环球律师事务所-医疗器械及消费者健康产品

Definitivegloballawguidesoffering

comparativeanalysisfromtop-rankedlawyers

MedicalDevices&

ConsumerHealth

Products2022

China:Law&Practice

AlanZhou,CocoFan,KellyCaoandSylviaDong

GlobalLawOffice

CHINA

2

LawandPractice

Contributedby:

AlanZhou,CocoFan,KellyCaoandSylviaDong

GlobalLawOffice

seep.23

CONTENTS

1.ApplicableProductSafetyRegulatory

Regimesp.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

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

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1.APPLICABLEPRODUCTSAFETYREGULATORYREGIMES

1.1MedicalDevices

ProductSafetyRegulatoryRegimefor

MedicalDevices

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/Technologies

andDigitalHealth.

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ProductSafetyRegulatoryRegimefor

Pharmaceuticals(IncludingBloodProducts)

“Pharmaceuticals”,“medicines”and“drugs”refertosubstancesthatareusedtoprevent,treatordiagnosehumandiseasesandareintendedtoregulatehumanphysiologicalfunctions,forwhichtheusageanddosagearespecifiedforindicationorprimarytreatment.Thefundamen-tallawregulatingpharmaceuticalsinChinaistheDrugAdministrationLaw,whichgovernsvariousdrug-relatedactivities,includingtheirdevelop-ment,registration,manufacturinganddistribu-tion.UnderthePRClegalregime,pharmaceuti-calsandmedicaldevicesarecategorisedastwodifferenttypesofproductssubjecttodifferentregulations.Detailsontheregulationofpharma-ceuticalscanbeviewedintheChambersGlobalPracticeGuideforLifeSciences.

UnderthePRClegalregime,bloodproductsreferto,inparticular,varioushumanplasmaproteinproducts,whicharegovernedasphar-maceuticals.

ProductSafetyRegulatoryRegimefor

PersonalProtectiveEquipment

“Personalprotectiveequipment”isnotadefinedlegaltermunderPRClaws.

Therearespecificrequirementsfor“speciallabourprotectionarticles”,whichincludesafe-tynets,safetyhelmets,buildingfastenersandotherproductsthatensurelaboursafety.Thecurrentregulationsonspeciallabourprotectionarticlesarelessstringentthantheregulationsformedicaldevices.Unlikemedicaldevices,busi-nessoperatorsdonotneedtoobtainspecialpermitsorlicencesfortheregistration,manufac-turingordistributionofspeciallabourprotectionarticles.Thegovernmentimplementsathird-partyvoluntarycertificationsystemforattachingsafetysignsonspeciallabourprotectionarticles,andtheproduction,circulationanduseofsuchspeciallabourprotectionarticlesaresubject

toenhancedsupervisionbyAdministrationforMarketRegulationanditslocalcounterparts(collectively,AMR)beyondordinaryproducts,bymeansofspotchecksofproductqualityandon-sitesupervisionfortheuseofsuchspeciallabourprotectionarticles.

Iftheprotectivearticlesusedbymedicalstafffallwithinthescopeofmedicaldevices,theyareregulatedasmedicaldevices.

Generallabourprotectionarticlesandotherpersonalprotectiveequipmentaredeemedtobeordinaryproductswithnospecialregulatoryrequirementsfortheirmarketing,manufacturinganddistribution.

1.2HealthcareProducts

ProductSafetyRegulatoryRegimefor

HealthcareProducts

Cosmeticsaregovernedbyadministrativeregu-lations,rangingfrommanufacturingtomarket-ing,businessoperationandpost-marketmoni-toring.TheRegulationsontheSupervisionandRegulationofCosmeticsarethemostsignificantregulationsinthehierarchy,whichapplyaClas-sificationSupervisionSystemtocosmetics:

•specialcosmetics,referringtocosmeticsthatclaimnewefficacy,mustberegisteredwiththecompetentauthoritiesbeforemanufactur-ingandimport;while

•ordinarycosmetics(cosmeticsotherthanspecialcosmetics)needonlyberecord-filed.

