環(huán)球律師事務(wù)所-全球法律指南：生命科學(xué)2023之中國篇（英）

CHAMBERSGLOBALPRACTICEGUIDES

LifeSciences

2023

Definitivegloballawguidesoffering

comparativeanalysisfromtop-ranked

lawyers

China:Law&Practice

AlanZhou,CocoFan,StephanieWang

andXuchunHuang

GlobalLawOffice

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LawandPractice

Contributedby:

AlanZhou,CocoFan,StephanieWangandXuchunHuang

GlobalLawOffice

Contents

1.LifeSciencesRegulatoryFrameworkp.6

1.1LegislationandRegulationforPharmaceuticalsandMedicalDevicesp.6

1.2ChallengingDecisionsofRegulatoryBodiesThatEnforcePharmaceuticalsandMedicalDevicesRegulationp.7

1.3DifferentCategoriesofPharmaceuticalsandMedicalDevicesp.7

2.ClinicalTrialsp.7

2.1RegulationofClinicalTrialsp.7

2.2ProcedureforSecuringAuthorisationtoUndertakeaClinicalTrialp.8

2.3PublicAvailabilityoftheConductofaClinicalTrialp.8

2.4RestrictiononUsingOnlineToolstoSupportClinicalTrialsp.9

2.5UseofDataResultingFromtheClinicalTrialsp.9

2.6DatabasesContainingPersonalorSensitiveDatap.9

3.MarketingAuthorisationsforPharmaceuticalorMedicalDevicesp.9

3.1ProductClassification:PharmaceuticalorMedicalDevicesp.9

3.2GrantingaMarketingAuthorisationforBiologicMedicinalProductsp.10

3.3PeriodofValidityforMarketingAuthorisationforPharmaceuticalorMedicalDevicesp.10

3.4ProcedureforObtainingaMarketingAuthorisationforPharmaceuticalandMedicalDevicesp.10

3.5AccesstoPharmaceuticalandMedicalDevicesWithoutMarketingAuthorisationsp.12

3.6MarketingAuthorisationsforPharmaceuticalandMedicalDevices:OngoingObligationsp.12

3.7Third-PartyAccesstoPendingApplicationsforMarketingAuthorisationsforPharmaceuticalandMedical

Devicesp.13

3.8RulesAgainstIllegalMedicinesand/orMedicalDevicesp.13

3.9BorderMeasurestoTackleCounterfeitPharmaceuticalandMedicalDevicesp.13

4.ManufacturingofPharmaceuticalandMedicalDevicesp.14

4.1RequirementforAuthorisationforManufacturingPlantsofPharmaceuticalandMedicalDevicesp.14

5.DistributionofPharmaceuticalandMedicalDevicesp.15

5.1WholesaleofPharmaceuticalandMedicalDevicesp.15

5.2DifferentClassificationsApplicabletoPharmaceuticalsp.15

6.ImportationandExportationofPharmaceuticalsandMedicalDevicesp.15

6.1GoverningLawfortheImportationandExportationofPharmaceuticalDevicesandRelevantEnforcement

Bodiesp.15

6.2ImporterofRecordofPharmaceuticalandMedicalDevicesp.16

6.3PriorAuthorisationsfortheImportationofPharmaceuticalsandMedicalDevicesp.16

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6.4Non-tariffRegulationsandRestrictionsImposedUponImportationp.16

