CHAMBERSGLOBALPRACTICEGUIDES

Healthcare:

MedicalDevices2025

Definitivegloballawguidesoffering

comparativeanalysisfromtop-rankedlawyers

China:Law&Practice

AlanZhou,CocoFanandKellyCaoGlobalLawOffice

CHINA

LawandPractice

Contributedby:

AlanZhou,CocoFanandKellyCaoGlobalLawOffice

Contents

1.ApplicableProductSafetyRegulatoryRegimesp.4

1.1MedicalDevicesp.4

1.2HealthcareProductsp.5

1.3Medicinesp.5

1.4TechnologiesandDigitalHealthp.6

1.5BorderlineProductsp.7

2.CommercialisationandProductLifeCyclep.8

2.1DesignandManufacturep.8

2.2CorporateSocialResponsibility,theEnvironmentandSustainabilityp.10

2.3AdvertisingandProductClaimsp.10

2.4MarketingandSalesp.12

2.5Internationalisationp.15

2.6Post-MarketingObligations,IncludingCorrectiveActionsandRecallsp.16

3.RegulatorEngagementandEnforcementp.17

3.1RegulatoryAuthoritiesp.17

3.2RegulatoryEnforcementMechanismsp.19

4.Liabilityp.19

4.1ProductSafetyOffencesp.19

4.2ProductLiabilityp.19

4.3JudicialRequirementsp.20

4.4Costsp.20

4.5Product-RelatedContentiousMattersp.20

4.6ClassActions,RepresentativeActionsorCo-OrdinatedProceedingsp.21

4.7ADRMechanismsp.21

4.8InterrelationBetweenLiabilityMechanismsp.21

5.ApplicableProductSafetyRegulatoryRegimesp.22

5.1PolicyDevelopmentp.22

5.2LegislativeReformp.23

5.3ImpactofArtificialIntelligencep.23

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CHINALawandPractice

Contributedby:AlanZhou,CocoFanandKellyCao,GlobalLawOffice

GlobalLawOfficedatesbacktotheestablishmentofChina’sLegalConsultantOfficeoftheCouncilforthePromotionofInternationalTradein1979.GLOhasbecomeoneofthelargestandleadingChineselawfirms,withmorethan500lawyerspractisinginitsBeijing,Shanghai,ShenzhenandChengduoffices.Itslifesciencesandhealthcare(L&H)practicegroupwasoneofthefirstinChinaandprovides“one-stop”legalservicesforeveryareaoftheindustry,includingM&A,investmentandfunding,licenceinandout,dai-

lyoperation,IPprotectionandadviceoncompliance,includinginternalandgovernmentinvestigations,anti-briberymattersanddisputesettlement.Underachangingregulatoryenvironment,GLO’sL&Hteamhastheperfectcombinationofinternationalexperi-enceandlocalknow-howtosupportvariousinno-vationandpilotprojects,includingdigitalhealthcareandMAH/CMAHtrialcases.Theteamparticipatesextensivelyintheformulationoflocalcodesofcon-ductandbenchmarkpolicies/rules.

Authors

AlanZhouistheleadingpartnerof

theL&HpracticegroupatGlobalLawOffice,androutinelyrepresents

multinationalcorporations,well-

knownChinesestate-ownedand

privateenterprises,andprivate

equity/venturecapitalfundsintheL&Harea.Hehasbeenengagedbylocalauthoritiesandindustrial

associationstoadviseonlegislationandindustry

standardsintheL&Hindustry,includingthe

formulationofthecomplianceguidelinesforthe

healthcareindustry,thetextbookforCorporate

ComplianceOfficerProfessionalSkillStandards,

e-healthcare,medicalinsurancereformandmedicalrepresentativeadministration.MrZhouis

consistentlyrankedbyChambersandPartners,andisapublishedauthor.

