欧盟企业在中国建议书（2024-2025）医疗器械工作组（英文）

Europeanchamber中国欧盟商会

HealthcareEquipmentWorkingGroup

KeyRecommendations

1.HarmoniseNamingRequirementsforMedicalDevices

•EstablishamechanismbetweentheNationalMedicalProductsAssociation(NMPA),theNationalHealthcareSecurityAdministration(NHSA)andtheNationalHealthCommission(NHC)toensureunifiednamingrequirementsformedicaldeviceproducts.

•Grantmanufacturerstheautonomytonametheirregisteredproducts,providedtheymeettherequirementsofboththemedicalproductsadministrationauthorityandthemarketaccessprocess.

SectionThree:Goods

•ConsidertheNMPA’sclassificationandnamingguidelinesformedicaldeviceswhenformulatingmarketaccess-relatedregulations,includingmedicalservicepricecatalogues,medicalserviceitemsandmedicalinsurancerulesfornaminggenericitems.

•Establishalinkbetweenthenamesofapprovedmedicalproductsandtheircorrespondingdesignationsinmedicalserviceitemstostreamlinetheproduct’smarketaccessprocess.

•Standardisehospitalserviceitemsandmedicalservicepricecataloguesnationwide.

2.EliminateUnfairCompetition,SpecificallytheTendencyofPublic

HospitalstoFavourDomesticProductsinProcurementProceduresandtheChallengetoIntellectualPropertyRights(IPR)

•Promoteahighlevelofopenness,treatdomesticandmultinationalenterprisesequally,andensurethatmedicalinstitutionscansmoothlybringtomarketinnovativemedicaltechnologyandproductsthatmeetthegrowingdemandsofscientificresearchandclinicalrequirements.

•RevisetheAuditingGuidelinesforGovernmentProcurementofImportedProducts(2021Edition)attheearliestopportunityandtakeindustryopinionsfullyintoaccount.

•Seekbroadsuggestionsfromclinicalandrelatedindustryassociations,includingforeign-investedenterprises,whendefining‘domesticallyproducedproducts’and‘domesticproducts’.

•Establishapatentlinkagesystemformedicalconsumables,similartoadrugpatentlinkagesystem.

•Establishavolume-basedprocurement(VBP)pre-investigationperiodformedicalconsumablesduringtheoppositionandwaitingperiodsofalawsuit,whilecreatingacommunicationchannelformedicalconsumablemanufacturerstoraiselegitimatecomplaintsrelatedtoanyIPR-issuesencounteredduringVBP.

3.RefineMarketAccessProcedurestoEncourageInnovativeTreatmentApproaches,EnhancetheApprovalMechanismforIncludingInnovativeTechnologiesinMedicalServiceCataloguesandMedicalInsuranceCatalogues,andProvideaClearDefinitionof‘InnovativeMedicalTechnologies/Devices’AcceptedbytheRelevantAuthorities

•Developasystemforclearlydefininginnovativetechnologies/productsalongwithrelevant

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guidelinestoclarifytheoverallreviewprocess,reviewfrequency,timelineandparticipatingparties.

•Acceleratetheestablishmentofadynamicmechanismforadjustingtheclassification,codeandgenericnameofmedicalconsumables—particularlyinnovativeproducts—withinthehealthinsurancesystemtooptimisetheprocessforincludinginnovativemedicalconsumablesinmedicalservicescatalogues.

•EstablishanexpertevaluationmechanisminVBPtoclearlydistinguishbetweenstandardmedicaldevicesandthosethatareconsideredtechnologicallyadvanced,anddeveloprulesthatencourageinnovationandlong-termindustrygrowth.

•Acceleratetheapprovalofnewinnovativemedicalservicepricingitemswiththecreationofatransparentcommunicationmechanism.

•EstablishagreenchannelsystemformedicalservicepricingitemsthathavebeenapprovedbytheNHSA,toacceleratetheprocesswhenotherprovincesapplyforthesamemedicalservicesitems.