6.5TradeBlocsandFreeTradeAgreementsp.17

7.PharmaceuticalandMedicalDevicePricingandReimbursementp.17

7.1PriceControlforPharmaceuticalsandMedicalDevicesp.17

7.2PriceLevelsofPharmaceuticalorMedicalDevicesp.18

7.3PharmaceuticalsandMedicalDevices:ReimbursementFromPublicFundsp.18

7.4Cost-BenefitAnalysesforPharmaceuticalsandMedicalDevicesp.18

7.5RegulationofPrescriptionsandDispensingbyPharmaciesp.19

8.DigitalHealthcarep.19

8.1RulesforMedicalAppsp.19

8.2RulesforTelemedicinep.20

8.3Promotingand/orAdvertisingonanOnlinePlatformp.20

8.4ElectronicPrescriptionsp.20

8.5OnlineSalesofMedicinesandMedicalDevicesp.21

8.6ElectronicHealthRecordsp.21

9.PatentsRelatingtoPharmaceuticalsandMedicalDevicesp.22

9.1LawsApplicabletoPatentsforPharmaceuticalandMedicalDevicesp.22

9.2SecondandSubsequentMedicalUsesp.23

9.3PatentTermExtensionforPharmaceuticalsp.23

9.4PharmaceuticalorMedicalDevicePatentInfringementp.23

9.5DefencestoPatentInfringementinRelationtoPharmaceuticalsandMedicalDevicesp.24

9.6ProceedingsforPatentInfringementp.25

9.7ProceduresAvailabletoaGenericEntrantp.26

10.IPOtherThanPatentsp.26

10.1CounterfeitPharmaceuticalsandMedicalDevicesp.26

10.2RestrictionsonTradeMarksUsedforPharmaceuticalsandMedicalDevicesp.27

10.3IPProtectionforTradeDressorDesignofPharmaceuticalsandMedicalDevicesp.27

10.4DataExclusivityforPharmaceuticalsandMedicalDevicesp.27

11.COVID-19andLifeSciencesp.27

11.1SpecialRegulationforCommercialisationorDistributionofMedicinesandMedicalDevicesp.27

11.2SpecialMeasuresRelatingtoClinicalTrialsp.27

11.3EmergencyApprovalsofPharmaceuticalsandMedicalDevicesp.28

11.4FlexibilityinManufacturingCertificationasaResultofCOVID-19p.28

11.5Import/ExportRestrictionsorFlexibilitiesasaResultofCOVID-19p.28

11.6DriversforDigitalHealthInnovationDuetoCOVID-19p.28

11.7CompulsoryLicensingofIPRightsforCOVID-19-RelatedTreatmentsp.29

11.8LiabilityExemptionsforCOVID-19TreatmentsorVaccinesp.29

11.9RequisitionorConversionofManufacturingSitesp.29

11.10ChangestotheSystemofPublicProcurementofMedicinesandMedicalDevicesp.29

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Contributedby:AlanZhou,CocoFan,StephanieWangandXuchunHuang,GlobalLawOffice

GlobalLawOffice(GLO)hasbecomeoneofthelargest,leadingChineselawfirms,withmorethan500lawyerspractisinginitsBeijing,Shanghai,ShenzhenandChengduoffices.ItslifesciencesandhealthcarepracticegroupwasoneofthefirstinChinaandprovides“one-stop”legalservicesforeveryareaoftheindustry,in-cludingM&A,investmentandfunding,licenceinandout,dailyoperation,IPprotection,andad-viceoncompliance,includinginternalandgov-ernmentinvestigationsaswellasanti-bribery

mattersanddisputesettlement.Underachang-ingregulatoryenvironment,GLO’steamhastheperfectcombinationofinternationalexperienceandlocalknowledgetosupportvariousinnova-tionorpilotprojects,includingdigitalhealthcareandMAH/cMAHtrialcases.Theteampartici-patesintheformulationoflocalcodesofcon-ductandbenchmarkpolicies/rules,andalsoco-operatescloselywithassociationssuchastheCPIA,theRDPACandtheACCP.

Authors

AlanZhouistheleadingpartnerofthelifesciencesandhealthcarepracticegroupatGlobalLawOffice,andhasastrongbackgroundinthearea,routinelyrepresenting

multinationalcorporations,well-knownChinesestate-ownedandprivateenterprises,andprivateequity/venturecapitalfunds.Asaparticipantoranexternalcounsel,Alanhasbeenengagedbylocalauthoritiesandindustrialassociationstoadviseonlegislationandindustrialstandardsinthelifesciencesandhealthcareindustry,includingguidelinesoncomplianceandriskcontrol,e-healthcare,medicalinsurancereformandmedicalrepresentativeadministration.Hehasbeenwidelypublishedbothathomeandabroad.