Biocidesfallunderthelegislativeregimeofpes-ticidesandthusmustcomplywiththestrictlyregulatedsystemforpesticides.AccordingtotheRegulationsonPesticideAdministration,forthemanufacturing,marketingandbusinessoperationofpesticides,correspondinglicencesmustbeobtainedfromthecompetentauthori-ties.Post-marketmonitoringofpesticidesisalsoahighlyregulatedarea.

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FoodandnutritionsupplementsareregulatedundertheFoodSafetyLaw.Tobespecific,foodisclassifiedaseitherconventionalfoodorspecialfood,andthelattercovershealthfood.Healthfoodreferstofoodwithspecifichealth-carefunctions,whichmeansfoodthatissuit-ableforspecificgroupsofpersonsduetoitsfunctionsforbodyregulationbutnotforthepur-poseofdiseasetreatment,andincludesnutritionsupplements.Thus,nutritionsupplementsmustfollowtheFoodSafetyLawand,meanwhile,aresubjecttospecialregulationsforhealthfood,whicharenamedtheCatalogueManagementSystemunderAdministrativeMeasuresfortheCatalogueofIngredientsandtheCatalogueofHealthcareFunctionsofHealthFood.

1.3NewProducts/TechnologiesandDigitalHealth

Certainmedicalapps,telemedicineinforma-tionsystemsandwearablesmaybeclassifiedasmedicaldevicesiftheymeetthedefinitionofamedicaldeviceasdiscussedin1.1Medical

Devices.

MedicalApps

Amedicalappisakindofmedicaldevicesoft-wareifitmeetsthedefinitionofamedicaldeviceasdiscussedin1.1MedicalDevices.Medicaldevicesoftwarecanbedividedintotwomaincategories:standalonesoftwareandsoftwarecomponents.

StandaloneSoftware

Standalonesoftwarereferstosoftwareintendedtobeusedforoneormoremedicalpurposesthatperformsthesepurposeswithoutbeingpartofahardwaremedicaldevice.Therearetwotypesofstandalonesoftware:genericstandalonesoft-wareanddedicatedstandalonesoftware.

Genericstandalonesoftware

Genericstandalonesoftwareisusuallyusedinconjunctionwithmultiplemedicaldevicesbased

onagenericdatainterface,suchasmedicalimageprocessingsoftwareandpatientmoni-toringsoftware.Genericstandalonesoftwareisgenerallyregisteredasamedicaldevice.

Dedicatedstandalonesoftware

Dedicatedstandalonesoftwareislinkedtoaspecificmedicaldevicebasedonagenericordedicateddatainterface,whichcouldberegis-teredeitherasanindependentmedicaldeviceorasapartofahardwaremedicaldevice.Ifreg-isteredasapartofahardwaremedicaldevice,itwillberegardedandregulatedasasoftwarecomponent,ratherthanasamedicaldevice.

SoftwareComponents

“Softwarecomponent”referstosoftwarethatisintendedtobeusedforoneormoremedicalpurposesandthatcontrolsordrivesahardwaremedicaldeviceorrunsonadedicated/medicalcomputingplatform.Asoftwarecomponentisacomponentofamedicaldevicethatdoesnotneedtobeindependentlyregisteredasamedi-caldevicebutshouldberegisteredalongwiththemedicaldeviceitworkswith.

Wearables

Wearablesthatmeetthedefinitionofmedicaldevicesasdiscussedin1.1MedicalDevicesareclassifiedandregulatedasmedicaldevices.Otherwise,theyareregulatedaselectricalorelectronicproducts,suchasmassagers,exer-cisemachinesandheartratemonitorsforexer-cise.

Telemedicine

Atelemedicineinformationsystemisusedfortelemedicineservices.AccordingtoGoodPrac-ticesforTelemedicineServices(forTrialImple-mentation),thetelemedicineinformationsystemshallensurethatimages,sounds,textsandothermedicalinformationrequiredinthetelemedicineservicecanbetransmittedsafelyandintime,andensurethattheimagesareclearandthat

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thedataisaccurate.Thetelemedicineinforma-tionsystemmustalsoconformtotheTechnicalGuidelinesforConstructionoftheTelemedicineInformationSystemandmeettherequirementsofclinicaldiagnosis.

