NishithDesai-印度醫(yī)療器械行業(yè)-監(jiān)管、法律和稅務問題（英）-2024-WN8

MUMBAISILICONVALLEYBENGALURUSINGAPORENEWDELHINEWYORKGIFTCITYResearchMedicalDeviceIndustryinIndiaRegulatory,LegalandTaxIssuesAugust2024?NishithDesaiAssociates2024ResearchMedicalDeviceIndustryinIndiaRegulatory,LegalandTaxIssuesAugust2024DMSCode:30668.1?NishithDesaiAssociates2024Rankedasthe‘MostInnovativeIndianLawFirm’intheprestigiousFTInnovativeLawyersAsiaPaci?cAwardsformultipleyears.Alsorankedamongstthe‘MostInnovativeAsiaPaci?cLawFirm’intheseeliteFinancialTimesInnovationrankings.?NishithDesaiAssociates2024MedicalDeviceIndustryinIndia—Regulatory,LegalandTaxIssuesDisclaimerThisreportisacopyrightofNishithDesaiAssociates.Noreadershouldactonthebasisofanystatementcontainedhereinwithoutseekingprofessionaladvice.Theauthorsandthefirmexpresslydisclaimallandanyliabilitytoanypersonwhohasreadthisreport,orotherwise,inrespectofanything,andofconse-quencesofanythingdone,oromittedtobedonebyanysuchpersoninrelianceuponthecontentsofthisreport.ContactForanyhelporassistancepleaseemailusonconcierge@orvisitusat.AcknowledgementsTanyaKukadetanya.kukade@VarshaRajeshvarsha.rajesh@EshikaPhadkeeshika.phadke@Dr.MilindAntaniMilind.antani@?NishithDesaiAssociates2024ProvideduponrequestonlyMedicalDeviceIndustryinIndia—Regulatory,LegalandTaxIssuesContentsExecutiveSummaryIntroduction1356IndiaEntryStrategiesInvestmentClimateinIndiaIndia’sPost-TRIPSIntellectualPropertyEnvironment7LegalandRegulatoryRegime8A.Authorities9B.LicensesrequiredforImport,Sale,ManufactureandLoanofMedicalDevicesundertheMDR10121212C.ManufacturingMedicalDevicesinIndiaD.ImportingMedicalDevicesintoIndiaE.RegistrationofMedicalDevicesF.Manufacturing/ImportofanInvestigationalMedicalDeviceandNewInvitroDiagnosticMedicalDevice13131515G.ClinicalInvestigation/ClinicalPerformanceEvaluationH.ProductStandardsI.LabellingMedicalDeviceRules2017—AnAnalysisA.Risk-basedClassi?cationsSystemB.SingleWindowClearance2525262627C.CertaintyandRationalizationofTimelinesD.PerpetualLicensesE.ConsolidationofRegistrationCerti?cateandImportLicenseintoaSingleLicense272828F.CertaintyonConsequenceofChangeinParticularsContainedintheLicenseG.Meaningof“ChangeinConstitution”ExplainedandChangeinConstitutionRationalized?NishithDesaiAssociates2024ProvideduponrequestonlyMedicalDeviceIndustryinIndia—Regulatory,LegalandTaxIssuesH.LicenseforSaleofMedicalDevices29I.MandatoryRecallsonKnowledgeofRisktoSafety3030J.NewThresholdsforResidualShelfLifeofImportedProductsK.NewRegulatoryFrameworkforClinicalInvestigation/ClinicalPerformanceEvaluationofMedicalDevice303131L.DebarmentonAccountofSupplyofMisleadingInformationM.MovingtowardsIndependentRegulationTaxationRegimeA.DirectTaxes323242B.IndirectTaxesAnnexureA45LabellingRequirementsforMedicalDevicestobemarketedinIndiaunderMDR45AnnexureB47LabellingRequirementsforMedicalDevicesintendedforExport47AnnexureC48ParametersforClassi?cationofMedicalDevicesandIn-VitroDiagnosticMedicalDevices48AnnexureD57?NishithDesaiAssociates2024ProvideduponrequestonlyMedicalDeviceIndustryinIndia—Regulatory,LegalandTaxIssuesExecutiveSummaryIndiaiscountedamongthetop20globalmedicaldevicesmarketandisexpectedtogrowataCAGRof16.4reachUSD50billionby2030.1TheIndianmedicaldevicemarketisdominatedbyimportedproducts,whicompriseofaround80%oftotalsales.2Thedomesticcompaniesarelargelyinvolvedinmanufacturinlow-endproductsforlocalaswellasinternationalconsumption.Lately,manymultinationalcompanieshaestablishedlocalpresencebyacquiringestablisheddomesticcompaniesorstartinganewbusiness.Medicaldevicesplayarolenotonlyinscreening,diagnosingandtreatingpatientsbutalsoinrestoringpatientonormallivesandinregularlymonitoringhealthindicatorstopreventdiseases.Withtechnologicaadvancements,theroleofmedicaldevicesisnowexpandingtoimprovequalityofcareacrosseachstagofthehealthcaresector.TheIndianmedicaldevicemarketoffersagreatopportunitynotonlyofitssize,balsobecauseofencouragingpoliciesandregulationsthattheGovernmenthasintroducedtogiveafillitothemedicaldeviceindustry.Forinstance,inMarch2020,thegovernmentapproved‘Production-LinkeIncentives(PLI)SchemeforMedicalDevices.Earlierin2019,thegovernmentundertooktosetupfourmedidevicesparksinAndhraPradesh,Telangana,TamilNaduandKerala.Themedicaldeviceparksareexpecttoreducemanufacturingcosts,asthesewillbeequippedwiththenecessaryinfrastructure.TheimportanceofthemedicaldeviceindustrywascatapultedintothepubliceyeduringtheearlystageoftheCOVID-19pandemic.InMarch2020,whenCOVID-19casesfirststartedincreasinginIndia,therewacorrespondingsteepincreaseinthedemandofCOVID-19diagnostictestkitsandventilators.TheIndiamedicaldeviceindustrycomprisingofbothdomesticandforeignplayersralliedtogethertobridgethegaTheIndiangovernmentalsosteppedintoexpediteapprovalsfortestkitsandencouragemanufacturinofventilators.Overthefewpastyears,themedicaldeviceindustryhasbeencrucialinensuringasteadsupplyofdiagnostickitsandventilators.TheriseofdomesticmanufacturingintheseareashasledtothstartofanewchapterforIndia’smedicaldevicecompanies.MedicaldevicesinIndiaareregulatedundertheMedicalDeviceRules,2017.Therulesareatparwithinternationnormsandutilizetheconceptof‘risk-based’regulation.Theregulatorylicensesissuedforimport,manufactuorsaleofmedicaldevicesareperpetualinnaturewhichhelpscutdownonunnecessaryandtime-consuminpaperwork.InFebruary2020,theIndianGovernmentalsosignificantlyexpandedthescopeofIndia’medicaldeviceregulationbywayofanotification.Whentheabove-mentionednotificationcameintoeffeonApril01,2020,allmedicaldeviceswerebroughtunderthepurviewofIndia’smedicaldeviceregulatorframework,priortothenotification,only29categoriesofmedicaldeviceswereregulatedinIndia.AspartofensuringeaseofdoingbusinessinIndia,foreigndirectinvestmentinmedicaldevicemanufactursectorispermittedwithoutanypriorapprovalfromthegovernment,allowingbusinesstoquicklyscale-existingoperationsbyinfusingcapitalorengageintime-sensitivestrategicacquisitions.ThealreadyrobuintellectualpropertyrightsregimeinIndiahasbeenstrengthenedfurtherbyallowingforgrantofpatentatrademarksformedicaldevices.TheIndianGovernmenthasalsointroducedvariousfiscalmeasurestopromresearch,development,manufacturingandimportofmedicaldevices.Forinstance,theGovernmenthincentivizedscientificresearchanddevelopmentbyprovidingweighteddeductionfortheexpenseincurronthatfront.Thereisminimalornoimportdutyoncertainmedicaldevices.1Availableat:/industry/medical-devices.aspx,lastaccessedonJanuary25,2023./industry/medical-devices.aspx,lastaccessedJanuary25,2023.2?NishithDesaiAssociates2024Provideduponrequestonly1MedicalDeviceIndustryinIndia—Regulatory,LegalandTaxIssuesExecutiveSummaryHowever,likeanyothercountry,therearecertainchallengesindoingbusinessofmedicaldevicesinIndthatmustbeborneinmind.Thefirstandforemostchallengeispricecontrol.TheGovernmentofIndiacontrpricesofcertainmedicaldevicesbyeitherfixingapriceatwhichtheymaybesoldunderaformulabyrestrictingtheabilityofthemarketerofthemedicaldevicetoincreaseitspricebymorethanaprescripercentageatanygiventime.Thesecondchallengeisthepresenceofmultipleregulatorswhichmaymasimpletasks,suchasrectificationofanerroneousdeclarationonthelabel,quiteadrawn-outprocess.Thethichallengeispresenceoflawsthatrestrictmanufacturesandimportersofmedicaldevicefrompromotintheirproductsdirectlytothecustomersincertaincircumstances.Allthesechallenges,andmanymore,adetailedinthebodyofthisresearchpaper.OnemustalsonotlosesightofthefactthattheIndianconsumermindsetandlocalbusinesspracticesaruniqueandmustbecarefullystudiedwhiledevelopingabusinessmodel.Certainlaws,suchastheforeiexchangeregulationsandthetaxstatutemustalsobeassessedin-depthbecausetheyaffecttheabilityoftinvestortoinvestanddrawoutreturnsanddeterminethedegreeofprofitability.Havingsaidthat,theGovernmentremainsextremelycommittedandsensitivetothedemandsoftheindustand,infact,hasear-markedmedicaldeviceindustryasa“sun-shine”sector.ItishopedthatthisresearcpaperwillactasaguidetoeveryonewhoisinterestedindoingbusinessofmedicaldeviceinIndia.?NishithDesaiAssociates2024Provideduponrequestonly2MedicalDeviceIndustryinIndia—Regulatory,LegalandTaxIssuesIntroductionTheapproximateUSD11BillionworthIndianmedicaldevicesectorpresentsanexcitingbusinesslandscaandopportunitiesforbothmulti-nationalanddomesticplayers.Tilltheearly1990s,themedicaldevicesecwassignificantlydominatedbydomesticplayers.ButafterIndiaopenedupitsmarketsin1991,tableshaturned.Thetechnologicaladvancementandexpertisethattheglobalmarketleadersofferedhasprovedbeanadvantage.Today,India’smedicaldevicesectorisdominatedbymulti-nationalcompanies,whicisevidentfromthefactthatabout80%ofthesalesaregeneratedbyimportedmedicaldevices.Thedomesplayers,ontheotherhand,werequicktoadaptthewindsofchangeandstartedtofocusonlowcostdevicOvertheyears,manymulti-nationalshavesetupoperationsinIndia.However,thenatureofmajorityoftoperationsistoonlydistributeimporteddevicesandprovidesupportfunction.Fewmulti-nationalshavestartedomesticproductiontoo.Somemulti-nationalshavealsoenteredIndiabyacquiringdomesticmanufacturerForexample,Netherland-basedRoyalPhilipsElectronics,aleadingmanufacturerofGeneralX-RayacquirAlphaX-RayTechnologies,aleadingmanufacturerofcardiovascularX-Raysystems.Thesegmentsofthemedicaldeviceindustryareillustratedbelow:IndianMedicalDevicesIndustryConsumablesandImplantsDiagnosticImagingincludingstents,syringes,needs,catheters,suturingmaterials,bandagesanddressingincludingelectro-diagnosticapparatus,radiationapparatus,imagingpartsandaccessoriesInstrumentsandAppliancesPatientAidsandOthersincludingsurgicalandnon-surgicalequipmentandotherinstrumentsandsuppliesincludinghearingaids,prostheticsandorthotics,pacemakersandothersSource:DeloitteMedicalDevicesReport11MedicalDevicesMakinginIndia—ALeapforIndianHealthcare,Delloite,availableat:/in/en/pages/life-sciences-anhealthcare/articles/medical-devices-making-in-india.html,lastaccessedonJanuary25,2023.?NishithDesaiAssociates2024Provideduponrequestonly3MedicalDeviceIndustryinIndia—Regulatory,LegalandTaxIssuesIntroductionThesectorisatpresentgrowingataround35.4%CompoundAnnualGrowthRate(“CAGR”)foraplethorofreasons.2Asignificantpercentageofpurchasersofmedicaldevicesareprivatemedicalinstitutionsanhospitals.DuetoincreasedcompetitioninTierIcities,privateenterpriseshavestartedtofocusonTierIandTierIIIcities,amarketwhichisuntilnowuntappedinIndia.Asprivateenterprisesexpandinlesseexploredmarkets,thedemandformedicaldeviceswillexpandproportionally.Otherreasonsforstrongrowthprospectsoftheindustryare:§?Economicgrowthleadingtohigherdisposableincomes§?Increasedpublicspendinginhealthcare§?Increasedpenetrationofhealthinsurance§?Improvingmedicalinfrastructure§?Increasingaffordabilityduetogrowingincome§?Increasingnumberofailments§?Increasingdemanddueto“Medicaltourism”ThesectorisalsowitnessingstrongForeignDirectInvestments(“FDI”)inflows,whichreflectstheconfidencofglobalplayersintheIndianmarket.Asperofficialdata,themedicalandsurgicalequipmentsectorreceivatotalofINR14,526Crore(approx.USD2.3Billion)betweenApril2000toSeptember2021.3By2025,theIndia4marketformedicalequipmentispredictedtoincreasetoUSD50billion.ThemajorplayersinIndianmarketare(innoparticularorder):HindustanSyringes&MedicalDeviceOptoCircuits(India),WiproGEHealthcare,3M,Medtronic,Johnson&Johnson,BectonDickinson,AbboVascular,Bausch&Lomb,Baxter,ZimmerIndia,EdwardsLifeSciences,St.JudeMedical(nowapartofAbboSmith&Nephew,Cochlear,Stryker,Baxter,BostonScientific,BPLHealthcareIndia,SushrutSurgicalTrivitronDiagnostics,AccurexBiomedical,BioporeSurgicals,EndomedTechnologies,HDMedicalServic(India),EasternMedikit,Harsoriahealthcare,NidhiMeditechSystem,PhilipsMedical,WiproTechnologHCLTechnologiesandTexasInstruments.SomeofthemajorindustryassociationsincludeAdvancedMedicalTechnologyAssociation(ADVAMEDAssociationofIndianMedicalDeviceIndustry(AIMED),MedicalTechnologyAssociationofIndia(MTai),APacificMedicalTechnologyAssociation(APACMed),NATHEALTH,AssociationofDiagnosticsManufacturofIndia,AllIndiaPlasticsManufacturers’Association,MedicalDisposablesManufacturersAssociatioSocietyofBiomaterials&ArtificialOrgans,NationalBiomedicalEngineeringSocietyandMedicalSurgicandHealthcareIndustryTradeAssociation.AllmultinationalslookingtoinvestintheIndianmedicaldevicesectormuststrategizetheirentryonthbasisofcertainkeyfactorswhichwillinfluenceprofitabilityoftheinvestment.Thesekeyfactorsarelistanddiscussednext.234/industry/medical-devices.aspx,lastaccessedJanuary25,2023..in/sites/default/?les/FDI_Factsheet_Spetember-21.pdf,lastaccessedJanuary31,2023./industry/medical-devices.aspx,lastaccessedJanuary25,2023.?NishithDesaiAssociates2024Provideduponrequestonly4MedicalDeviceIndustryinIndia—Regulatory,LegalandTaxIssuesIndiaEntryStrategiesMultinationalmedicaldevicecompaniesorinvestorsseekingtodobusinesswithIndianmedicaldeviccompaniesneedtoappraiseandstructuretheiractivitiesonthreepillars:StrategyLawTax§?ObservingtheeconomicandpoliticalenvironmentinIndiafromtheperspectiveoftheinvestment§?ExchangeControlLaws:PrimarilytheForeignExchangeManagementAct,1999andnumerouscirculars,notificationsandpressnotesissuedunderthesame§?DomesticTaxationLaws:TheIncomeTaxAct,1961;GoodsandServiceTaxcustomslaw.