SectionThree:Goods

4.ContinuetoAdvancetheDevelopmentofRegulatoryScienceandRegulatory

Innovation

4.1OptimisetheRequirementforRegistrationModification

•Implementaregulationthatadequatelyresolvesissuesrelatedtothesplittingofregistrationcertificates,definingsignificantchangesandsimplifyingtheprocessofupdatingmultiplecertificateswiththesameinformation.

•Establishaspecialnotificationchannelformodificationsduetoproductrecallstoincreaseproductsafety.

•GrantatransitionalperiodforimplementingproductchangesfollowingNMPAapprovalofregistrationmodifications.

4.2AcceleratethePromulgationoftheMedicalDeviceAdministrationLawand

RemovetheRequirementforCountryofOrigin(CoO)CertificationinPre-MarketApprovals

•RemovetherequirementforCoOcertificationasapreconditionfortheregistrationandfilingofimportedmedicaldevices.

4.3PermitEndUserstoExtendtheUseofActiveDeviceProductsThatHaveBeen

UtilisedBeyondTheir‘ExpectedServiceLife’BasedonRegularEvaluationsoftheDevice’sStatus,PerformanceandMaintenanceRecords

•Expandthedefinitionof‘expectedservicelife’(ESL)foractivemedicaldevicesinallrelevantregulations,andensurethisisunderstoodbytheregulatoryauthoritiesatalllevels.

•ClarifythatutilisinganactivedevicebeyonditsESLdoesnotequatetousinganexpiredproduct.

•Increasetheenduser’scapacitytoreasonablyevaluateanddynamicallyextendtheactualservicelifeofin-usedevices.

5.PromoteMarketAccessforHigh-precisionandInnovativeIn-vitroDiagnostics

(IVDs)

5.1ReflectIVD’sTechnicalFeaturesinbothVBPandMedicalTreatmentPricing

Catalogues

•Includedifferentdiagnosismethodsandtechnologiesinprocurementcatalogues,and

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purchaseaccordingtotheclinicaldemandfordifferenttechnicalfeaturesofIVDproductsanddifferentdiagnosismethods.

•EnsurethatonlyvalidatedreagentsareusedwithIVDdevices.1

•AdvancetheseparationofpricesformedicalconsumablesfrommedicalservicesinIVD,basedonthequalityofclinicaldiagnosisandtreatment,andscientificallygaugethecostofmedicalitems.

•EvaluateinacomprehensivefashiontheuniquecharacteristicsofIVDproductstofindasuitablepricemanagementmethodfortheimplementationofVBP.

5.2ShapeaRationalIVDReagentRegulatoryEnvironment

•FormulatecriteriaforacceptanceofclinicalevidenceofIVDreagentsintheregistrationprocess.

•DecreasethescopeofissuesthatmustbespecifiedduringtheregistrationofIVDreagents.

•Providesuitabletransitionperiodsfortheimplementationofguidingprinciplesthathavesignificantchangesorimplications,suchasthoserelatedtostabilitystudies.

5.3Phaseoutthe‘Two-invoiceSystem’

SectionThree:Goods

•RefrainfromdesignatingthesupplyofreagentsfrommanufacturerstoIVDequipmentmanufacturersasthe‘firstinvoice’.

•RefrainfromdesignatingtransactionsbetweentradingcompaniesandmanufacturerswithinthesamegroupinChina,orbetweenforeign-investedtradingcompaniesinChinaanddomesticmanufacturerswithwhichtheyhaveinvestedandcooperated,asoneinvoiceunderthe‘twoinvoicesystem’.

•Avoidmandatingashiftfromexperienceddistributorstolocalfirms,andallowIVDmanufacturerstoselectthevendorthatprovidesthemostappropriatelevelofservice.

