Medicalspecial requirements

The import of medical equipment involvesa dual regulatory system,which must comply with the import management regulations of the General Administration of Customs and also meet the requirements of the National Medical Products AdministrationRegistration requirements.The latest "Classification Catalogue of Medical Devices" implemented in 2025 includes 23 types of products such as CT machines and ventilators under Class II supervision,which means that the agency agreement must be clear about this.Responsible party for handling registration certificatesandQuality Guarantee Clause.

Analysis of Core Clauses of the Agency Agreement

• DefinitionoftheScopeofAuthorization
  • Clarifyagencymatters:detailedauthoritiesforcustomsdeclaration,transportation,warehousing,anddocumenthandling
  • Limittheproductscope:name,modelofmedicaldevices,andthree-digitHScodelimitation
• Division of Customs Clearance Responsibilities
  • Obligationofdocumentreview:verificationresponsibilityfordocumentssuchasmedicaldeviceregistrationcertificatesandtestreports
  • Mechanismforsharingdemurragecharges:thesharingratioofportdetentionfeescausedbyincompletedocuments
• Malaysian importers often file claims on the grounds of “circuit board damage caused by excessive humidity”.Solutions:
  • Installmentpaymentmode:Usually,30%advancepayment+40%aftercustomsclearance+30%uponarrivalandinspectionareadopted.
  • Exchangeratefluctuationclause:clarifythattheexchangerateonthedateofcustomsacceptanceofthedeclarationisthesettlementbenchmark

Practical Key Points for Risk Prevention

The import case of a certain medical device company in 2025 shows that due to the lack of clarity in the agreement,the company encountered problems in importing the device.Responsibility for CE certification conversion29.the monitor worth 1.2 million US dollars was detained at the port for 28 days.It is recommended that the agreement must include:

• Clauseonthetimelinessofqualificationdocuments:monitoringmechanismforthevalidityperiodofregistrationcertificates
• Resolutionofcommodityclassificationdisputes:pre-classificationserviceisincludedinthescopeofagency
• Handlingofqualitydisputes:rulesforselectingthird-partytestinginstitutions

Suggestions for Additional Clauses of the Agreement

In view of the special storage requirements for medical equipment,it is recommended to addCold chain transportation clause:

• Configurationstandardfortemperaturemonitoringequipment
• Temperatureanomalyhandlingplanfortransportationdelays
• Responsibilityforkeepingbiosecuritycertificationdocuments

Strategy for Selecting Agency Services

By comparing the service agreements of 12 agency companies in the Yangtze River Delta region,it is found that the agreements of high - quality agents usually include:

• Pre-classificationaccuracyguaranteeclause(≥98%)
• WarehousingFilingCertificateforMedicalDevices
• WrittenCommitmentoftheCommunicationChanneloftheFoodandDrugAdministration

It is recommended that enterprises require the agency company to provide before signing the agreementImport cases of similar products in the past three years,with a focus on verifying its specific plans for handling customs inspections and drug regulatory sampling.A well-drafted agency agreement should serve as a "risk isolation wall" for the import of medical devices,rather than merely a simple service authorization letter.