§?InternationalTaxTreaties:TreatieswithfavorablejurisdictionssuchasMauritius,Cyprus,SingaporeandthNetherlands§?UnderstandingtheabilityofthemultinationalcompanyoraninvestortocarryoutoperationsinIndia,thelocationofitscustomers,thequalityandlocationofitsworkforce§?CorporateLaws:PrimarilytheCompaniesAct,1956,theCompaniesAct,2013andtheregulationslaiddownbytheSecuritiesandExchangesBoardofIndia(“SEBI”)§?TostrategizethebusinessmodelbyidentifyingthecorrectmodalitytodobusinessinIndia§?SectorSpecificLaws:Drugs&CosmeticsAct,1940,theDrugsRules,1945,theMedicalDeviceRules,2017,thePatentsAct,1970andotherlegislations,regulationsandguidelinesthataffectthemedicaldevicesindustryThehealthcaresectorinIndiahaslongbeenconservativeaboutforeigninvestmentstatingconcernsofforeiginfluenceoverpublic-focusedsectorsuchashealthcare.However,inrecenttimes,thereisgrowinggovernmenandpopularsupportforforeigninvestmentinallsectors,includinghealth.Itisalsoimportanttobefamiliarofthelegalandregulatoryframeworkgoverningmedicaldevices.Themedideviceindustryistightlyregulated,andanynon-compliancemayresultinpenalty,closureofbusinesaswellascriminalprosecutionofthemanagement(inextremecases).Ifamulti-nationalcompanyisoperatiawhollyownedsubsidiaryinIndia,itmustensurethatthesubsidiaryiscompliantwithIndia’smedicadeviceregulatoryframeworkandotherproductliabilitylegislationtoavoidanyunpleasantlegalproceedinMulti-nationalcompaniesshouldalsokeepaneyeontheexchangecontrollawsastheygovernhowprofmadebythecompanycanberealizedoutofIndiaandconsiderstructuringinvestmentsthroughfavorabtaxjurisdictions,asitmayleadtosignificanttax-savings.?NishithDesaiAssociates2024Provideduponrequestonly5MedicalDeviceIndustryinIndia—Regulatory,LegalandTaxIssuesInvestmentClimateinIndiaByandlargeFDIisnowpermittedinalmostallthesectorsinIndiawithoutobtainingpriorregulatorapprovals(i.e.underthe“automaticroute”)barringsomeexceptionalcaseslikedefense,housingandreaestate,printmedia,etc.(referredtoasthe“negativelist”).IftheFDIisnotinaccordancewiththeprescribguidelinesoriftheactivityfallsunderthenegativelist,priorapprovalhastobeobtainedfromthegovernme(“approvalroute”).FDIinmanufacturingofmedicaldevicesispermittedtotheextentof100%undertheautomaticroute.FortlimitedpurposeofFDIPolicy,Medicaldeviceisdefinedasfollows;Medicaldevicemeans;a.Anyinstrument,apparatus,appliance,implant,materialorotherarticle,whetherusedaloneorincombination,includingthesoftware,intendedbyitsmanufacturertobeusedspecificallyforhumabeingsoranimalsforoneormoreofthespecificpurposesof–i.Diagnosis,prevention,monitoring,treatmentoralleviationofanydiseaseordisorder;ii.Diagnosis,monitoring,treatment,alleviationorassistancefor,anyinjuryordisability;iii.Investigation,replacementormodificationorsupportoftheanatomyorofaphysiologicalprocesiv.Supportingorsustaininglife;v.Disinfectionofmedicaldevices;vi.Controlofconception,vii.Andwhichdoesnotachieveprimaryintendedactioninoronthehumanbodyoranimalsbyanpharmacologicalorimmunologicalormetabolicmeans,butwhichmaybeassistedinitsintendfunctionbysuchmeans;b.Anaccessorytosuchaninstrument,apparatus,appliance,materialorotherarticle;c.In-Vitrodiagnosticdevicewhichisareagent,reagentproduct,calibrator,controlmaterial,kit,instrumeapparatus,equipmentorsystem,whetherusedaloneorincombinationthereofintendedtobeusedfoexaminationandprovidinginformationformedicalordiagnosticpurposesbymeansofexaminatio1ofspecimensderivedfromthehumanbodiesoranimals