RecentDevelopments

TheStateCouncilemphasisedtheimportanceofthemedicaldeviceandpharmaceuticalindustrieswiththeAugust2023approvalofactionplansforhigh-qualitydevelopmentinthesesectorsfrom2023to2025.2Thiswasreinforcedduringthesecondsessionofthe14thNationalPeople’sCongress,whenPremierLiQiangstressedthenecessityofenhancingmedicalandhealthservicecapabilitiesduringhispresentationoftheGovernmentWorkReport.3Thiswouldinclude

1Reagentsaresubstancesorcompoundsutilisedtoinstigateachemicalreactionortoverifyifareactionhasoccurred.Reagentsaretypicallydesignedtoreacttospecificbiomarkersorsubstancesinapatient'ssample,yieldingaquantifiableresult.Thetestingprocedurescanvarybasedonthedeviceandthetypeoftest.However,theygenerallyinvolveexposingthesampletothereagentandobservingtheensuingreaction,whichthedevicethenanalyses.Thesereactionsrepresentcertainbiologicalinteractionsorprocesses,enablingthedevicetoprovidecrucialdiagnosticdata.

2StateCouncilApprovesActionPlanforHigh-QualityDevelopmentofthePharmaceuticalsIndustry(2023-2025)AmongOtherProposals,Xinhua,25thAugust2023,viewed23rdApril2024,<

/xwdt/szyw/

art/2023/art_8ec3bf30ffb7467ca114e67406a9f925.html

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3GovernmentWorkReport,Xinhua,12thMarch2024,viewed23rdApril2024,<

/yaowen/liebiao/202403/content_6939153.htm

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coordinatingthedevelopmentandmanagementofmedicalinsurance,treatmentandmedicine,alongwiththereinforcementofoversightovermedicalinsurancefundusage.On13thMarch2024,theStateCouncilissuedtheActionPlantoPromoteLarge-scaleEquipmentRenewalsandTrade-insofConsumerGoods,whichmandatesa25percentincreaseinequipmentinvestment,includinginthefieldofmedicaldevices,by2027.4However,itdoesnotprovidespecificdetailsonwhoshouldcarryoutthismandateorhowitshouldbeaccomplished.

DespiteChina’seffortstoenhancethebusinessenvironmentandattractforeigninvestment,suchasthroughtheStateCouncil’sOpinionsonFurtherOptimisingtheForeignInvestmentEnvironmentandStrengtheningtheAttractionofForeignInvestmentanditsActionPlantoPromoteHigh-levelOpening-

4ActionPlantoPromoteLarge-scaleEquipmentRenewalsandTrade-insofConsumerGoods,StateCouncil,13thMarch2024,viewed23rdApril2024,<

/zhengce/content/202403/content_6939232.htm

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upandAttractForeignInvestment,5&6marketaccessrestrictionsonimportedmedicaldeviceproductsremainasignificantissue.AccordingtotheEuropeanChamber’sBusinessConfidenceSurvey2024,91percentofsurveyedmedicaldevicecompaniesreportedlostbusinessopportunitiesinChinaduetotheseconstraints.7

TheNationalHealthcareSecurityAdministration(NHSA)continuedtopromotecentralisedvolume-basedprocurement(VBP)toreducemedicalcostsin2023.8Thisapproachhasledtoanaveragepricereductionof70percentforvariousmedicalitems.TheNHSAalsostandardised116casesinwhichpricesdifferedforthesameproductsacrossdifferentprovinces,forbothdrugsandmedicalconsumables.In2024,theNHSAplanstoexpandandimprovecentralisedprocurement,aimingforatotalofatleast500nationalandprovincialVBPsofdrugsandmedicalconsumables.