CocoFanisapartnerintheL&H

practicegroupatGlobalLawOffice,specialisingincorporate,compliance,privateequityandventurecapital,

andM&A.HerrichexperienceintheL&Hpracticeincludesprescription

medicine,over-the-countermedicine,contract

researchorganisations,medicaldevices,

biopharmaceuticals,healthfoods,clinicalsupply,

vaccines,animalhealthandhospitals.MsFanhas

advisedmanymultinationalcompanies,private

companiesandinvestorsonriskassessmentand

healthchecks,andhastailoredtrainingregarding

anti-corruption,antitrust,promotionandother

regulatorycompliance.Shealsoadvisesonthe

establishmentofpharmaceuticalandmedicaldeviceindustrycompliancemanagementstandards.

KellyCaoisapartnerintheL&H

practicegroupatGlobalLawOffice.Hermainpracticeareasencompassdisputeresolution,complianceandriskcontrol,aswellaslabourand

employment.MsCaohasadvised

majorlifesciencescompaniesongeneral

complianceanddisputeresolution,andassists

multinationalenterprisesandwell-knowndomesticenterpriseswiththeirdisputesinlitigationand

arbitration.Shealsoprovideslegalservicesto

multinationalpharmaceuticalcorporations,assistingwiththeircompliancesystemestablishmentand

internalcomplianceinvestigations.

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CHINALawandPractice

Contributedby:AlanZhou,CocoFanandKellyCao,GlobalLawOffice

GlobalLawOffice

36thFloor

ShanghaiOneICC

No999MiddleHuaiHaiRoadXuhuiDistrict

Shanghai200031China

Tel:+862123108200

Fax:+862123108299

Email:alanzhou@

Web:

1.ApplicableProductSafetyRegulatoryRegimes

1.1MedicalDevices

ProductSafetyRegulatoryRegimeforMedicalDevices

Classificationofmedicaldevices

UnderthePRC’slegalregime,“medicaldevices”referstoinstruments,equipment,appliances,invitrodiagnosticreagentsandcalibrators,materialsandothersimilarorrelevantarticles,includingnecessarycomputersoftwarethataredirectlyorindirectlyusedforthediagnosis,prevention,monitoring,treatmentorreliefofdiseasesorinjury,thefunctionalcompensationofinjuries,theinspection,substitution,adjustmentorsupportofphysiologicalstructuresorphysiologicalprocesses,thecontrolofpregnancy,orthesupportormaintenanceoflife.Unlikeapharmaceuticalproduct,theutilityofmedicaldevicesismainlyachievedbyphysicalorothermeansratherthanpharmacologi-cal,immunologicalormetabolicmeans,orwherethelattermeansonlyactasauxiliaryfunctions.“Medicalinstrument”isnotalegallydefinedtermunderthePRC’slaws;undertheprevailinglegaldefinition,medi-caldevicesencompassmedicalinstruments.

Activitiesrelatingtomedicaldeviceshavebeenstrict-lyregulatedinthePRC,withtheregulationsthatapplytoamedicaldeviceinthePRCdependingonhowthatmedicaldeviceisclassified.Medicaldevicesarecategorisedintothreeclassesaccordingtotheirrisklevels.TheNationalMedicalProductsAdministra-

tion(NMPA)determinesamedicaldevice’srisklevelaccordingtoitsintendedpurposes,itsstructuralfea-tures,theformofuse,whetheritisincontactwithorhasaccesstothehumanbody,andotherfactors.Ingeneral:

?ClassImedicaldevicesrefertothosethathavealowdegreeofrisk;

?ClassIImedicaldevicesrefertothosewithamediumdegreeofrisk;and

?ClassIIImedicaldevicesrefertothosewiththehighestrisklevel.

ClassImedicaldevicesaresubjecttorecord-filingadministration,andClassIIandClassIIImedicaldevicesaresubjecttoregistrationadministration.

Regulationofmedicaldevices

TheRegulationsfortheSupervisionandAdministra-tionofMedicalDevices(RSAMD)setuptheregulatoryframeworkfortheadministrationofmedicaldevices.Thedevelopment,registration,manufacturinganddistributionofmedicaldevicesareregulatedbymoredetailedgoodpracticerulesandadministrativemeas-ures,suchasGoodManufacturingPractice(GMP),GoodClinicalPractice(GCP)andGoodSupplyPrac-tice(GSP)forMedicalDevices.