Equipmentinthetelemedicineinformationsys-temthatmeetsthedefinitionofamedicaldeviceisregulatedasamedicaldevice.

Cannabidiol

Cannabidiol(CBD)isanactiveingredientofcan-nabiswhichcannotbeusedasarawmaterialforcosmeticsinaccordancewiththeListofProhib-itedRawMaterialsforCosmeticsissuedbytheNMPA.Furthermore,cannabidiolisnotlistedintheCatalogueofNarcoticDrugs,theCatalogueofPsychotropicSubstancesortheSupplemen-taryCatalogueofControlledNarcoticDrugsandPsychotropicSubstancesforNon-pharmaceuti-calUse.

1.4BorderlineProducts

MedicinesandMedicalDevices

Generally,medicinesandmedicaldevicesaretwotypesofproductswithsimilarstringentreg-ulationmethods.TheMAHofmedicinesorthemedicaldeviceregistrants/record-filingholdersareresponsibleforthewholelifecycleoftheproduct.

Inpractice,certaintypesofproductsmayhavefeaturesofbothmedicinesandmedicaldevicesandwillbecategorisedaseithermedicinesormedicaldevicesdependingonthecharacteris-ticsofsuchproducts.

•Acombinationproduct.Astoamedicalproductcontainingbothadrugandadevice(ie,acombinationproduct),applicantsshouldapplyforitsregistrationasadrugifitmainlyactsasadrugandshouldapplyforitsregis-trationasamedicaldeviceifitmainlyactsasamedicaldevice.Ifitsmajorutilitycannotbe

easilyidentified,theapplicantshouldapplytotheCentreforMedicalDeviceStandardisationAdministrationoftheNMPAinordertodefinethecharacteristicsofsuchcombinationprod-uctbeforeapplyingforitsregistration.

•Invitrodiagnosis(IVD)reagents.UnderthePRClegalregime,mostIVDreagents,includ-ingreagents,kits,calibratorsandqualitycontrolproductsusedforinvitrotestingofhumansamplesintheprocessofdiseaseprediction,prevention,diagnosis,treatmentmonitoring,prognosisobservationandhealthstatusevaluation,aredefinedasmedicaldevices,exceptforIVDreagentsforbloodsourcescreeningandIVDreagentslabelledwithradionuclides,whicharecharacterisedasdrugs.

PersonalProtectiveEquipmentand

Medicines

Personalprotectiveequipmentandmedicinesaredifferentcategoriesofproductsunderdif-ferenttypesofregulations.Asmentionedin1.1MedicalDevices,theprotectivearticlesusedbymedicalstaffthatfallwithinthescopeofmedicaldevicesareregulatedaccordingtotherulesformedicaldevices.

MedicinesandFood

Consumersmayconfusehealthfoodswithmedicinesbecausehealthfoodmayclaimcer-tainfunctionsofhealthprotection.However,theFoodSafetyLawstipulatesthatfood,includinghealthfood,excludessubstancesthatareusedforthepurposeoftreatmentandfurtherstress-esthatlabelsanddescriptionsofhealthfoodshallnotrefertoanypreventiveortherapeuticfunctionbutshallinsteadstatethattheycannotreplacemedicine.

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2.COMMERCIALISATIONANDPRODUCTLIFECYCLE

2.1DesignandManufacture

RequirementsonManufacturingMedical

Devices

Themanufactureofmedicaldeviceseitherforclinicaluseorforcommercialisationmustcom-plywiththerequirementsoftheRSAMD,the

MeasuresfortheSupervisionandAdministrationofMedicalDeviceManufacture,andGoodMan-ufacturingPracticeforMedicalDevices(“GMPforMedicalDevices”)inthePRC.GMPforMedicalDevicescontainsgeneralrequirementsregardingorganisationandpersonnel,premisesandfacilities,equipment,documentmanage-ment,designanddevelopment,purchasing,manufacturingmanagement,qualitycontrol,distributionandafter-salesservices,controlofnonconformingproducts,monitoring,analysisandremediationofadverseevents,andotherspecificrequirementsforspecificproducts,as

appendices.