.1DepartmentofIndustrialPolicyandPromotion;PressNote1(2018);January23,2018.?NishithDesaiAssociates2024Provideduponrequestonly6MedicalDeviceIndustryinIndia—Regulatory,LegalandTaxIssuesIndia’sPost-TRIPSIntellectualPropertyEnvironmentInMarch2005,India’spatentlawwasamendedtoincorporateIndia’sobligationsunderWorldTradeOrganization(WTO)regulationsand,specifically,theTradeRelatedAspectsofIntellectualPropertyRighAgreement(“TRIPS”).PriortotheadoptionofTRIPS,protectionofintellectualpropertyrights(“IPRs”inIndiawereofconcerntoglobalmedicaldevicecompaniesseekingtoenterIndia.Post-TRIPS,Indiahawellestablishedstatutory,administrative,andjudicialframeworktosafeguardIPRs.Apatentedinventi(whichincludesmedicaldevices)isnowgiven20yearsofprotectioninIndia.Well-knowninternationatrademarkssuchasVolvoandWhirlpoolhavebeenprotectedinIndiathroughjudicialdecisionsevenwhtheywerenotregisteredinIndia.Computersoftwarecompanieshavesuccessfullycurtailedpiracythroughcourtorders.Computerdatabasesasoftwareprograms,whicharewidelyusedbythemedicaldevicesindustry,havebeenprotectedundercopyrighComputerprogramshavingtechnicalapplicationtoindustryandcomputerprogramsincombinationwithardwarecannowbepatentedinIndia.Thoughtradesecretsandknow-howarenotprotectedbyanylegislatitheyareprotectedunderthecommonlawandthroughcontractualobligations.Thecourts,onthegrouofbreachofconfidentiality,accordprotectiontoconfidentialinformationandtradesecrets.?NishithDesaiAssociates2024Provideduponrequestonly7MedicalDeviceIndustryinIndia—Regulatory,LegalandTaxIssuesLegalandRegulatoryRegimeTheMedicalDeviceRules,2017(“MDR”),issuedundertheDrugsandCosmeticsAct,1940(“DCA”),constituteIndia’sprimarymedicaldeviceregulatoryframework.TheMDRregulatesthefollowingcategoriesofsubstanceasmedicaldevices–a.Specificdevicesintendedforinternalorexternaluseinthediagnosis,treatment,mitigationorpreventiofdiseaseordisorderinhumanbeingsoranimalswhicharenotifiedbythegovernmentfromtimetotiundertheDCA;b.SpecificsubstancesintendedtoaffectthestructureoranyfunctionofthehumanbodywhicharenotifiebythegovernmentundertheDCA.Atpresent,thesubstancesnotifiedaremechanicalcontraceptives(e.g.condoms,intra-uterinedevices,tubalrings),insecticidesanddisinfectants;c.Surgicaldressings,surgicalbandages,surgicalstaples,surgicalsutures,ligatures,bloodandbloodcomponentcollectionbagwithorwithoutanticoagulant;d.Substancesusedforinvitrodiagnosis.AtthetimetheMDRcameintoeffectonJanuary1,2018,15medicaldeviceswereregulatedundertheMDwhile8otherswereregulatedasdrugs.Sincethen,theGovernmenthasnotified14additionalmedicaldeviceAll14devices(exceptultrasoundequipment)arepresentlyregulatedundertheMDR.Thecompletelisof37productsspecifiedhereiscapturedinAnnexureA.TheslowpaceofbringingmedicaldevicesunderthepurviewoftheMDRhasbeenaconcernfortheindustrThereareover1700typesofmedicaldevicesintheglobalmarket,1outofwhichonly28werespecificalnotifiedundertheMDR.Toremedythis,theMinistryofHealthandFamilyWelfare(“HealthMinistryissuedanotificationonFebruary11,2020,effectivelybringingallmedicaldevicesinIndiaunderregulatioftheMDR.Itisnoteworthythatthemannerinwhichallmedicaldeviceshavebeenbroughtunderregulatiisnotbynotifyingeachindividualcategoryofmedicaldevice,butrathernotifyingacatch-alldefinitioofmedicaldeviceasfollows:1ArticleonTechnologicalInnovation:ComparingDevelopmentofDrugs,Devices,andProceduresinMedicine,availableat:https://www.ncbi.nl/books/NBK222708,lastaccessedJanuary30,2023.?NishithDesaiAssociates2024Provideduponrequestonly8MedicalDeviceIndustryinIndia—Regulatory,LegalandTaxIssuesLegalandRegulatoryRegime“Alldevicesincludinganinstrument,apparatus,appliance,implant,materialorotherarticle;whetherusedaloneorincombination,includingasoftwareoranaccessory,intendedbyitsmanufacturertobeusedspeciallyforhumanbeingsoranimalswhichdoesnotachievetheprimaryintendedactioninoronhumanbodyoranimalsbyanypharmacologicalorimmunologicalormetabolicmeans,butwhichmayassistinitsintendedfunctionbysuchmeansforoneormoreofthespecificpurposesof—i.Diagnosis,prevention,monitoring,treatmentoralleviationofanydiseaseordisorder;ii.Diagnosis,monitoring,treatment,alleviationorassistancefor,anyinjuryordisability;iii.Investigation,replacementormodificationorsupportoftheanatomyorofaphysiologicalprocess;iv.Supportingorsustaininglife;v.Disinfectionofmedicaldevices;andvi.Controlofconception.”MedicaldevicesarecategorizedintooneoffourclassesundertheMDR-onthebasisofincreasingriskfroClassAtoClassD.Asaresult,regulatorycompliancerequirementsforClassDdevicesaremorestringenthanthoseofClassAdevices.TheDCAandMDRcollectivelyseekto:§?Regulatetheimport,manufacture,distributionandsaleofmedicaldevices.§?Prescribequalitycontrolrequirementsinrespectofmedicaldevices.A.AuthoritiesTheCentralGovernmentandtheStateGovernmentsareresponsiblefortheenforcementoftheDCA.ThCentralDrugsStandardControlOrganization(“CDSCO”),headedbytheDrugsControllerGeneralofInd(“DCGI”)isprimarilyresponsibleforcoordinatingtheactivitiesoftheStateDrugsLicensingAuthoritiesformulatingpolicies,andensuringuniformimplementationoftheDCAandMDRthroughoutIndiaThedivisionofresponsibilitiesundertheMDRbetweenthecentralandstateauthoritiesarecapturedbelI.DCGI(CentralLicensingAuthority)Apartfromco-ordinationwithstatelicensingauthorities,theDCGIisresponsibleforhandlingmattersofa.ImportofallClassesofmedicaldevices;b.manufactureofClassesCandDdevices;c.clinicalinvestigationandapprovalofinvestigationalmedicaldevices;andd.clinicalperformanceevaluationandapprovalofnewinvitrodiagnosticdevices.?NishithDesaiAssociates2024Provideduponrequestonly9MedicalDeviceIndustryinIndia—Regulatory,LegalandTaxIssuesLegalandRegulatoryRegimeII.StateDrugController(StateLicensingAuthority)TheStateDrugController(bywhatevernamecalled)isresponsibleforhandlingmattersof:a.Manufacture(forsaleordistribution)ofclassesAandBdevices;b.issuanceoflicenseorregistrationcertificate,asapplicable,forsale,stocking,exhibitionorofferforsaordistributionofmedicaldevicesofallclassesTheMDRhasalsointroducestwonewbodies—theNationalAccreditationBodyandNotifiedBodies.AnotifiedbodyisresponsibleforcarryingoutauditsofmanufacturingsitesofallclassesofmedicaldevictoverifyconformancewiththeQualityManagementSystem(discussedlater).AnentitywiththerelevanexperienceandqualificationasprescribedundertheMDRcanapplytotheCentralLicensingAuthorityfoappointmentasanotifiedbody.TheNationalAccreditationBodyisanentitynotifiedbytheCentralGovernment,whichfulfilscertaincriterspecifiedbythegovernmentfromtimetotime.Currently,theQualityCouncilofIndiaactsastheNationAccreditationBodyandcarriesoutthefunctionsprescribedundertheMDR.TheNationalAccreditationBodylaysdow