监督英文

Regulations

RegulationsfortheSupervisionandAdministrationof

MedicalDevices

RegulationsfortheSupervisionandAdministrationofMedicalDevices

ChapterIGeneralProvisions

Article1TheRegulationsareherebyformulatedwithaviewtostrengtheningthe

supervisionandadministrationofmedicaldevices，ensuringtheirsafetyand

effectivenessandprotectinghumanhealthandlifesafety。

Article2Allunitsorindividualngagedintherearchanddevelopment，production，

distribution，u,supervisionandadministrationofmedicaldeviceswithintheterritory

ofthePeoplesRepublicofChinashallcomplywiththeRegulation.

Article3”Medicaldevices”asdefinedbytheregulationsrefersto：anyinstrument，

apparatus，appliance,material,orotherarticlewhetherudaloneorincombination,

includingthesoftwarenecessaryforitsproperapplication。Itdoesnotachieveits

principalactioninoronthehumanbodybymeansofpharmacology，immunologyor

metabolism,butwhichmaybeassistedinitsfunctionbysuchmeans;theuofwhichis

toachievethefollowingintendedobjectives:

sis，prevention，monitoring，treatmentoralleviationofdia;

sis，monitoring,treatment，alleviationoforcompensationforaninjuryor

handicapconditions；

3。Investigation,replacementormodificationforanatomyoraphysiologicalprocess;

4。Controlofconception.

Article4ThedrugregulatoryauthorityundertheStateCouncilisresponsiblefor

gadministrationof

thelocalgovernmentatcountylevelandaboveisresponsibleforsupervisionand

administrationofmedicaldevicesineachadministrativeregion。Thedrugregulatory

authorityundertheStateCouncilshallcoordinatewithotherdepartmentsunderthe

StateCouncil，responsibleforcomprehensiveeconomicadministration,inthe

implementationofpoliciesforthemedicaldeviceindustry。

Article5TheStateshallclassifymedicaldevicesandadministerthembadonthis

classification

ClassIMedicalDevicesarethoforwhichsafetyandeffectivenesscanbeensured

throughroutineadministration；

ClassIIMedicalDevicesarethoforwhichfurthercontrolisrequiredtoensuretheir

safetyandeffectiveness

ClassIIIMedicalDevicesarethowhichareimplantedintothehumanbody,orudfor

lifesupportorsustenance,orpopotentialrisktothehumanbodyandthusmustbe

strictlycontrolledinrespecttosafetyandeffectiveness。

Theclassificationcatalogueformedicaldevicesshallbestipulated，adjustedand

promulgatedbythedrugregulatoryauthorityundertheStateCouncil,inaccordancewith

classificationprinciplesafterconsultingwithhealthauthorityundertheStateCouncil。

Article6Medicaldevicesproducedandudforthepurpoofprovidingconcrete

ailed

productlistshallbeformulatedandpromulgatedbythedrugregulatoryauthorityunder

theStateCouncil，jointlywiththemeteringauthority.

ChapterIITheAdministrationofMedicalDevices

Article7TheStateencouragestherearchanddevelopmentofnewmedical

devices。”Newmedicaldevices"refertothekindofbrandnewproductvarietieswhich

havenotbeenavailableinthedomesticmarket,orforwhichthesafety,effectiveness

andproductmechanismhavenotbeenrecognizeddomestically。

TheclinicaltrialsofnewmedicaldevicesofClassIIandClassIIIcanbeconductedonly

afterclinicaltrialapprovalbytherelevantauthorityinaccordancewiththerulesofthe

drugregulatoryauthorityunderStateCouncil。

Newmedicaldevicesthathavecompletedclinicaltrialsandpasdexpertvaluation

andrevieworganizedbythedrugregulatoryauthorityunderStateCouncil，shallreceive

anewproductcertificateafterbeingapprovedbythesameorganization。

Article8TheStateshallimplementaproductregistrationsystemforthemanufacturing

ofmedicaldevices.