CocoFanisapartnerinthelifesciencesandhealthcarepracticegroupatGlobalLawOffice,andspecialisesincorporate,compliance,private

equityandventurecapital,andM&A.Herexperiencecoversprescriptionmedicine,over-the-countermedicine,contractresearchorganisations,medicaldevices,bio-pharmaceuticals,healthfoods,clinicalsupply,vaccines,animalhealthandhospitals.Cocohasadvisedmultinationalandprivatecompaniesandinvestorsonriskassessmentorhealthchecks,andontailoredcompliancetraining,includinganti-corruption,antitrustandpromotion.Shealsoadvisesontheestablishmentofindustrialcompliancemanagementstandardsforpharmaceuticalsandmedicaldevices.

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StephanieWangisanofcounselinthelifesciencesandhealthcarepracticegroupatGlobalLawOffice,andhasmorethantenyears’experience.She

hasbeenactivelyinvolvedinadvisingmultinationalpharmaceuticalandmed-techcompaniesontheircorporategovernance,dailyoperationandcompliance.Stephaniehasextensiveknowledgeandexperienceinthelifesciencesandhealthcareindustry,androutinelyadvisesclientsonavarietyofcommercialagreementsrelatingtoR&D,licensing,marketingauthorisationsandthemanufacturing,distributionandpromotionofmedicalproducts.Shehasalsoworkedwithnotableprivateequityinstitutionsoninvestmentinvariouspharmaceuticalenterprises.

XuchunHuang(Charlene)isapartneratGlobalLawOfficewhospecialisesincross-borderacquisitionsandforeigninvestment,andhasin-depthexperienceinadvising

multinationalcompaniesongeneralcorporate,cybersecurityanddatamanagementmatters.Herclientsareinthehealthcareindustriesandhertransactionsincludegreenfieldforeigninvestmentintheformofjointventuresorwhollyforeign-ownedenterprises,acquisitionsofequityinterestsinChinesestate-ownedorprivatecompanies,therestructureorintegrationofChina-basedbusinessesofmultinationalcompanies,strategic

co-operation,etc.

GlobalLawOffice

36thFloor

ShanghaiOneICC

No.999MiddleHuaiHaiRoad

XuhuiDistrict

Shanghai200031

China

Tel:+862123108200

Fax:+862123108299

Email:Alanzhou@

Web:

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1.LifeSciencesRegulatoryFramework

1.1LegislationandRegulationforPharmaceuticalsandMedicalDevicesLegislationandRegulations

TheprimarystatuteregulatingpharmaceuticalsinChinaistheDrugAdministrationLaw(DAL).Togetherwithitsimplementingrules,referredtoastheDALImplementingRegulations,theDALgovernsvariousdrug-relatedactivities,includingdrugdevelopment,registration,manufacturinganddistribution.

InordertoaddressstatutoryrequirementsundertheDALforeachoftheseactivities,GxP(goodpractice)rulesonlaboratory,clinicaltrials,man-ufacturing,distributionandpharmacovigilance(PV)havealsobeenenacted,aswellasadmin-istrativemeasuresonmatterssuchasdrugreg-istration,manufacturing,distributionandrecall.Product-specificlaws,rulesandguidelines,suchastheVaccineAdministrationLawandtheAdministrativeMeasuresonBloodProducts,alsoapplytotherespectiveproducts.

TheRegulationsfortheSupervisionandAdmin-istrationofMedicalDevices(RSAMD)havebeenenactedtosetuptheregulatoryframeworkfortheadministrationofmedicaldevices.Thedevelopment,registration/filing,manufactur-inganddistributionofmedicaldevicesare,likepharmaceuticals,regulatedbyGxPrulesandadministrativemeasures.Product-specificrulesandguidelineshavealsobeenreleasedandimplemented.

RSAMDwereamendedin2021toofficiallyincorporatemarketingauthorisationholder(MAH),conditionalapproval,emergencyuse,deviceuniqueidentification,etc,intotheregula-toryframeworks.RSAMD2021alsosignificantly

increaseadministrativepunishmentforviolationandimposelegalliabilitiesonthelegalrepre-sentativesandpersonsinchargeoftheentitiesviolatingRSAMD.Furthermore,theAdministra-tiveMeasuresontheRegistrationandRecord-filingofMedicalDevices(“DeviceRegistrationMeasures”)andtheAdministrativeMeasuresontheRegistrationandRecord-filingofInVit-roDiagnosis(IVD)ReagentswerereleasedtorespectivelyupdateandspecifytheregulatoryprocedureandrequirementsformedicaldeviceandIVDreagentregistrationandfiling.