Subjecttotheclassificationofthemedicaldevices,theregistrantsortherecord-filingholdersofthemedi-caldevices–analogoustothemarketingauthorisationholders(MAHs)ofthemedicaldevices–areresponsi-

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bleforthequalitymanagementofthewholelifecycleofmedicaldevices,andforthesafetyandeffective-nessofmedicaldevicesinthewholeprocessofthedevelopment,manufacturing,distributionanduseofsuchmedicaldevices,accordingtoapplicablelawsandregulations.Thosewhowishtoengageinclinicaltrials,orthemanufacturingordistributionofmedicaldevices,mustalsoobtainapermitorapproval,whichisdiscussedin2.CommercialisationandProductLifeCycle.

Software-BasedMedicalDevices

See1.4TechnologiesandDigitalHealth.

ProductSafetyRegulatoryRegimeforPersonalProtectiveEquipment(PPE)

“PPE”isnotadefinedlegaltermunderPRClaws.

Iftheprotectivearticlesusedbymedicalstafffallwithinthescopeofmedicaldevices,suchasmedicalprotectiverespiratorsandmedicalprotectiveclothing,theyareregulatedasmedicaldevices.

Therearespecificrequirementsfor“speciallabourprotectionarticles”,suchassafetyhelmets.Thecur-rentregulationsonspeciallabourprotectionarticlesarelessstringentthantheregulationsformedicaldevices,whilegenerallabourprotectionarticlesandotherPPEaredeemedtobeordinaryproductswithnospecialregulatoryrequirementsfortheirmarketing,manufacturinganddistribution.

1.2HealthcareProducts

ProductSafetyRegulatoryRegimeforHealthcare

Products

Cosmeticsaregovernedbyadministrativeregula-tions,rangingfrommanufacturingtomarketing,businessoperationandpost-marketmonitoring.TheRegulationsontheSupervisionandAdministrationofCosmetics(RSAC)areamongthemostsignificantregulationsinthehierarchy,whichapplyaClassifica-tionSupervisionSystemtocosmetics,asfollows:

?specialcosmetics(ie,thoseusedforhaircolour-

ing,hairperming,freckleremovalandwhitening,

sunprotectionandhairlossprevention)andthosethatclaimnewefficacymustberegisteredwiththe

competentauthoritiesbeforemanufacturingandimport;and

?ordinarycosmetics(ie,cosmeticsotherthanspe-cialcosmetics)onlyneedtoberecord-filedpriortobeingmarketedorimported.

Biocidesfallunderthelegislativeregimeofpesticidesandthusmustcomplywiththestrictlyregulatedsys-temforpesticides.AccordingtotheRegulationsonPesticideAdministration(RPA),correspondinglicenc-esmustbeobtainedfromthecompetentauthoritiesforthemanufacturing,marketingandbusinessopera-tionofpesticides.Post-marketmonitoringofpesti-cidesisalsoahighlyregulatedarea.

Food–includingGeneticallyModifiedOrganisms(GMOs)–isclassifiedaseitherconventionalfoodorspecialfood,withthelattercoveringhealthfood,whichreferstofoodwithspecifichealthcarefunctions–ie,issuitableforspecificgroupsofpersonsduetoitsfunctionsforbodyregulation,butnotforthepurposeofdiseasetreatment,andincludesnutritionsupplements.TheFoodSafetyLaw(FSL)regulatestheproduction,distribution,safety,labels,inspection,andimportandexportoffoodproducts,andtherearemanyspecificregulationsregulatingdifferentkindsoffood,suchastheAdministrativeMeasuresforReg-istrationandRecord-FilingofHealthFood,andtheRegulationsonAdministrationofAgriculturalGeneti-callyModifiedOrganismsSafety.Therefore,nutritionsupplementsmustfollowtheFSLandaresubjecttospecialregulationsforhealthfood:theCatalogueManagementSystemunderAdministrativeMeasuresfortheCatalogueofIngredientsandtheCatalogueofHealthcareFunctionsofHealthFood.