ClassImedicaldevicesshallbeinspected,approvedandgrantedwitharegistration

certificatebythedrugregulatoryauthorityofthegovernmentofthemunicipalities

consistingofdistricts。

ClassIImedicaldevicesshallbeinspected，approvedandgrantedwithregistration

certificatesbythedrugregulatoryauthoritiesofprovinces，autonomousregionsand

municipalitiesdirectlyunderthecentralgovernment。

ClassIIImedicaldevicesshallbeinspected,approvedandgrantedwithregistration

certificatesbythedrugregulatoryauthoritydirectlyundertheStateCouncil。

ClinicalevaluationmustbeconductedforClassIIandClassIIImedicaldevicesbefore

theyareputintoproduction。

Article9Thedrugregulatoryauthoritiesofprovinces,autonomousregionsand

municipalitiesdirectlyunderthecentralgovernmentareresponsiblefortheinspection

andapprovaloftheclinicaltrialorverificationofclassIImedicaldevicesintheirown

gregulatoryauthorityundertheStateCouncilis

responsiblefortheinspectionandapprovalofclinicaltrialorverificationofclassIII

medicaldevices.

Clinicaltrialorverificationshallbeconductedinthemedicalinstitutionsdesignatedby

thedrugregulatoryauthoritiesofthegovernmentatprovinciallevelandabove。The

medicalinstitutionsshallconducttheclinicaltrialorverification，inaccordancewiththe

relatedprovisionsofthedrugregulatoryauthorityundertheStateCouncil。

Thequalificationofmedicalinstitutionngagedintheclinicaltrialorverificationshallbe

certifiedbythedrugregulatoryauthority,jointlywiththehealthauthorityunderthe

StateCouncil。

Article10Medicalinstitutionsmaydevelopmedicaldevicestorvetheirownclinical

needs，anduthemwithintheirowninstitutionundertheguidanceoflicendmedical

practitioners.

ClassIImedicaldevicesdevelopedbymedicalinstitutionsshallbeinspectedand

approvedbythedrugregulatoryauthorityofthegovernmentatprovincialleveland

above。ClassIIImedicaldevicesdevelopedbymedicalinstitutionsshallbeinspected

andapprovedbythedrugregulatoryauthorityundertheStateCouncil。

Article11WhenimportingmedicaldevicesintoChinaforthefirsttime,theagentofthe

importeddevice,shouldsubmittheinstructionforu，qualitystandards，testing

methods,otherrelevantinformation,productsamples，andmarketingauthorization

certificatesissuedbythemanufacturingcountries（regions）,forinspectionand

approvalbythedrugregulatoryauthorityundertheStateCouncil，andreceivean

importproductregistrationcertificatebeforeapplyingforcustomsformalities。

Article12Whenapplyingforregistrationofmedicaldevices，technicalstandards,

testingreportandotherrelevantinformationshallbesubmittedaccordingtoprovisions

ofthedrugregulatoryauthorityundertheStateCouncil.

Thedrugregulatoryauthorityofthegovernmentofthemunicipalityconsistingofdistricts

shalldecidewithin30workingdaysiftheproductcanberegistered,countingfromthe

dateofacceptanceoftheapplication。Forthonotapprovedforregistration,awritten

explanationshallbegiventotheapplicant。

Thedrugregulatoryauthorityofgovernmentsofprovinces，autonomousregionsand

municipalitiesdirectlyundercentralgovernmentshalldecidewithin60workingdaysif

theproductcanberegistered,countingfromthedateofacceptanceoftheapplication。

Forthonotapprovedforregistration,awrittenexplanationshallbegiventothe

applicant。

ThedrugregulatoryauthorityundertheStateCouncilshalldecidewithin90workingdays

iftheproductcanberegistered，countingfromthedateofacceptanceoftheapplication.

Forthonotapprovedforregistration,awrittenexplanationshallbegiventothe

applicant.

Article13Incaanysituationreflectedinthecontentoftheregistrationcertificateis

changed，theholderofthecertificateshallapplyforanamendmentofthecertificate

accordingly,orforre—registrationwithin30workingdaysfromthechange。

Article14Thetermofvalidityfortheregistrationcertificateofmedicaldevicesisfour

years。Theholderofthecertificateshallapplyforre—registrationwithinsixmonths

beforethecertificateexpires。

Whenthemanufacturingofamedicaldeviceisstoppedcontinuouslyformorethan2

years，itsregistrationcertificateisautomaticallyinvalidated。

Article15Medicaldevicesmanufacturedshallmeetthenationalstandard，or

professionalstandardswhentherearenorelevantnationalstandardsavailable.

Nationalstandardsofmedicaldevicesshallbeformulatedjointlybythestandardization

sional

standardsofmedicaldevicesshallbeformulatedbythedrugregulatoryauthorityunder

theStateCouncil.

Article16Theinstructionforu,labelandpackageofmedicaldevicesshallcomply

withrelevantstandardsorprovisionsinChina.

Article17Theregistrationnumberofamedicaldeviceshallbemarkedontheproduct

itlfandtheexternalpackageaccordingtotheprovisionsofthedrugregulatory

authorityundertheStateCouncil.

Article18TheStateimplementsasystemofre—evaluationandobsolescencefor

medicaldevices，thedetailsofwhichshallbeformulatedbydrugregulatoryauthority

undertheStateCouncilafterconsultingwithotherrelatedauthoritiesundertheState

Council。

ChapterIIIAdministrationofProduction，DistributionandU

ofMedicalDevices

Article19Enterprismanufacturingmedicaldevicesshallmeetthefollowing

conditions:

1。Posssprofessionaltechnicalpersonnelrequiredforthemanufactureofitsmedical

devices；

2。Posssfacilityandenvironmentrequiredforthemanufactureofitsmedical

devices；

3。Possquipmentrequiredforthemanufactureofitsmedicaldevices；

4。Posssanestablishmentorpersonnelandequipmentforqualitytestingrequiredfor

themanufactureofitsmedicaldevices。

Article20EstablishmentofmanufacturingofclassImedicaldevices，requiresthatthe

enterprifilearecordwiththedrugregulatoryauthorityofprovinces，autonomous

regionsormunicipalitiesdirectlyunderthecentralgovernment。

EstablishingmanufacturingofclassIIand/orclassIIImedicaldevices,requires

inspectionandapprovalbythedrugregulatoryauthoritiesoftheprovinces，autonomous

regionsandmunicipalitiesdirectlyunderthecentralgovernment,whowillthenissuea

ustrialandcommercialauthority

shallnotissueabusinesslicentoenterpriswhichhavenotreceivedaMedicalDevice

ManufacturingEnterpriLicen.

ThetermofvalidityoftheMedicalDeviceManufacturingEnterpriLicenis5years。

Uponexpiration，re-inspectionandlicenrenewalshallbeconducted。Implementation

detailsshallbeformulatedbythedrugregulatoryauthorityundertheStateCouncil。

Article21Medicaldevicemanufacturingenterprisshallnotstartmanufacturing

productsbeforeobtainingthemanufacturingenterprilicen.

Article22TheStateimplementsamandatorysafetycertificationsystemforcertainclass

ficproductlistshallbeestablishedbythedrugregulatory

authorityundertheStateCouncil,jointlywiththequalityandtechnologysupervision

authority.

Article23Enterprisdistributingmedicaldevicesshallmeetthefollowingconditions:

sappropriatefacility(s)andenvironmentforthekindofmedicaldevicestobe

distributed；

2。Posssappropriatequalityinspectionpersonnelforthekindofmedicaldevicestobe

distributed；

sadequateabilityfortechnicaltraining,maintenanceandafter-salesrvices

forthekindsofmedicaldevicestobedistributed;

Article24EstablishingofdistributionofclassIIand/orclassIIImedicaldevices,

requiresthattheenterprifilearecordwiththedrugregulatoryauthorityofprovinces，

autonomousregionsormunicipalitiesdirectlyunderthecentralgovernment.