Amongothers:

•formanufacturingsites,thepremisesmustmeetthemanufacturingrequirements,eg,theproductionareamustbeofsufficientcapacitytosuitthescaleofproductionandthevarie-tiesoftheproducts,andtheoveralllayoutoftheproduction,administrativeandancillaryareasmustbereasonableandtheymustnotinterferewitheachother;

•fordesignanddevelopmentplanning,amanufacturermustsetoutthedesignanddevelopmentstagesaswellasthereview,verification,validationanddesigntransferactivitiestobeperformedateachstage.Thedesignanddevelopmentinputsmustincludethefunctional,performanceandsafetyrequirementsaccordingtotheintendedpur-pose,regulatoryrequirements,riskmanage-

mentandcontrolmeasuresandotherrequire-ments.Designanddevelopmentoutputsmustmeettheinputrequirements,includingtherelevantinformationneededforpurchase,manufactureandservices,producttechnicalrequirements,etc;

•themanufacturermustkeeplegibleandcom-pleterecordsthatensurethetraceabilityofactivitiessuchasthemanufactureandqualitycontroloftheproducts;and

•unlessotherwisespecifiedbytheapplicablelawsorregulations,alltherecordsmustberetainedforaperiodatleastequivalenttothelifespanofthemedicaldeviceandfornotlessthantwoyearsfromthedateofreleaseoftheproduct.

Inadditiontotheabove-mentionedGMPrequire-ments,themanufacturerofmedicaldevicesmustobtainalicenceorrecord-filingbeforeitmanufacturesmedicaldevicesforcommerciali-sation.Therequisitepermitsformanufacturingmedicaldevicesvarybasedupontheclassifica-tionofthemedicaldevicestobemanufactured.FormanufacturingClassImedicaldevices,amanufacturingrecord-filingreceiptisrequired.FormanufacturingClassIIand/orClassIIImedi-caldevices,alicencemustbeobtained.

ContractManufacturingofMedicalDevices

Exceptforthemedicaldeviceslistedinthe

CatalogueofMedicalDevicesProhibitedfromEntrustedManufacturing,theMAHofmedicaldevicescanentrustaqualifiedthird-partyman-ufacturertomanufacturethemedicaldevices.Insuchacase,thepartiesmustenterintoanagreementtoprescribetheresponsibilitiesofeachpartyandespeciallytheresponsibilitiesandliabilitiesforproductqualityassurance.Themanufactureofamedicaldevicecanonlybeentrustedtoonemanufacturer(exceptfortheholdingcompany)duringoneperiod,andsuchentrustmentmustbefiledorregisteredtobevalidandenforceable.

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HealthcareProducts

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Alicenceformanufacturingisaprerequisiteforproductionofcosmeticsandfood.Manufac-turersofcosmeticsandfoodmustfollowtherespectivemanufacturingrequirements.

GoodManufacturingPracticeforCosmetics(“GMPforCosmetics”)isageneralguidelineforcosmeticsmanufacturerstodevelopaninternalqualitycontrolsystem,which,inturn,isthestandardforcompetentauthoritiestoinspectwhetherthemanufacturingqualifies.KeyaspectsofGMPforCosmeticsincludeorganisationandpersonnel,qualityassuranceandcontrol,managementoffactoryfacilitiesandequipment,managementofmaterialandproduct,manufacturingprocessmanagement,managementofentrustedmanufacturingandmanagementofproductsales.

Foodproductionmustconformtotherequire-mentsstipulatedbytheFoodSafetyLawandawholesetofnationalstandardsregardingfoodsafety.Keyrequirementsincludetheestablish-mentoftheinternalfoodsafetymanagementsystem,theself-inspectionsystemforfoodsafetyandimplementationofcontrolsoverrawmaterials,self-controlconcerningtheproductionprocess,safetyofequipment,storageandpack-aging,aswellasinspectionandcontroloverfin-ishedproducts,transportationanddelivery.