Biocidesfallunderthelegislativeregimeofpesticidesandthusmustcomplywiththestrictlyregulatedsys-temforpesticides.AccordingtotheRPA,correspond-inglicencesmustbeobtainedfromthecompetentauthoritiesforthemanufacturing,marketingandbusi-nessoperationofpesticides.Post-marketmonitoringofpesticidesisalsoahighlyregulatedarea.

1.3Medicines

“Pharmaceuticals”,“medicines”and“drugs”refertosubstancesthatareusedtoprevent,treatordiagnosehumandiseases,andareintendedtoregulatehuman

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physiologicalfunctions,forwhichtheusageanddos-agearespecifiedforindicationorprimarytreatment.ThefundamentallawregulatingpharmaceuticalsinChinaistheDrugAdministrationLaw(DAL),whichgovernsvariousdrug-relatedactivities,includingtheirdevelopment,registration,manufacturinganddistri-bution.

Clinicaltrialsofpharmaceuticalsareregulatedbylawsandanarrayofguidanceandtechnicalreviewstandards.Specifically,theDAL,theAdministrativeMeasuresforDrugRegistrationandtheGCPoutlinetheframeworkforadministrationonclinicaltrialsofpharmaceuticals,andspecifythedetailedobligationsofthepartiesinvolved,operationalproceduresandtechnicalrequirements.

Detailsontheregulationofpharmaceuticalsandrel-evantclinicaltrialscanbeviewedinthe

ChinaLaw

andPractice

chapterinthe2025ChambersLifeSci-encesGlobalPracticeGuide.

BloodProducts

UnderthePRC’slegalregime,bloodproductsreferto,inparticular,varioushumanplasmaproteinprod-ucts,whicharegovernedaspharmaceuticals,andasbiologicalmedicinalproducts.Asaspecialcategoryofmedicinalproducts,inadditiontotheregulationsgenerallyapplicabletodrugs,bloodproductsarealsosubjecttotheRegulationsontheAdministrationofBloodProductsandotherspecialregulatoryrequire-ments.Forinstance:

?thesourceplasmafortheproductionofbloodproductsshallonlybeobtainedfromaqualifiedsupplier;

?bloodproductsaregenerallysubjecttobatchreleaseadministrationpriortomarketing;and

?bloodproductsshallnotbecontractedformanu-facturenorsoldonline.

Chinaisacceleratingtheinformatisationconstructionofthebloodproductproductionandinspectionpro-cesses.TheNMPAhasissuedtheSmartSupervisionThree-YearActionPlanforBloodProductProduction(2024–2026),aimingtoessentiallyachieveinforma-tisedmanagementinbloodproductproductionenter-prisesbytheendof2026.

Psychedelics

“Psychedelics”isnotadefinedlegaltermunderPRClaw.Certainpsychedelics,ifusedproperly,mayfunc-tionasapsychotropicsubstance.Ifsuchpsyche-delicsfurtherfallwithintheCatalogueofPsychotropicSubstances,theyareeligibletobeappliedundertheadministrationoftheNMPAandregisteredasadrugsubjecttoregulation.TheCatalogueofPsychotropicSubstancesisestablished,updatedandpublishedbytheNMPAinconjunctionwiththeMinistryofPublicSecurityandtheNationalHealthCommission(NHC).UnderPRClaw,psychotropicsubstancesarecatego-risedandregulatedbasedontheirrisklevel,fromhightolow,intoClassIandClassII.ClassIpsychotropicsubstancesareclassifiedashavingthehighestrisklevel,andmustbemanufacturedandsoldunderstrictcontrol.