RegulatoryBodies

StateAdministrationforMarketRegulation

(SAMR)

TheSAMRistheauthorityonthenationallevelforthemarketsupervision,administrationandlawenforcementofpharmaceuticalsandmedi-caldevices,intheareasofanti-monopoly,prod-uctqualitysafety,foodsafety,IP,faircompe-titionandcommercialbribery,theissuanceofbusinessregistrations,andcertificationsandaccreditations,amongotherthings.TheSAMRisaministry-levelgovernmentagencydirectlyundertheStateCouncil.

NationalMedicalProductsAdministration

(NMPA)

Asanationalbureauoperatingunderthesuper-visionoftheSAMR,theNMPAregulatestheregistration,post-marketriskmanagement,administrationofsafetyandquality,formulationofindustrial/nationalstandards,andsupervisionandinspectionofpharmaceuticalsandmedicaldevices.

TheNMPAalsosupervisespermit/filingreceiptissuanceandlawenforcementonpharmaceuti-calsandmedicaldevicesontheprovinciallevel,whilethelocaladministrationsformarketregu-lationareinchargeofcertainpermitissuance

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andlawenforcementonpharmaceuticalsandmedicaldevicesonthecityandcountylevels.

NationalHealthCommission(NHC)

TheNHCisaconstituentdepartmentoftheStateCouncilandismainlyresponsiblefornationalhealthpolicies,thereformofthemedicalandhealthcaresystem,diseasepreventionandcon-trol,nationaldrugpolicies,andthenationalbasicdrugsystem.TheNHCsupervisestheNationalAdministrationofTraditionalChineseMedicine.

NationalHealthcareSecurityAdministration

(NHSA)

TheNHSAismainlyresponsiblefortheprepara-tionandimplementationofregulationsandpoli-ciesrelatedtobasicmedicalinsurance(BMI),includingpoliciesregardingreimbursement,pricingandprocurementforpharmaceuticalsandmedicalservices.TheNHSAisasub-min-istry-levelgovernmentagencydirectlyunderthe

StateCouncil.

1.2ChallengingDecisionsofRegulatoryBodiesThatEnforcePharmaceuticalsandMedicalDevicesRegulation

Thedecisionsoftheregulatorybodiesthatapplyandenforceregulationsofpharmaceuticalsandmedicaldevicescanbechallengedthroughanadministrativerevieworadministrativelitigation;theseproceduresalsoapplyingeneralvis-à-visadministrativeregulatorybodiesforotherregu-latedproducts.

Citizensorlegalentitieswhowishtochallengeregulatorybodydecisionsmayfirstapplyforadministrativereview.Iftheyrefusetoacceptdecisionsmadebythereviewingbody,theymayfilealawsuitincourt,unlesstheadministrativereviewdecisionsarefinalasprescribedbylaw.Alternatively,theymayinstituteproceedingsdirectlywithacourt,exceptincertaincircum-

stanceswherelawsandregulationsprovidethattheymustapplyforanadministrativereviewfirst.Oncethecourthasacceptedthecase,citizensorlegalentitiesmaynolongeraskforanadmin-istrativereview.

1.3DifferentCategoriesofPharmaceuticalsandMedicalDevicesPharmaceuticals

TheDALclassifiesdrugsasprescriptiondrugsandnon-prescription(over-the-counter–OTC)drugs,andtheyareregulateddifferently.Apatientmustpresentprescriptionswhenpur-chasingprescriptiondrugs,whileOTCdrugscanbeboughtwithoutprescriptions.ChinafurthersubdividesOTCdrugsintoClassAandClassB,accordingtotheirsafetylevel.

MedicalDevices

TheRSAMDclassifymedicaldevicesintoClassI,ClassIIandClassIIIaccordingtotheirrisklevelsandexpectedpurposes,structuralfea-tures,methodsofuseandotherqualities.ClassIIImedicaldevicesarethosewiththehighestrisklevel,andtheirsafetyandeffectivenessshouldbeensuredbystrictcontrolandregulation.