InresponsetothepotentialimpactofVBPpolicies—includingdiminishedprofitsandlossofmarketshare—onmedicaldevicecompanies’researchanddevelopment(R&D),Chinaputinplacepoliciesaimedatencouraginginnovationinthesector.9TheseincludetheImplementationPlanfortheComprehensiveReformPilotinPudongNewArea(2023–2027),10andtheSeveralMeasurestoSupportHigh-qualityDevelopmentofInnovativeMedicine(2024)(DraftforConsultation).11However,therealbenefitsforbusinesseshingeonhowthesepolicieswillbeputintopractice.Thisnecessitates

5OpinionsonFurtherOptimisingtheForeignInvestmentEnvironmentandStrengtheningtheAttractionofForeignInvestment,StateCouncil,13thAugust2023,viewed23rdApril2024,<

/zhengce/content/202308/

content_6898048.htm

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6ActionPlantoPromoteHigh-levelOpening-upandAttractForeignInvestment,StateCouncil,19thMarch2024,viewed23rdApril2024,<

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zhengce/content/202403/content_6940154.htm

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7EuropeanBusinessinChinaBusinessConfidenceSurvey2024,EuropeanUnionChamberofCommerceinChina,10thMay2024,viewed10thMay2024,<

/en/publications-business-confidence-

survey

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8TheNationalHealthcareSecurityWorkConferencewasheldinBeijing,NationalHealthcareSecurityAdministration,9thJanuary2024,viewed23rdApril2024,<

/art/2024/1/9/art_14_11932.html

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9ReviewandProspectsofChina’sMedicalDeviceMarketin2023,BostonConsultingGroup,6thMarch2024,viewed23rdApril2024,<

https://mp.weixin.

/s/PJxOJYKDdWJdtuExPSsKWg

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10TheGeneralOfficesoftheCPCCentralCommitteeandtheStateCouncilIssuedtheImplementationPlanfortheComprehensiveReformPilotinPudongNewArea(2023–2027),Xinhua,22ndJanuary2024,viewed23rdApril2024,<

/zhengce/202401/content_6927503.htm

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11AnnouncementonRequestingPublicOpinionsontheConsultationDraftoftheSeveralMeasurestoSupportHigh-qualityDevelopmentofInnovativeMedicine

(2024)(DraftforConsultation)IssuedbyBeijingMedicalInsuranceBureauandNineOtherDepartments,BeijingMunicipalMedicalInsuranceBureau,7thApril2024,viewed23rdApril2024,<

/hudong/gfxwjzj/

zjxx/202404/t20240407_3610906.html

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ongoingmonitoring.

ThelegislativeprocessforChina’sMedicalDeviceAdministrationLawisprogressingswiftly,anditishopedthatthefinalversionwillhelptooptimiseregulationofthemedicaldeviceindustry.ThelawwasprioritisedinthelegislativeplansoftheNationalPeople’sCongressStandingCommitteeandtheStateAdministrationforMarketRegulation.12&13

KeyRecommendations

1.HarmoniseNamingRequirementsfor

MedicalDevices

Concern

Discrepanciesbetweenregistration-approvednamesandthosespecifiedinmarketaccessrequirementsbynationalandprovincialhealthcaresecurityadminstrationscannegativelyimpactbothmarketaccessandinsurancereimbursement.

Assessment

TherearesometimesdiscrepanciesbetweenproductnamesonNMPA-approvedregistrationcertificatesandthoseintheHealthcareServicePricingCatalogue.Accurateandconsistentnamingofmedicaldevicesiscrucialformedicalinsurancebillingandreimbursement,necessitatingalignmentwitheachprovince’sHealthcareServicePricingCatalogue.Thepresentsystemposesnumerouschallengesforpost-marketaccess,largelyduetovaryingregulationsandadministrativeapproachesbothamongdifferentauthoritiesandacrossdifferentgeographies.Thiscausesdifficultiesforhospitalswhenchargingfeesandapplyingformedicalinsurancereimbursement,astheymustmatchthemedicalservicetheyprovidewiththeitemslistedinthecatalogue.Thisincludesmatchingthenamesofin-vitrodiagnostic(IVD)reagentsandmedicalconsumableswiththeircorrespondingnamesasincludedinthecatalogue,includingthoseofchargeable

12LegislativePlanoftheStandingCommitteeofthe14thNationalPeople’sCongress,Xinhua,7thSeptember2023,viewed23rdApril2024,<

http://www.