Inadditiontotheregulationsgenerallyapplicabletodrugs,psychotropicsubstancesarealsosubjecttotheRegulationsontheAdministrationofNarcoticDrugsandPsychotropicSubstancesandotherspe-cialregulatoryrequirements.Forinstance,theR&Dandmanufacturingofpsychotropicsubstancesaresubjecttospecialapproval,andpsychotropicsub-stancesshallneitherbecontractedformanufacturenorsoldonline.

Cannabidiol(CBD)

CBDisanactiveingredientofcannabisthatcannotbeusedasarawmaterialforcosmeticsinaccordancewiththeListofProhibitedRawMaterialsforCosmet-icsissuedbytheNMPA.Furthermore,cannabidiolislistedintheCatalogueofClassIIPrecursorChemicalsandissubjecttotheRegulationsontheAdministra-tionofPrecursorChemicals.Inaddition,preclinicalresearchonCBDformedicalpurposesshallsatisfythespecificconditionsprescribedbyregulationsandobtainapprovalfromtheNMPA.

1.4TechnologiesandDigitalHealth

Certainmedicalapps,tele-medicineinformationsys-temsandwearablesmaybeclassifiedasmedicaldevicesiftheymeetthedefinitionofamedicaldevice,asdiscussedin1.1MedicalDevices.

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MedicalApps

Medicaldevicesoftwarecanbedividedintotwomaincategories:SoftwareasaMedicalDevice(SaMD)andSoftwareinaMedicalDevice(SiMD).

SaMD

SaMDreferstosoftwareintendedtobeusedforoneormoremedicalpurposesthatperformsthesepurposeswithoutbeingpartofahardwaremedicaldevice.TherearetwotypesofSaMD:genericSaMDanddedicatedSaMD.

GenericSaMDisusuallyusedinconjunctionwithmul-tiplemedicaldevicesbasedonagenericdatainter-face,suchasmedicalimageprocessingsoftwareandpatientmonitoringsoftware.GenericSaMDisgener-allyregisteredasamedicaldeviceseparately.

DedicatedSaMDislinkedtoaspecificmedicaldevicebasedonagenericordedicateddatainterface,whichcouldberegisteredeitherasanindependentmedi-caldeviceoraspartofahardwaremedicaldevice.Ifregisteredaspartofahardwaremedicaldevice,itwillberegardedandregulatedasasoftwarecomponent,ratherthanasamedicaldevice.

SiMD

SiMDreferstosoftwarethatisintendedtobeusedforoneormoremedicalpurposesandthatcontrolsordrivesahardwaremedicaldeviceorrunsonadedi-cated/medicalcomputingplatform.ASiMDisacom-ponentofamedicaldevicethatshallnotberegisteredasamedicaldeviceindependentlybutshouldbereg-isteredalongwiththemedicaldeviceitworkswith.

Wearables

Wearablesthatmeetthedefinitionofmedicaldevicesasdiscussedin1.1MedicalDevicesareclassifiedandregulatedasmedicaldevices.Otherwise,theyareregulatedaselectricalorelectronicproducts,suchasmassagers,exercisemachinesorheart-ratemonitorsforexercise.

Telemedicine

Atelemedicineinformationsystemisusedfortel-emedicineservices.Equipmentinthetelemedicineinformationsystemthatmeetsthedefinitionofamedi-caldeviceisregulatedasamedicaldevice.According

toGoodPracticesforTelemedicineServices(forTrialImplementation),thetelemedicineinformationsys-temshallensurethatimages,sounds,textsandothermedicalinformationrequiredinthetelemedicineser-vicecanbetransmittedsafelyandintime,andensurethattheimagesareclearandthatthedataisaccurate.Thetelemedicineinformationsystemmustalsocon-formtotheTechnicalGuidelinesforConstructionoftheTelemedicineInformationSystemandmeettherequirementsofclinicaldiagnosis.

StemCells

Stemcellsareself-renewing,highlyproliferativecellsthatcanfurtherdifferentiateintovarioustissuecells.Chineseregulationofstemcellproductshasgonethroughatransition,fromtreatingthemasdrugsatthebeginningtotreatingthemasathirdtypeofmedicaltechnology,andcurrentlytotreatingthemasdrugsagain.