EstablishinganenterpridistributingclassIIand/orclassIIImedicaldevices，requires

inspectionandapprovalbythedrugregulatoryauthoritiesoftheprovinces，autonomous

regionsandmunicipalitiesdirectlyunderthecentralgovernment,whowillthenissuea

MedicalDeviceDistributingEnterpriLicen。Theindustrialandcommercialauthority

shallnotissueabusinesslicentoenterpriswhichhavenotreceivedaMedicalDevice

DistributingEnterpriLicen.

Thetermof

expiration，re-inspectionandlicenrenewalshallbeconducted。Implementation

detailsshallbeformulatedbythedrugregulatoryauthorityundertheStateCouncil.

Article25Thedrugregulatoryauthorityofgovernmentsofprovinces，autonomous

regionsandmunicipalitiesdirectlyundercentralgovernmentshalldecidewithin30

workingdayswhetherthelicensformanufacturingordistributingenterprisof

medicaldevicescanbeissued,countingfromthedateofacceptanceoftheapplication。

Whenalicenisnotissued,awrittenexplanationshallbegiventotheapplicant.

Article26Distributionenterprisandmedicalinstitutionsshallpurchaqualified

medicaldevicesfromenterprishavingaMedicalDeviceManufacturingEnterpri

LicenorMedicalDeviceDistributionEnterpriLicen,andshallverifythecertificates

ofqualifiedproducts。

Distributionenterprisshallnotdistributemedicaldeviceswithoutregistration

certificatesorcertificatesforqualifiedproducts,ormedicaldeviceswhicharebeyond

theirexpirydates,ofcompromideffectiveness,orobsolete.

Medicalinstitutionsshallnotumedicaldeviceswithoutregistration,orcertificatefor

qualifiedproducts,ormedicaldeviceswhicharebeyondtheirexpirydates,of

compromideffectiveness,orobsolete。

Article27Medicalinstitutionsshallnotre—umedicaldeviceslabeledforsingleu,

shalldestroythemafteruandestablisharecord，accordingtorelevantprovisionsof

thecountry。

Article28TheStateshallestablishaqualityincidentreportingsystemandawarning

systemofmedicaldevices。Implementationdetailsshallbestipulatedbythedrug

regulatoryauthorityundertheStateCouncil，inconjunctionwiththehealthauthority

andfamilyplanningauthorityundertheStateCouncil.

ChapterIVSupervisionofMedicalDevices

Article29Thedrugregulatoryauthoritiesofgovernmentsatcountylevelandabove

shallappointmedicaldevicemonitorswithintheirorganization,whoareresponsiblefor

thesupervisionandinspectionofmedicaldevicemanufacturingenterpris，distribution

enter

necessary,monitorsmaytakeproductsamplesandaskforrelevantmaterialsaccording

totheprovisionspromulgatedbythedrugregulatoryauthorityundertheStateCouncil。

Institutionsandindividualsconcernedshallnotdeclinecooperationorbedeceitfulinthe

monitoringprocess。Themonitorsshallberesponsibletokeepcollectedsamplesand

materialsconfidential.

Article30TheStateimplementsanaccreditationsystemforthequalificationofthe

stinginstitutionsaccreditedbythedrug

regulatoryauthorityinconjunctionwiththequalityandtechnicalsupervisionauthority

undertheStateCouncilmayconductmedicaldevicetest.

Medicaldevicetestinginstitutionsandtheirstaffmembersshallkeepstrictlyconfidential

alltechnicalinformationprovidedbyenterpriswhoproductsarebeingtested，and

shallnotconductorbeinvolvedinrearchanddevelopment,manufacture,distribution

andtechnicalconsultationrelatedtothedevicestested。

Article31Forproductshavingcaudorwhichmaypotentiallycauqualityincidents,

thedrugregulatoryauthorityofthegovernmentsatcountylevelandaboveshallhave

therighttocheck，alupanddetainthemtogetherwithmaterialsrelated.