2.ClinicalTrials

2.1RegulationofClinicalTrials

Clinicaltrialsforpharmaceuticalsareregulatedbylawsandanarrayofguidanceandtechnicalreviewstandards.Specifically,theDALandtheAdministrativeMeasuresforDrugRegistration(2020Revision)establishtheprimaryprinciplesandstatutoryrequirementsforclinicaltrials.GuidanceandtechnicalreviewstandardssuchasGoodClinicalPractice(GCP)forDrugTrialsandPharmaceuticalResearchInformationGuideforphaseIIIClinicalTrialsofInnovativeDrugs(ChemicalDrugs)provideguidancedetailingthe

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obligationsofthepartiesinvolved,operationalprocedures,technicalrequirements,etc.

Likewise,forclinicaltrialsformedicaldevices,theRSAMDandDeviceRegistrationMeasuressetoutthelegalframeworkonwhetherandhowclinicaltrialsofmedicaldevicesshouldbecon-ducted,whileanarrayofreviewstandardsandguidancesuchasGCPforMedicalDevicesTri-alsfurtherspecifyoperationguidanceandtech-nicalrequirementsforconductingclinicaltrials.ItisnoteworthythatGCPforMedicalDevicesTrialswasamendedin2022tobeconsistentwiththelatestregulatoryframeworkofmedi-caldevices.ForIVDreagents(aspecialtypeofmedicaldevices),theNMPApublishedasepa-rateguidelinetoprovidespecialprinciplesforIVDclinicaltrials.

2.2ProcedureforSecuringAuthorisationtoUndertakeaClinicalTrial

Clinicaltrialsfordrugsaregenerallyrequiredbeforethesponsorappliesformarketingauthor-isations,unlessotherwiseexemptedbylaw(suchascertaingenericdrugsandIVDadmin-istratedunderdrug-relatedlaws).Beforeaclini-caltrialcanbeconducted,itmustbeauthorisedbytheCentreforDrugEvaluation(CDE)oftheNMPA.Thegeneralstepsforsecuringclinicaltrialauthorisationareasfollows:

?areviewbyanethicalcommitteepriortoinitiation;

?asponsormayneedtoapplyforapre-con-sultationmeetingwiththeNMPA;

?thesponsormayconductaclinicaltrialforapharmaceuticalifithasnotreceivedanyobjectionorqueryfromtheCDEwithin60daysofthedatetheclinicaltrialapplicationisaccepted;

?ifthereisnoobjectionfromtheCDE,thesponsormayimplementtheclinicaltrialat

theconclusionofthe60-dayperiod–ifthesponsorisrequiredtosubmitsupplementarydocuments,the60-dayreviewperiodwillbere-calculated;and

?iftheCDEissuesanobjectiontothesponsor,thesponsormayreplyinwritingwithregardstoallissuesraisedbytheCDEandreap-plyforapprovaloftheclinicaltrial.TheCDEwillfurtherreviewanddeterminewhethertoapprovethatclinicaltrialwithin60daysofreceivingthereapplication,andthesponsorisonlyallowedtoimplementtheclinicaltrialuponreceiptoftheCDE’swrittenapproval.

Generally,clinicaltrialrequirementsformedicaldevicesaredividedaccordingtorelevantclas-sification.Specifically,ClassImedicaldevicesareexemptedfromclinicalevaluations.Aclinicalevaluationorevenclinicaltrialscouldbetrig-geredforClassIIandIIImedicaldevices,subjecttotheirsafetyandeffectiveness.

?Clinicalevaluation–unlessotherwiseexemptfromalistissuedbytheNMPA,ClassIIandIIImedicaldevicesaresubjecttoclinicalevalu-ation.ClinicalevaluationwillbeconductedbytheNMPAaccordingtothetechnicalguid-ance.

?Clinicaltrial–iftheexistingclinicalliteratureandclinicaldataareinsufficientforevidenc-ingthesafetyandeffectivenessofamedicaldevice,aclinicaltrialshouldbeimplementedinstead.