1.5BorderlineProducts

MedicinesandMedicalDevices

Generally,medicinesandmedicaldevicesaretwotypesofproductswithsimilarstringentregulationmethods.TheMAHofmedicinesorthemedicaldeviceregistrants/record-filingholdersareresponsi-bleforthewholelifecycleoftheproducts.

Inpractice,certaintypesofproductsmayhavefea-turesofbothmedicinesandmedicaldevices,andwillbecategorisedaseithermedicinesormedicaldevicesdependingonthecharacteristicsofsuchproducts.

?Acombinationproduct–asamedicalproduct

containingbothadrugandadevice,applicantsshouldapplyforitsregistrationasadrugifit

mainlyactsasadrug,andasamedicaldevice

ifitmainlyactsasamedicaldevice.According

totheRulesforMedicalDeviceClassification,ifacombinationproductmainlyactsasamedicaldevice,itshallbemanagedasaClassIIImedicaldevice.Ifitsmajorutilitycannotbeeasilyidenti-fied,theapplicantshouldapplytotheCentreforMedicalDeviceStandardisationAdministrationoftheNMPAinordertodefinethecharacteristicsofsuchcombinationproductbeforeapplyingforitsregistration.

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?Invitrodiagnosis(IVD)reagents–underthePRC

legalregime,mostIVDreagents(includingrea-

gents,kits,calibratorsandqualitycontrolproductsusedforinvitrotestingofhumansamplesinthe

processofdiseaseprediction,prevention,diag-

nosis,treatmentmonitoring,prognosisobserva-

tionandhealthstatusevaluation)aredefinedas

medicaldevices,exceptforIVDreagentsforbloodsourcescreeningandIVDreagentslabelledwith

radionuclides,whicharecharacterisedasdrugs.

IVDreagentsarecategorisedbyrisklevelfromlowtohighintoClassI,ClassIIandClassIII.IVDrea-gentsinClassIaresubjecttorecord-filingadmin-istration,whileIVDreagentsinClassIIandClassIIIaresubjecttoregistrationadministration.

PPEandMedicines

PPEandmedicinesaredifferentcategoriesofprod-uctsunderdifferenttypesofregulations.Asmen-tionedin1.1MedicalDevices,theprotectivearticlesusedbymedicalstaffthatfallwithinthescopeofmedicaldevicesareregulatedaccordingtotherulesformedicaldevices.

MedicinesandFood

Consumersmayconfusehealthfoodswithmedicinesbecausehealthfoodmayclaimcertainfunctionsofhealthprotection.However,theFSLstipulatesthatfood,includinghealthfood,excludessubstancesthatareusedforthepurposeoftreatment,andfurtherstressesthatlabelsanddescriptionsofhealthfoodshallnotrefertoanypreventativeortherapeuticfunc-tionbutshallinsteadstatethattheycannotreplacemedicine.

2.CommercialisationandProductLifeCycle

2.1DesignandManufacture

RequirementsforManufacturingMedicalDevices

Themanufactureofmedicaldeviceseitherforclini-caluseorforcommercialisationmustcomplywiththerequirementsoftheRSAMD,theMeasuresfortheSupervisionandAdministrationofMedicalDeviceManufacture,andGMPforMedicalDevicesinthePRC.GMPforMedicalDevicescontainsgeneralrequirementsregardingorganisationandpersonnel,

premisesandfacilities,equipment,documentman-agement,designanddevelopment,purchasing,man-ufacturingmanagement,qualitycontrol,distributionandafter-salesservices,controlofnon-conformingproducts,monitoring,analysisandremediationofadverseevents,andotherspecificrequirementsforcertainproducts.

