医疗器械及消费者健康产品（2022版）

Definitivegloballawguidesofferingcomparativeanalysisfromtop-rankedlawyers MedicalDevices&ConsumerHealthProducts2022 China:Law&Practice AlanZhou,CocoFan,KellyCaoandSylviaDongGlobalLawOffice practiceguides.chambers.com LawandPractice Contributedby: AlanZhou,CocoFan,KellyCaoandSylviaDong GlobalLawOfficeseep.23 CONTENTS 1.ApplicableProductSafetyRegulatoryRegimesp.3 1.1MedicalDevicesp.3 1.2HealthcareProductsp.4 1.3NewProducts/TechnologiesandDigitalHealthp.5 1.4BorderlineProductsp.6 2.CommercialisationandProductLife Cyclep.7 2.1DesignandManufacturep.7 2.2CorporateSocialResponsibility,the EnvironmentandSustainabilityp.8 2.3AdvertisingandProductClaimsp.9 2.4MarketingandSalesp.11 2.5Internationalisationp.13 2.6Post-marketingObligations,Including CorrectiveActionsandRecallsp.15 3.RegulatorEngagementand Enforcementp.16 3.1RegulatoryAuthoritiesp.16 3.2RegulatoryEnforcementMechanismsp.17 CHINA 4.Liabilityp.17 4.1ProductSafetyOffencesp.17 4.2ProductLiabilityp.17 4.3JudicialRequirementsp.18 4.4Costsp.18 4.5Product-RelatedContentiousMattersp.19 4.6ClassActions,RepresentativeActionsor Co-ordinatedProceedingsp.19 4.7ADRMechanismsp.20 4.8InterrelationBetweenLiabilityMechanismsp.20 5.PolicyandLegislativeReformp.21 5.1PolicyDevelopmentp.21 5.2LegislativeReformp.21 5.3ImpactofCOVID-19p.22 1.APPLICABLEPRODUCTSAFETYREGULATORY REGIMES 1.1MedicalDevices ProductSafetyRegulatoryRegimeforMedicalDevices Classificationofmedicaldevices UnderthePRClegalregime,“medicaldevices”referstoinstruments,equipment,appliances,invitrodiagnosticreagentsandcalibrators,materi-alsandothersimilarorrelevantarticlesincludingnecessarycomputersoftwarethataredirectlyorindirectlyusedforthediagnosis,prevention,monitoring,treatmentorreliefofdiseasesorinjury,thefunctionalcompensationofinjuries,theinspection,substitution,adjustmentorsup-portofphysiologicalstructuresorphysiologicalprocesses,thecontrolofpregnancyorthesup-portormaintenanceoflife.Unlikeapharma-ceutical,theutilityofmedicaldevicesismainlyachievedbyphysicalorothermeansratherthanpharmacological,immunologicalormetabolicmeans,orwherethelattermeansonlyactasauxiliaryfunctions.“Medicalinstrument”isnotalegallydefinedtermunderthePRClaws.Gener-ally,medicalinstrumentswouldbeinterpretedasbeingthesameasmedicaldevices. ActivitiesrelatingtomedicaldeviceshavebeenstrictlyregulatedinthePRC,andtheregulationsthatapplytoamedicaldeviceinthePRCdependonhowthatmedicaldeviceisclassified.Medicaldevicesarecategorisedintothreeclassesaccordingtotheirrisklevels.TheNationalMedicalProductsAdministration(NMPA)determinesamedicaldevice’srisklevelaccordingtoitsintendedpurposes,structuralfeatures,theformofuse,whetheritisincon-tactwithorhasaccesstothehumanbody,andotherfactors.Ingeneral,ClassImedicaldevicesrefertothosethathavealowdegreeofriskandwhosesafetyandeffectivenesscanbeensuredthroughroutineadministration,andtherefore theyaremerelysubjecttoarecord-filingadmin-istrationunderthesupervisionoftheNMPAanditslocalcounterparts;ClassIImedicaldevicesrefertothosewithamediumdegreeofrisk;andClassIIImedicaldevicesrefertothosewiththehighestrisklevel,thesafetyandeffectivenessofwhichneedtobeensuredbystrictcontrolandregulation,andwhichthereforearesubjecttoregistrationadministrationunderthesupervisionoftheNMPA.TheNMPAhasissuedtheRulesforMedicalDeviceClassificationandtheCata-logueofMedicalDeviceClassificationtoguidethisclassificationofmedicaldevices. Regulationsofmedicaldevices TheRegulationsfortheSupervisionandAdmin-istrationofMedicalDevices(RSAMD)setuptheregulatoryframeworkfortheadministrationofmedicaldevices.Thedevelopment,registration,manufacturinganddistributionofmedicaldevic-esareregulatedbymoredetailedGxPrulesandadministrativemeasures,suchasGoodManu-facturingPractice,GoodClinicalPracticeandGoodSupplyPracticeforMedicalDevices. Subjecttotheclassificationofthemedicaldevic-es,theregistrantsortherecord-filingholdersofthemedicaldevices(ie,themarketingauthori-sationholders(MAHs)ofthemedicaldevices)areresponsibleforthequalitymanagementofthewholelifecycleofmedicaldevicesandareresponsibleforthesafetyandeffectivenessofmedicaldevicesinthewholeprocessofthedevelopment,manufacturing,distributionanduseofsuchmedicaldevicesaccordingtoappli-cablelawsandregulations.Thosewhowishtoengageinclinicaltrialsorthemanufacturingordistributionofmedicaldevicesmustalsoobtainapermitorapproval,whichisdiscussedin2.CommercialisationandProductLifeCycle. Software-BasedMedicalDevices Pleasesee1.3NewProducts/TechnologiesandDigitalHealth. ProductSafetyRegulatoryRegimeforPharmaceuticals(IncludingBloodProducts)“Pharmaceuticals”,“medicines”and“drugs”refertosubstancesthatareusedtoprevent,treatordiagnosehumandiseasesandareintendedtoregulatehumanphysiologicalfunctions,forwhichtheusageanddosagearespecifiedforindicationorprimarytreatment.Thefundamen-tallawregulatingpharmaceuticalsinChinaistheDrugAdministrationLaw,whichgovernsvariousdrug-relatedactivities,includingtheirdevelop-ment,registration,manufacturinganddistribu-tion.UnderthePRClegalregime,pharmaceuti-calsandmedicaldevi