Article32Thedrugregulatoryauthorityofthegovernmentsatprovincialleveland

aboveshallrevoketheregistrationcertificatesofmedicaldevicesofwhichsafetyand

ldeviceswhoregistrationcertificateshave

beenrevokedshallnotbemanufactured，lreadyproduced

orimportedshallbedealtwithbythedrugregulatoryauthorityofgovernmentatcounty

levelandabove.

Article33Thedrugregulatoryauthoritiesofthegovernmentofthemunicipality

consistingofdistrictsandabove,whichperformproductregistrationsinviolationofthe

regulations,shallbeorderedbythedrugregulatoryauthorityunderthestatecouncilto

correcttheviolationswithinadefinedperiod。Forthonotcorrectedwithintheperiod,

theproductregistrationcertificatesmayberevokedandtheeventsmaybemade

public。

Article34Advertimentsofmedicaldevicesshallbereviewedandapprovedbythe

drugregulatoryauthorityofgovernmentsatprovinciallevelandabove，andshallnotbe

published，broadcasted,circulatedorpostedbeforetheapproval。

Thecontentsoftheadvertimentsshallbebadontheinstructionforuapprovedby

thedrugregulatoryauthorityundertheStateCouncilorthedrugregulatoryauthorityof

thegovernmentsofprovinces，autonomousregionsandmunicipalitiesdirectlyunderthe

CentralGovernment.

ChapterVPenalties

Article35Incasofmanufacturingmedicaldeviceswithoutproductregistration

certificates，inviolationofprovisionsoftheRegulations，thedrugregulatory

authorityofgovernmentsatcountylevelandaboveshallissueanordertostopthe

production，confiscatealloftheillegallymanufacturedproductsandrelatedillegal

onally,incatheillegalincomexceedRMB10thousandyuan,afineof3

to5timesthetotalsumoftheillegalincomeshallbeimpod；incathereareno

illegalincomesortheillegalincomesdonotexceedRMB10thousandyuan,afineof

RMB10thousandyuantoRMB30thousandyuanshallbeimpod;inriouscas,the

drugregulatoryauthoritiesofthegovernmentsattheprovinces，autonomousregions

andmunicipalitiesdirectlyundertheCentralGovernmentshallrevoketheMedicalDevice

ManufacturingEnterpriLicen;andincacrimesarecommitted,criminalliability

shallbeinvestigatedandhandledaccordingtothelaw.

Article36IncasofmanufacturingclassIIandclassIIImedicaldeviceswithouta

MedicalDeviceManufacturingEnterpriLicen，inviolationoftheregulations,the

drugregulatoryauthorityofgovernmentsatcountylevelandaboveshallissueanorder

tostoptheproduction,confiscatealloftheillegallymanufacturedproductsandtheir

onally，incatheillegalincomexceedRMB10thousandyuan，

afineof3to5timesofthetotalsumoftheillegalincomesshallbeimpod；inca

therearenoillegalincomesortheillegalincomesdonotexceedRMB10thousandyuan,a

fineofRMB10thousandyuantoRMB30thousandyuanshallbeimpod;andinca

crimesarecommitted，criminalliabilityshallbeinvestigatedandhandledaccordingto

thelaw.

