医疗器械召回管理办法试行卫生部令第8 2号.docx

医疗器械召回管理办法试行卫生部令第8 2号.docx

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医疗器械召回管理办法试行卫生部令第82号

MedicalDeviceRecallAdministrationMethod（DraftforComment）（OrderofMOHNo.82）

IssuedonMay20th,2011

OrderoftheMinistryofHealthofPeople’sRepublicofChina

No.82

TheAdministrativeMeasuresonRecallforMedicalApparatusandInstruments（ForTrialImplementation）asexaminedandapprovedbyattheministerialmeetingoftheMinistryofHealthonJune28,2010isnowpromulgatedandshallbeimplementedasofJuly1,2011.

MinisterChenZhu

May20,2011

AdministrativeMeasuresonRecallforMedicalApparatusandInstruments

（ForTrialImplementation）

Chapter1GeneralProvisions

Article1InaccordancewiththeRegulationsforthe“SupervisionandAdministrationofMedicalDevices”andthe“SpecialProvisionsoftheStateCouncilontheSafetySupervisionandAdministrationofFoodandOtherProducts”,thismethodisformulatedtostrengthenthesupervisionandadministrationofmedicaldevices,inordertosecurepeople’shealthandsafety.

Article2ThismethodappliestotherecallanditssupervisionandadministrationofallthemedicaldevicessoldinthePeople’sRepublicofChina.

Article3Themedicaldevicerecallmentionedinthismethodreferstothatthemedicaldevicemanufacturers,inaccordancewithregulatedprocedures,eliminatethehazardsoftheirmarketedproductswithpotentialhazards,bywaysofwarning,examining,repairing,relabeling,modifyingtheinstructions,updatingthesoftware,replacing,recovering,destroyingandothermethods.

Article4Thepotentialhazardsmentionedinthismethodreferstotheunreasonabledangerstohumanhealthandsafetythemedicaldeviceshaveinnormalusingconditions.

Article5Medicalinstrumentsmanufacturerswhicharethesubjecttocontrolandeliminateproductdefectsshallbeliableforthesafetyoftheirproducts.

Article6Medicaldevicemanufacturersshall,inaccordancewiththismethod,establishandperfecttheirmedicaldevicerecallsystem,collecttherelevantsafetyinformationofthemedicaldevices,searchandassessthemedicaldevicesthatmayhavepotentialhazards,andrecallthosewithsuchhazards.

Themarketersandusersofthemedicaldevicesshallassistthemanufacturersinperformingthedutyofrecalling,timelytransmitandfeedbacktherecallinformationaccordingtotherecallplans,andcontrolandrecallthosemedicaldeviceswithpotentialhazards.

Article7Whendiscoveringthatthemedicaldevicestheymarketorusehavepotentialhazards,themarketersandusersshallimmediatelyceasemarketingorusingthesedevices,informthemanufacturersorsuppliers,andreporttothedrugregulatoryauthoritiesofprovinces,autonomousregions,andmunicipalities.

Users,asthemedicalinstitutions,shallalsoreporttothehealthadministrationdepartmentattheprovincial,autonomousregionalormunicipal（directlyundertheCentralGovernment）level,wheretheusers’siteistobelocated.

Thedrugregulatorydepartmentofthepeople'sgovernmentoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernment,wherethemedicalinstrumentsoperatingenterprisesandtheirusersaretobelocated,shalltimelycirculateanoticetothedrugregulatorydepartmentofthepeople'sgovernmentoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernment,wherethemedicalinstrumentsmanufacturersaretobelocated.

Article8Thedrugregulatorydepartmentofthepeople'sgovernmentoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernment,wherethemedicalinstrumentsmanufacturerswhichshallrecalltheirproducts,andtheagentswithintheChineseterritorydesignatedbytheoverseasdrugmanufacturersimportingmedicalinstrumentsaretobelocated,shallbeliableforthesupervisionandadministrationofrecallingmedicalinstruments,andthedrugregulatorydepartmentsofotherprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernmentshallcooperateandassisttherecallofmedicalinstrumentsundertheirjurisdiction.

TheStateFoodandDrugAdministrationisresponsiblefororganizingandcoordinatingthesupervisionandadministrationofthenation’sdevicerecall.

Article9TheStateFoodandDrugAdministrationandthefoodanddrugadministrativeauthoritiesofprovinces,autonomousregions,andmunicipalitiesshallestablishinformationdisclosuresystemforthedevicerecall,anddisclosetothepublictheinformationofthedeviceswithpotentialhazardsandtheirrecallstatus.

Chapter2InvestigationandAssessmentofDefectsinMedicalDevices

Article10Themedicaldevicemanufacturersshallestablishandimprovetheirqualitycontrolsystemandadverseeventmonitoringsystem,collectandrecordqualityproblemsandinformationofadverseevents,andanalyzetheinformation.Themedicaldevicemanufacturersshallcarryoutinvestigationsonthepotentialhazardsoftheirmedicaldevices.