?Formanufacturingsites,thepremisesmustmeet

themanufacturingrequirements–eg,theproduc-tionareamustbeofsufficientcapacitytosuitthescaleofproductionandthevarietiesoftheprod-

ucts;theoveralllayoutoftheproduction,adminis-trativeandancillaryareasmustbereasonable;andsuchareasmustnotinterferewitheachother.

?Fordesignanddevelopmentplanning,amanu-

facturermustsetoutthedesignanddevelopmentstagesaswellasthereview,verification,validationanddesigntransferactivitiestobeperformedat

eachstage.Thedesignanddevelopmentinputs

mustincludethefunctional,performanceandsafe-tyrequirementsaccordingtotheintendedpurpose,regulatoryrequirements,andriskmanagement

andcontrolmeasures.Designanddevelopment

outputsmustmeettheinputrequirements,includ-ingtherelevantinformationneededforpurchase,manufactureandservices,andproducttechnicalrequirements.

?Themanufacturermustkeeplegibleandcompleterecordsthatensurethetraceabilityofactivities

suchasthemanufactureandqualitycontroloftheproducts.

?Unlessotherwisespecifiedbytheapplicablelawsorregulations,alltherecordsmustberetainedforaperiodequivalentatleasttothelifespanofthemedicaldeviceandfornotlessthantwoyears

fromthedateofreleaseoftheproduct.

Inadditiontotheabove-mentionedGMPrequire-ments,themanufacturerofmedicaldevicesmustobtainalicenceorrecord-filingbeforeitmanufacturesmedicaldevicesforcommercialisation.Therequi-sitepermitsformanufacturingmedicaldevicesvarybasedupontheclassificationofthemedicaldevicestobemanufactured.FormanufacturingClassImedi-caldevices,amanufacturingrecord-filingreceiptisrequired,whilealicencemustbeobtainedformanu-facturingClassIIand/orClassIIImedicaldevices.

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ContractManufacturingofMedicalDevices

ExceptforthemedicaldeviceslistedintheCatalogueofMedicalDevicesProhibitedfromEntrustedManu-facturing,theMAHofmedicaldevicescanentrustaqualifiedthird-partymanufacturertomanufacturethemedicaldevices.Insuchacase,thepartiesmustenterintoanagreementtoprescribetheresponsibili-tiesofeachparty,especiallytheresponsibilitiesandliabilitiesforproductqualityassurance.

HealthcareProducts

Unlessthelawandregulationprovideotherwise,alicenceformanufacturingisaprerequisitefortheproductionofcosmeticsandfood.Manufacturersofcosmeticsandfoodmustfollowtherespectivemanu-facturingrequirements.

GMPforCosmeticsisageneralguidelineforcosmet-icsmanufacturerstodevelopaninternalqualitycon-trolsystem,which,inturn,isthestandardforcompe-tentauthoritiestoinspectwhetherthemanufacturingqualifies.KeyaspectsofGMPforCosmeticsinclude:

?organisationandpersonnel;

?qualityassuranceandcontrol;

?managementoffactoryfacilitiesandequipment;

?managementofmaterialsandproducts;

?manufacturingprocessmanagement;

?managementofentrustedmanufacturing;and

?managementofproductsales.

FoodproductionmustconformtotherequirementsstipulatedbytheFSLandawholesetofnationalstandardsregardingfoodsafety.Keyrequirementsinclude:

?theestablishmentoftheinternalfoodsafetyman-agementsystem;

?theself-inspectionsystemforfoodsafetyandtheimplementationofcontrolsoverrawmaterials;

?self-controlconcerningtheproductionprocess;

?safetyofequipment,storageandpackaging;and

?inspectionandcontroloverfinishedproducts,transportationanddelivery.

RequirementsforManufacturingMedicines

Generally,themanufactureofmedicinesmustcom-plywiththeDAL,theMeasuresfortheSupervision

andAdministrationofDrugManufacture,andGMPforMedicines,amongotherregulationsandguidelinesinthePRC.Undersuchlegalframework,theprerequi-sitesformanufacturingmedicinesincludeobtainingdrugmanufacturinglicencesandhavingpharmaceuti-