Article37Incasofmanufacturingmedicaldevicesnotinconformitywithnational

standardsorprofessionalstandardsformedicaldevices，inviolationofprovisionsof

theRegulations,thedrugregulatoryauthorityofgovernmentsatcountyleveland

aboveshallissueanwarning，followedwithanordertostoptheproduction，confiscate

alloftheillegallymanufacturedproductsandtheirillegalincomes。Additionally，inca

theillegalincomexceedRMB5thousandyuan,afineof2to5timesofthetotalsum

oftheillegalincomesshallbeimpod;incatherearenoillegalincomesortheillegal

incomesdonotexceedRMB5thousandyuan，afineofRMB5thousandto20thousand

yuanshallbeimpod；inriouscas，theproductregistrationcertificatesshallbe

revokedbytheauthoritiesoriginallyissuedthecertificates；andincacrimesare

committed，criminalliabilityshallbeinvestigatedandhandledaccordingtothelaw。

Article38IncasofDistributionofclassIIandclassIIImedicaldeviceswithouta

MedicalDeviceDistributingEnterpriLicen,whichviolatesprovisionsofthe

Regulations,thedrugregulatoryauthorityofgovernmentsatcountylevelandabove

shallissueanordertostoptheproduction,confiscatealloftheillegallymanufactured

productsandtheirillegalincomes。Additionally，incatheillegalincomexceedRMB

5thousandyuan,afineof2to5timesofthetotalsumoftheillegalincomesshallbe

impod;incatherearenoillegalincomesortheillegalincomesdonotexceedRMB5

thousandyuan，afineofRMB5thousandyuantoRMB20thousandyuanshallbe

impod;andincacrimesarecommitted,criminalliabilityshallbeinvestigatedand

handledaccordingtothelaw.

Article39Incasofdistributingmedicaldeviceswithoutregistrationcertificatesor

certificateforqualifiedproducts，ormedicaldeviceswhicharebeyondtheirexpirydates,

ofcompromideffectiveness,orobsolete,orpurchasingmedicaldevicesfrom

enterpriswithoutMedicalDeviceManufacturingEnterpriLicenorMedicalDevice

DistributingEnterpriLicen,whichviolatesprovisionsoftheRegulations,thedrug

regulatoryauthorityofgovernmentsatcountylevelandaboveshallissueanorderto

stopthedistribution，confiscatealloftheillegallydistributedproductsandtheirillegal

incomes。Additionally,incatheillegalincomexceedRMB5thousandyuan,afineof

2to5timesofthetotalsumoftheillegalincomesshallbeimpod；incathereare

noillegalincomesortheillegalincomesdonotexceedRMB5thousandyuan，afineof

RMB5thousandto20thousandyuanshallbeimpod；inriouscas，theMedical

DeviceDistributingEnterpriLicenshallberevokedbytheauthoritieswhichoriginally

issuedthelicen;andincacrimesarecommitted,criminalliabilityshallbe

investigatedandhandledaccordingtothelaw.

Article40Incaswherefalcertificates，documents,materials,orproductsamples

aresubmittedinregistrationapplications，orobtainingmedicaldeviceregistration

certificatesareobtainedusingotherdeceitfulmeans，whichviolateprovisionsofthe

Regulations,theproductregistrationcertificatesshallberevokedbytheauthoritieswhich

originallyissuedthecertificates,andwithinaperiodoftwoyears,otherproduct

registrationapplicationsoftheviolatingenterprishallnotbeaccepted。Additionally,a

fineofRMB10thousandto30thousandyuanshallbeimpod;forenterprisalready

startedmanufacturing，alloftheillegallymanufacturedproductsandtheirillegal

incomesshallbeconfiscated;incatheillegalincomexceedRMB10thousandyuan，

afineof3to5timesofthetotalsumoftheillegalincomesshallbeimpod;inca

therearenoillegalincomesortheillegalincomesdonotexceedRMB10thousandyuan，

afineofRMB10thousandto30thousandyuanshallbeimpod;andincacrimesare

committed，criminalliabilityshallbeinvestigatedandhandledaccordingtothelaw。

Article41ViolationofArticle34oftheRegulationsconcerningprovisionsfor

advertimentofmedicaldevicesshallbedealtwithbytheindustrialandcommercial

authorityaccordingtorelevantlawsandregulationsofthecountry.