/politics/2023-09/07/c_1129851114.htm

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13TheStateAdministrationforMarketRegulationLaysOutKeyLegislativeTasksfor2024,StateAdministrationforMarketRegulation,9thApril2024,viewed23rdApril2024,<

/xw/zj/art/2024/

art_3d1f417b56774f8da59f0afdda4939bc.html

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SectionThree:Goods

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Europeanchamber中国欧盟商会

consumables,14whichisnotalwayspossible.

Misalignmentsbetweentheregisterednamesofconsumables,IVDreagentsandmedicalserviceitemscanalsoleadtopenaltiesduringmedicalinsuranceinspectionsandaudits.Suchdiscrepanciescanimplyadifferencebetweentheservicesprovidedandthosebilledfor,potentiallyimpactingmedicalinsurancereimbursement.Thiscanmakemedicalprofessionalshesitanttoprescribecertainmedicalservicesduetofearofpotentialreprisals.

Thereisalsoasubstantialvariationinpricingpolicyamongprovincesandcities,leadingtoadisjointedmedicalinsurancecatalogueforconsumables.Thereisneitherastandardisedpricingsystemnorstandardisednamingsystemforsimilarproducts.Thislackofuniformityimpliesthatidenticalproductscanbereferredtobydifferentnamesindifferentregions,complicatingthehospitaltenderingprocessfurther.Thisfragmentationconstitutesamarketaccessbarrierformedicaldevicecompanies,witheachprovincehavingitsownaccessrequirements.Thismayposesignificantchallengestopaymentprocessesandassociatedprocedures.

Inaddition,whenassigningmedicalinsurancecodestoconsumablesandIVDreagents,confusionoftenarisesduetoimperfectalignmentbetweentheregisteredproductnameandthemedicalinsuranceclassification,whichraisesdoubtsoverwhichmedicalinsuranceclassificationshouldbeselected.ThisisbecausetheNationalMedicalProductsAdministration(NMPA)enforcesspecificnamingrequirementsformedicaldevicesandIVDreagents,strictlyadheringtoregulationsandguidingprinciplesduringproductregistration,renewalormodification,15whiletheNHSAisdevelopingnamingrulesforgenericitemsusedinrelationtomedicalinsurance.Despitebothsystemsconsideringsimilarfactors,theyarenotharmonised,withdifferencesingranularityandinteroperabilityrequirementssometimespreventingconsistency.

14RegulationsontheSupervisionandControloftheUseofMedicalSecurityFund(DecreeNo.735oftheStateCouncilofthePeople'sRepublicofChina,2021),StateCouncil,19thJanuary2021,viewed24thApril2024,<

/zhengce/content/2021-02/19/content_5587668.

htm?eqid=ee8973e500006d3d00000004646dd3f4

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15NamingRulesforGenericNamesofMedicalDevices(OrderNo.19oftheChinaFoodandDrugAdministration,2015),NationalMedicalProductsAdministration,21stDecember2015,viewed24thApril2024,<

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cn/gongbao/content/2016/content_5059099.htm

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Furthercomplicatingthisissue,theNationalHealthCommission(NHC)releasedtheNationalTechnicalSpecificationforMedicalServiceItems(2023Edition)(Specification)inSeptember2023,16mandatingthatdoctorsensureuniformityinthelistingofmedicalitemsandassociatedproductnamesintheirorders.TheSpecificationdelegatesresponsibilitytohospitalsandlocalhealthcommissionstoguaranteealignment.IftheNMPA,theNHSA,andtheNHCweretoeachmaintainadistinctsetofproductnamingregulationsthatlackfullcompatibilitywithoneanother,itwouldfurtherexacerbatetheissuespreviouslyoutlined.

