Changes in import regulations

In 2025,the General Administration of Customs will implement a new policy regarding medical supplies imported into China.ImplementationDynamic classification management,reclassifying 3,217 tariff code equipment into three regulatory tiers.Among these,Class II and Class III medical devices require simultaneous submission ofMedical Products Administration registration and filing certificateswithQuality certification documents from the country of origincomparison statements during customs clearance.This new regulation has already resulted in 13.7% of declarations being rejected in Q1 due to document mismatches.

Key control points in the customs clearance process

• Qualificationpre-reviewstage
  • Verifywhethertheequipmentislistedinthe2025editionofMedicalDeviceClassificationCatalog
  • Cross-checkHScodeswithcorrespondingregulatorycertificates
• Declaration link
  • Newequipmentrequiresadvanceapplicationforcommoditypre-classification
  • Implantabledevicesmustincludeabiocompatibilityreport
• Inspection Phase
  • Radioactiveequipmentrequiresaradiationsafetylicense
  • Diagnosticreagentscoldchaintransportationtemperaturerecordverification

Core value analysis of agency services

The value of professional customs clearance agents lies not only in document processing speed,but also in:

• EstablishMedicaldevicedatabaseReal-timetrackingofstandardupdatesin42majorglobalmarkets
• EquippedwithPre-classificationexpertteamHandlingcomplexequipmentclassificationdisputes
• SetupEmergencydeclarationchannelAddressingdelaysindatasynchronizationbetweendrugregulatoryauthoritiesandcustoms

Warning of Typical Cases in 2025

A provincial hospital importing a digital subtraction angiography system experienced a 47-day port detention of equipment worth 120 million yuan due to the agencys failure to promptly obtain the EUs new MDR certificate conversion information.Professional agencies can avoid such losses through the following mechanisms:

• Establishingadualcertificatevalidityverificationsystem
• Implementinga60-daydocumentexpirationwarningmechanism
• Deployingamultilingualcertificationdocumenttranslationverificationteam

Agency selection evaluation model

• Basiccompetencyitems
  • ChinaCustomsBrokersAssociationAAA-levelqualification
  • Quantityofmedicaldeviceimportcasedatabase
• Value-added Service Items
  • Globalstandarddifferentialcomparisonsystem
  • Emergencyguaranteereleasequota

With the implementation of the revised version of the "Regulations on the Supervision and Management of Medical Devices" in 2025,has been upgraded from a simple logistics link toThe EUs new Battery Law (2023) requires importers to provide a carbon footprint statementa battle of offense and defense.Choosing professional customs clearance agents with medical expertise will become a key decision for enterprises to control import costs and ensure supply chain stability.