Article42IncasofMedicalinstitutionsusingmedicaldeviceswithoutregistration

certificatesorcertificateforqualifiedproducts，ormedicaldeviceswhicharebeyond

theirexpirydates,ofcompromideffectiveness,orobsolete,orpurchasingmedical

devicesfromenterpriswithoutMedicalDeviceManufacturingEnterpriLicenor

MedicalDeviceDistributingEnterpriLicen，whichviolateprovisionsofthe

Regulations，thedrugregulatoryauthorityofgovernmentsatcountylevelandabove

shallissueanorderforcorrection，launchawarning，andconfiscatealloftheillegally

udproductsandillegalincomes。Additionally，incatheillegalincomexceedRMB

5thousandyuan，afineof2to5timesofthetotalsumoftheillegalincomesshallbe

impod；incatherearenoillegalincomesortheillegalincomesdonotexceedRMB5

thousandyuan，afineofRMB5thousandto20thousandyuanshallbeimpod,and

person(s)inchargeandotherdirectlyresponsiblepersonnelshallreceivedisciplinary

punishment；andincacrimesarecommitted，criminalliabilityshallbeinvestigated

andhandledaccordingtothelaw.

Article43Incasofmedicalinstitutionsre-usingdevicesforsingleu,ornot

destroyingdeviceswhichshouldbedestroyed,whichviolatesprovisionsofthe

Regulations，thedrugregulatoryauthorityofgovernmentsatcountylevelandabove

shallissueanorderforcorrectionandlaunchawarning，andmayimpoafineofRMB

5thousandto30thousandyuan;inriouscas,themedicalinstitutionsmaybe

appliedwithafineofRMB30thousandto50thousandyuan，andperson（s）incharge

andotherdirectlyresponsiblepersonnelbeappliedwithdisciplinarypunishment;andin

cacrimesarecommitted，criminalliabilitiesshallbeinvestigatedandhandled

accordingtothelaw.

Article44Incasinwhichmedicalinstitutionsundertakeclinicaltrialsorclinical

verificationsofmedicaldevicesandprovidefalreports,whichviolatesprovisionsof

theRegulations，thedrugregulatoryauthorityofgovernmentsatprovincialleveland

aboveshallissueanorderforcorrectionandlaunchawarning，andmayimpoafine

ofRMB10thousandto30thousandyuan；inriouscas，thequalificationforclinical

trialorclinicalverificationofmedicaldevicesshallbeterminated,person(s)inchargeand

otherdirectlyresponsiblepersonnelshallreceivedisciplinarypunishment；andinca

crimesarecommitted,criminalliabilityshallbeinvestigatedandhandledaccordingtothe

law.

Article45Forcasinwhichtestinginstitutionsandtheirpersonnelarefoundtobe

conductingorinvolvedinrearchanddevelopment,manufacturing,distributionand

technicalconsultationofmedicaldeviceswhicharerelatedtothetesting,orestablishing

faltestingreports,whichviolatesprovisionsoftheRegulations,thedrugregulatory

authorityofgovernmentsatprovinciallevelandaboveshallissueanorderforcorrection

andlaunchawarning，andmayimpoafineofRMB10thousandto30thousand

yuan；inriouscas，thequalificationfortestingshallbeterminatedbythedrug

regulatoryauthorityundertheStateCouncil，person（s）inchargeandotherdirectly

responsiblepersonnelshallbereceivedisciplinarypunishment；andincacrimesare

committed，criminalliabilityshallbeinvestigatedandhandledaccordingtolaw.

Article46Incaswherepersonnelengagedinsupervisionandadministrationof

medicaldevicesabutheirpower，pursuepersonalbenefitsbydeceiving，or

neglectingtheirduties，inviolationofprovisionsoftheRegulations，totheextentto

whichcrimesarecommitted，criminalliabilitiesshallbeinvestigatedandhandled

accordingtothelaw。Forthonotcommittingcrimes，disciplinarypunishmentshallbe

appliedaccordingtotherelevantregulations.

ChapterVISupplementaryProvisions

Article47Provisionsgoverningnon-profitablecontraceptivedevicesshallbeformulated

paratelybythedrugregulatoryauthorityinconjunctionwithotherrelevantauthorities

undertheStateCouncil。

Article48TheRegulationsshallcomeintoforcefromApril1，2000。