SpecialRegulationsforMedicalApps

Withrespecttomedicalapps,theNMPAhasissuedspecialregulationsforthemanufactureofstandalonesoftware,suchastheAppendixforStandaloneSoftwaretoGMPforMedicalDevices(the“Appendix”),andGMPforMedicalDevices–GuidelinesforOn-SiteInspectionof

StandaloneSoftware.

TheAppendixappliestostandalonesoftwareandappliesmutatismutandistosoftwarecom-ponents.AccordingtotheAppendix,thespecial

requirementscoveraspectsincludingpersonnel,equipment,designdevelopment,procurement,manufacturingmanagement,qualitycontrol,salesandafter-salesservice,andmonitoring,analysisandremediationofadverseevents.

Tobemorespecific,(i)concerningqualitycon-trol,theAppendixrequiresthatthereleaseofsoftwareproductsisdocumented,andsoftwareversionidentification,installationanduninstal-lationtesting,productintegrityinspectionandotheractivitiesrelatedtothequalitycontrolofsoftwareproductsmustalsoberecorded;and(ii)withrespecttodesignspecifications,theAppen-dixrequiresthatthesoftwaredesignspecifica-tionsandrelevantreviewrecordsareformulatedandapprovedandupdatedinduetime.

SpecialRulesandStandardsforWearables

Forwearablesthatmeetthedefinitionofmedi-caldevicesandareregulatedasmedicaldevic-es,theCentreforMedicalDeviceEvaluation(CMDE)oftheNMPAhasissuedseveraltechni-calguidelinesandproductregistrationguidanceforcertainmedicaldevicewearables,suchaspulseoximeters.

Asforwearablesthatareelectricalorelectronicproductsratherthanmedicaldevices,severalnationalstandardsonelectricalorelectronicproductsmayapply,suchasGB/T37344,GB/T37035,GB/T37037,GB/T41265,etc.

Furthermore,wearablesusingGSM/GPRS,

CDMA,CDMA1X,CDMA2000,TD-SCDMA,

WCDMAandTDLTEstandardsmustobtainCCCcertification.

2.2CorporateSocialResponsibility,the

EnvironmentandSustainability

Thereisanationaltrendtowardsstrengtheningthelegislationoncorporatesocialresponsibil-ity.Entitiesinvolvedinthelifecycleofmedicaldevicesandhealthcareproductsmustundertake

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generalstatutoryobligationsforenvironmentalprotectionundertheframeworkofEnvironmen-talProtectionLawofthePRC,suchasreduc-ingthedischargeofpollutants,andmustensuretheestablishment,operationandimprovementoftheirenvironmentalmanagementsystems;besides,themanufacturermustapplyforapol-lutantdischargepermitorfillinapollutantdis-chargeregistrationform.

Forwearablesthatareelectricalorelectronicproducts,theStateCouncilofthePRChasissuedtheRegulationontheAdministrationoftheRecoveryandDisposalofWasteElectricalandElectronicProducts,whichrequiresthattheproducersofelectricalandelectronicproducts,theconsigneesofimportedelectricalandelec-tronicproductsortheiragentsproduceorimportelectricalandelectronicproductslegallybasedonthepollutioncontrolappliedtoelectricalandelectronicproducts,adoptdesignplansfavour-abletocomprehensiveresourceutilisationandinnocuousdisposal,andusenon-toxic,non-hazardous,low-toxicityorlow-hazardmaterialsthatcanbeconvenientlyrecycled.

Inaddition,Chinaiscurrentlyestablishingstand-ardswithmorespecificrequirementsforhealth-careproductsinrespectofenvironmentalpro-tection,includingtheWaterPollutantDischargeStandardforPesticideIndustry(SecondDraftforComment)(2022),theWaterPollutantDischargeStandardforCosmeticsIndustry(DraftforCom-ment)(2010),andtheCleanerProductionStand-ardforDailyUse