Thedisconnectbetweenpre-marketapprovalandsubsequentproductclassificationformarketaccesscanalsooccasionallyresultinproductswithsimilarcharacteristicsandclinicalvaluesbeingallocateddifferentregisterednames.ThispresentsasignificantissueduringVBP,asproductgroupingcanattimeshingeontheregisterednames.Consequently,productswithidenticalcharacteristicsandclinicalvaluemayendupindifferentgroupsduetoanamingerror,whichistothedisadvantageofthoseproductsthathavebeenmisclassified.

Recommendations

•EstablishamechanismbetweentheNMPA,theNHSAandtheNHCtoensureunifiednamingrequirementsformedicaldeviceproducts.

•Grantmanufacturerstheautonomytonametheirregisteredproducts,providedtheymeettherequirementsofboththemedicalproductsadministrationauthorityandthemarketaccess

process.

•ConsidertheNMPA’sclassificationandnamingguidelinesformedicaldeviceswhenformulatingmarketaccess-relatedregulations,includingmedicalservicepricecatalogues,medicalserviceitemsandmedicalinsurancerulesfornaminggenericitems.

•Establishalinkbetweenthenamesofapprovedmedicalproductsandtheircorrespondingdesignationsinmedicalserviceitemstostreamlinetheproduct’smarketaccessprocess.

•Standardisehospitalserviceitemsandmedicalservicepricecataloguesnationwide.

16NationalTechnicalSpecificationforMedicalServiceItems(2023Edition),NationalHealthCommission,NationalAdministrationofTraditionalChineseMedicineandtheNationalAdministrationofDiseaseControlandPrevention,28thSeptember2023,viewed24thApril2024,<

/caiwusi/

s7785t/202309/914aec9618944ee2b36621d33517e576.shtml?R0NMKk6uoz

OC=1697880837734

>

2.EliminateUnfairCompetition,Specifically

theTendencyofPublicHospitalstoFavourDomesticProductsinProcurementProceduresandtheChallengetoIPR

Concern

Foreignmedicalequipmentmanufacturersencounterunfairtreatmentduringtheprocurementprocessesofpublichospitals,whilealsofacingchallengestotheirintellectualpropertyrights(IPR),whichnegativelyimpactstheiroperationsandpotentiallydeterslong-terminvestmentinChina.

Assessment

ItwasreportedthatChina’sMinistryofFinanceandMinistryofIndustryandInformationTechnologyreleasedguidelinesin2021limitingtheprocurementof137categoriesofmedicalproductstodomesticsources.17&18Theguidelineshaveimpactedtheutilisationofleadingimportedmedicaldevicesindomesticmedicalinstitutions,despitethegovernment’semphasisonenhancingmedicaltechnology.

TheChineseGovernmenthasalsorepeatedlystressedtheneedtocreateastable,fair,transparent,andpredictablebusinessenvironmentandpromotehigh-levelopeningingovernmentprocurement.However,duringtheformulationandimplementationofthe

AuditingGuidelinesforGovernmentProcurementofImportedProducts(2021Edition),noopinionsfromanyoftheaffectedindustriesweresought,resultinginmanyunreasonableequipmentparametersandprocurementratios.19

Althoughmanymedicalinstitutionsstillhaveanessentialneedforimportedproducts,asofthreeyearsago,importedproductshaveoftenbeenexcludedduringtheprocurementdocumentpreparationstage,orhavebeenunabletoentertheimportcertificationprocess.Inmanycases,thishasresultedinmedicalinstitutionshavingtoabandontheprocurementof

17Shalal,A,Chinaquietlysetsnew'buyChinese'targetsforstatecompanies-U.S.sources,Reuters,3rdAugust2021,viewed26thApril2024,<

https://www.

/gongbao/content/2016/content_5059099.htm

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18ReportonG20TradeMeasuresMid-Maytomid-October2021,WorldTradeOrganization,28thOctober2021,viewed30thMay2024,<

https://www.wto-

/content/books/9789287054203/read

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19Thedocumentstipulatesthatspecificspecialisedequipmentbeprocuredlocally

100percentofthetime.However,atthattime,thesemarketsweresaturatedwithimportedproducts.Thisrequirementeffectivelyexcludesallmajorproductsinthesemarkets.Furthermore,theproductspecificationsandcriteriaappeartodisproportionatelyfavourcertaincompanies,givingthemanundueadvantageinlocaltenders.