Themarketersandusersofthedevicesshallcooperatewiththemanufacturersordrugadministrativeauthoritiestocarryouttheinvestigations,andproviderelevantinformationandmaterialsforthispurpose.

Article11Medicalinstrumentsmanufacturersshallreporttheinformationaboutmedicalinstrumentsadverseeventstothedrugregulatorydepartmentinatimelymannerinaccordancewiththeprovisions,andthedrugregulatorydepartmentcananalyzeandinvestigatetheinformationaboutmedicalinstrumentsadverseeventsorthepossibledefects.Themedicalinstrumentsmanufacturers,operatingenterprises,andtheirusingunitsshallgiveassistancethereto.

Article12Theassessmentofthepotentialhazardsofthedevicesismainlytoexamine:

1.Ifthedevicehasmalfunctionorcausesharmswhenbeingused;

2.Ifthedevicewillcauseharmsintheexistingusingconditions,andifthereisanyscientificliterature,research,relevanttest,orverificationthatcanexplainthereasonsoftheharmsincurred;

3.Thescopeoftheareaandfeaturesofthegroupaffectedbytheharms;

4.Thedegreeofharmscausedonpeople’shealth;

5.Theprobabilityoftheharms;

6.Theshort-termandlong-termconsequencesoftheharms;

7.Otherfactorsthatmaycauseharmstohumanbody.

Article13Basedontheseriousnessofthepotentialhazardsofthemedicaldevices,thedevicerecallcanbedividedinto:

1.CategoryIRecall:

forthesedevicesmaycauseserioushazardtohealth;

2.CategoryIIRecall:

forthesedevicesmaycausetemporaryorreversiblehazardtohealth;

3.CategoryIIIRecall:

forthesedevicesnormallywillnotcausehazardtohealth,butstillneedberecalledforotherreasons.

Themedicalinstrumentsmanufacturersshallscientificallydesigntherecallplanandorganizetheimplementationofit,basedontherecallclassification,thesalesfiguresandserviceconditionsofmedicalinstruments.

Chapter3VoluntaryRecall

Article14Themedicaldevicemanufacturersshallanalyzetheinformationtheycollected,andcarryoutinvestigationsandassessmentonthedeviceswithpotentialhazardsaccordingtotherequirementsunderArticle10and11underthismethod.Oncediscoveringthepotentialhazardsofcertaindevices,theyshalldeterminetorecallthesedevices.

Whenforeignmanufacturersofimporteddevicesrecalltheirproductsinforeigncountries,theyshalltimelyreporttotheStateFoodandDrugAdministration;iftherecallisdonewithinChina,theagentsdesignatedbytheforeignmanufacturersinChinashallberesponsiblefortheperformanceoftherecallaccordingtothismethod.

Article15Whenmakingthedecisionofrecallingthemedicaldevices,CategoryIRecallshallbedownwithin1day,CategoryIIwithin3days,CategoryIIIwithin7days,andtherecallshallbeinformedoftothemarketersandusersofthedevices.

Therecallnoticeshallcomprisethefollowingcontent:

1.Thedetailedinformationoftherecalledmedicaldevices,includingname,lotnumber,andotherbasicinformation;

2.Reasonsofrecall;

3.Ifimmediatelyceasingmarketingandusingthisdevice,themarketersshallforwardtherecallnoticetootherorganizationswheretherecalledproductsarelocated.

5.Suggestionsonhowtotreattherecalledproducts.

Article16Afterinitiatingtherecallprocedures,themanufacturersshallreporttothedrugregulatoryauthoritiesofprovinces,autonomousregions,andmunicipalitiesinwrittenformandfillinthe“MedicalDeviceRecallReportForm”（Appendix1）,within5days.Atthesametime,theyshallalsosubmittheinvestigationandassessmentreportandrecallplantothedrugadministrativeauthoritiesfortherecord.

WhenperformingCategoryIRecall,themanufacturersshallreporttotheadministrativeauthoritiesofprovinces,autonomousregions,andmunicipalitiesintheirjurisdictionsfortherecord,whichshalltimelyreporttotheSFDA.

Article17Theinvestigationandassessmentreportshallcomprisethefollowingcontent:

1.Thedetailedinformationoftherecalledmedicaldevices,includingname,lotnumber,andotherbasicinformation;

2.Reasonsofrecall;

3.Resultsoftheinvestigationandassessment;

4.Categoryoftherecall.

Therecallplanshallcomprisethefollowingcontent:

1.Theproductionandmarketinginformationofthedevicesandthequantityofrecall;

2.Thedetailedcontentoftherecallmeasures,includingtheorganization,scope,andtimelimitoftherecall;

3.Thechannelandscopeoftherecallinformationdisclosure;

4.Theexpectedeffectoftherecall;

5.Treatmentmeasuresforthedevicesafterrecall.

Article18Thedrugadministrativeauthoritiesmay,accordingtotheactualsituation,organizeexpertstoevaluatetherecallplansubmittedbythemedicaldevicemanufacturers.Ifthemeasures