs clearance process includes:

• Pre-classificationphase(3-5workingdays)
  • Doubleverificationofequipmenttechnicalparametersandconsumablematerials
  • AnalysisofApplicabilityofTariffPreferenceAgreements
• Declaration and customs clearance phase (7-10 working days)
  • MedicalDeviceRegistrationCertificateandConsumablesRelevanceCertification
  • DocumentonSpecialProcessingTechniquesforOriginCertification

III.Core Value Comparison of Professional Agency Services

High-quality proxy service providers should possess the following capability matrix:

• Riskpredictionsystems
  • TheupdatefrequencyoftheHScodedynamicdatabaseis≤24hours.
  • Theaccuracyrateofmedicaldeviceclassificationpre-judgment≥98%.
• Time Control Scheme
  • On-siteinspectionresponsetime≤2hours.
  • Theaverageprocessingtimefordocumentcorrectionsis≤1.5workingdays.

IV.Analysis of Risk Prevention and Control in Typical Cases

A rehabilitation center’s imported German gait trainer encountered document rejection:

• Thecruxoftheissue:Thesterilizationmethodforconsumablesdoesnotspecifytheirradiationdoseparameters.
• Solutionpath:
  • Coordinatewithoverseasmanufacturerstoissuenotarizeddocumentsofprocessdescriptions.
  • ApplicationfortheFast-TrackHealthQuarantineofSpecialItems
• Ultimately,it saved 11 working days in customs clearance time.

5.Industry trends and response suggestions for 2025

According to the latest statistics from the General Administration of Customs,rehabilitationThe annual growth rate remains within the range of 18%-22%,but the error rate in declarations has increased by 7.3% year-on-year.It is recommended that import enterprises:

• Establishaconsumablesbatchmanagementandtraceabilitysystem
• Selectanauthorizedagentserviceproviderwithspecializedqualificationsformedicaldeviceimports.
• Plantheconsumablesreplenishmentcycle6monthsinadvance.