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importedproductsthatbettermeettheiractualneeds.ThishasputforeignsuppliersattemptingtoaccessChina’sgovernmentprocurementmarketatasignificantdisadvantagetolocalmanufacturers.Ifthissituationcontinuesitwilllikelyleadtoamonopolymarket,hinderinginnovationinthelocalmedicaldeviceindustryanddeprivingpatientsinChinaofthemostadvancedtreatment.

Thishasaknock-onimpactontheconsumablesthatareutilisedalongsidemedicalequipmentincertainVBPprojects.Thisisbecause,ifgovernmentprocurementdoesnotpermitthepurchaseofimportedmedicalmainframeequipment,itisnotpossibletoutilisethecorrespondingconsumables,whichwillpotentiallypreventthefulfilmentofVBPcontracts.20

TheChineseauthoritieshavepledgedtoclearlydefine‘domesticallyproducedproducts’and‘domesticproducts’.21Overall,thisapproachofclarifyingrulestoensurethatdomesticallyproducedproductsofforeign-fundedenterprisesarenotdiscriminatedagainstingovernmentprocurementiscommendable.However,consideringthesignificantdifferencesinthelevelsoflocalisationamongforeignindustryplayers,aswellasthecomplexityofinternationalsupplychains,ifthesedefinitionsdonotreflectthecurrentrealityorareoverlystringent,itwillresultinunfaircompetitioningovernmentprocurementbetweenproductsthatareproduceddomesticallybyforeign-fundedenterprisesandthoseproducedbydomesticmanufacturers.Thiswouldfurtherreducetheappetiteamongforeignmedicaldevicecompaniestomakelong-terminvestmentsinChina.

Additionally,governmentprocurementprocessesinChinacanputcompanies’IPRatrisk.InsomeVBPsofmedicalconsumablesorganisedbylocalhealthsecuritybureaus,medicalmanufacturersaresimplyrequiredtosubmitanIPRself-declaration.Thismakesitverychallengingforlocalgovernmentstorevieweverymanufacturer’slegalityandqualification,asitreliesonmanufacturersprovidinghonest,completeandfactually

20Alackofcoordinationbetweentwopoliciescancausedifficultiesforhospitals.Ifcertainmedicaldevicesandtheirrespectiveconsumablesareusedtogether,notbeingabletopurchasethedevicecanhindertheacquisitionofenoughconsumablestomeetthecontractvolumeoutlinedinthepurchasingagreement.

21OptimisetheCriteriaandAuditProceduresforDeterminingDomesticGoods,andCoordinateDomesticGoodsStandardswithGPAContent,ChinaGovernmentProcurement,28thNovember2023,viewed27thApril2024,<

/llsw/202311/t20231128_21158658.htm

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correctinformationthatcannotbeindependentlyverified.Inanattempttocounterthis,theNHSAandtheChinaNationalIntellectualPropertyAdministrationjointlyissuedtheOpinionsonStrengtheningIntellectualPropertyProtectionintheFieldofCentralisedMedicalProcurementin2022,22whichstatethatitisnecessarytoestablishacoordinatingmechanismbetweenChina’sintellectualpropertyregimeandthegovernmentprocurementsystemformedicaldevices.However,thishasnotyettakenplace.TheIPRofmedicalconsumablesarefarmorecomplexduetothediversityofcategoriesinvolved(whichincludescomponentparameters,design,packagingandfunction,amongothers).Becauseoppositionandwaitingperiodsinlawsuitsareverylong,inpractice,aVBPcontractmaybeimplementedforoneortwoyearsbeforeacourtmakesadetermination.Thismeansthatduringthatperiod,publichospitalsmaybepurchasingandutilisingpotentiallyillegalproducts.Itisriskytoensurethesustainabilityofsupplyingproduct