2.3PublicAvailabilityoftheConductofaClinicalTrial

TheDrugClinicalTrialRegistrationandInforma-tionPlatform

(

)host-edbytheNMPAisapublicdatabaseprovidingdetailedinformationregardingclinicaltrialsofpharmaceuticalsforthepurposeofregistration.

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Thereisnopubliclyavailabledatabaseforclini-caltrialsofmedicaldevicesinChina.

2.4RestrictiononUsingOnlineToolstoSupportClinicalTrials

Therearenospecificrestrictionsonusingonlinetoolstosupportclinicaltrials,providedthattheuseofsuchonlinetoolsissubjecttogenerallyapplicablelawsandregulationswithrespecttopersonalinformationprotection,onlineadvertis-ing,etc.

2.5UseofDataResultingFromtheClinicalTrials

Rawdatageneratedfromclinicaltrialsmaycon-sistoftrialsubjects’personalinformation,healthdata,geneticresources,etc.

ThePersonalInformationProtectionLawofthePeople’sRepublicofChina(PIPL)cameintoeffecton1November2021andprovidesalegalframeworkfortheadministrationofhan-dlingpersonalinformation.Duringtheconductofclinicaltrials,sites,principalinvestigators,sponsor-designatedmonitorsandotherthirdpartiessuchassitemanagementorganisationsmayaccesstrialsubjects’personalinformation.However,sponsorswillnotgenerallyreceiveanyinformationthatmayidentifytrialsubjects,butwillreceiveotheranonymiseddatafromthetrial.Moreover,thesharingandtransferofpersonaldataaresubjecttootherstatutoryrequirements,suchasthereceiptofdatasubjects’consent,restrictionsoncross-borderdatatransfer,etc.

Humangeneticresourcesampleanddata(HGR)aregovernedbytheBiosecurityLaw,whichcameintoeffecton15April2021,andbythe

AdministrativeRegulationonHumanGenetic

Resources(the“HGRRegulation”).AccordingtotheHGRRegulation,HGRcollection,use,storageandtransfertoforeignpartiesmaybe

subjecttostrictstatutoryrequirements.Forthetimebeing,foreignpartiesareonlypermittedtouseChineseHGRuponfiling/approvalbytheHGRauthority.Failingtoobtainsuchapproval/filingmayresultinadministrativeliabilitiesorevencriminalliabilities.

2.6DatabasesContainingPersonalorSensitiveData

Inadditiontothestatutoryrequirementssetoutin2.5UseofDataResultingFromtheClinicalTrials,theGuidelinesforClinicalTrialDataMan-agementissuedbytheNMPAsetoutthebasicstandardsfortheresponsibility,qualificationandtrainingofpartiesresponsiblefordatamanage-ment,andrequirementsforthedesignofdatamanagementsystems,standardisationofclini-caltrialdata,qualitycontrolandtheassessmentofclinicaldata.

3.MarketingAuthorisationsforPharmaceuticalorMedicalDevices

3.1ProductClassification:

PharmaceuticalorMedicalDevices

TheDALdefinesa“drug”asasubstancethatisusedtoprevent,treatordiagnosehumandis-easesandthatisintendedtoregulatehumanphysiologicalfunctions,forwhichusageanddosagearespecifiedforindication/primarytreat-ment.Thelistoftypesofdrugsnowincludestra-ditionalChinesemedicines,chemicaldrugsandbiologicalproducts.TheCDEevaluatesdrugmarketingauthorisationapplicationssubmittedbymanufacturersordevelopmentinstitutions.

Theterm“medicaldevices”referstoinstru-ments,equipment,appliances,invitrodiag-nosticreagentsandcalibrators,materialsandothersimilarorrelatedarticles(includingcom-

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putersoftware)thatcanbeuseddirectlyorindi-rectlywithhumanbodiestoachievespecifiedpurposes(suchasdiagnosis,preventionandmonitoring)andwhoseeffectivenessisprimar-ilyachievedbyphysicalorothersimilarmeansratherthanbypharmacological,immunologicalormetabolicmeans(orundercircumstanceswheretheselattermeansserveonlyauxiliaryfunctions).TheNMPA’saffiliatedorganisa-tion,theCenterforMedicalDeviceEvaluation(CMDE),isresponsibleforthetechnicalevalua-tionofmedicaldevices.

Thefollowing