SFDA order No16 Methods of registration and administration for medical apparatus and instruments.docx
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SFDA order No16 Methods of registration and administration for medical apparatus and instruments.docx
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SFDAorderNo16Methodsofregistrationandadministrationformedicalapparatusandinstruments
ACTSOFTHESTATEBUREAUOFFOODANDDRUGSUPERVISIONANDADIMINSTRATION
No.16
DirectorZhengXiao-yu
August9th,2004
MethodsofregistrationandadministrationformedicalapparatusandinstrumentsChapterIGeneralprovisions
Article1Thismethodwasstipulatedbasedon
Article2MedicalapparatusandinstrumentstobesoldandusedwithinthebordersofthePeople’sRepublicofChinashallapplyforregistration,accordingtothestipulationslaiddowninthismethod,thosemedicalapparatusandinstrumentsthatarenotobtainedpermissionforregistrationareprohibitedfrombeingsoldandused.
Article3Registrationformedicalapparatusandinstrumentsreferstotheprocessofevaluatingthesafetyandeffectivenessofthemedicalapparatusandinstrumentsintendedtobesoldandusedsystematicallyinthelightofthelegalprocedure,astodeterminewhethertheycanbesoldandused.
Article4Chinainstitutesthemedicalapparatusandinstrumentsaccordingtotheclassification.
MedicalapparatusandinstrumentsofClass1withinourbordersshallbeexaminedbytheFoodandDrugSupervisionandAdministrationorganatthelevelofmunicipality,andissuedtheregistrationcertificateofmedicalapparatusandinstrumentsafterapproval.
MedicalapparatusandinstrumentsofClass2withinourbordersshallbeexaminedbytheFoodandDrugSupervisionandAdministrationorganatthelevelofprovince,autonomousregionandmunicipalitydirectlyundertheCenterGovernmentandthenissuedtheregistrationcertificateofmedicalapparatusandinstruments.
MedicalapparatusandinstrumentsofClass3withinourbordersshallbeexaminedbytheStateBureauofFoodandDrugSupervisionandAdministrationandissuedtheregistrationcertificateofmedicalapparatusandinstrumentsafterapproval.
MedicalapparatusandinstrumentsabroadshallbeexaminedbytheStateBureauofFoodandDrugSupervisionandAdministrationandissuedtheregistrationcertificateofmedicalapparatusandinstrumentsafterapproval.
RegistrationforthemedicalapparatusandinstrumentsfromTaiwan,HongkongandMacaoshallrefertothatforthemedicalapparatusandinstrumentsabroadbesidesthespecificstipulationsofthismethod.
Thetermofvalidityoftheregistrationcertificateforthemedicalapparatusandinstrumentsshallbe4years.
Article5RegistrationcertificateofthemedicalapparatusandinstrumentsshallbecentralizedprintedbytheStateBureauofFoodandDrugSupervisionandAdministrationandthecorrespondingcontentsshallefilledinbythefoodanddrugsupervisionandadministrationdepartmentsinchargeofexaminationandapprovalforregistration.
Theregistrationnumberisarrangedasfollows:
x(x)1(F)SFDA(x2)xxxx3x4xx5xxxx6,where:
x1Shortformofthelocationoftheregistrationandexaminationdepartment:
FormedicalapparatusandinstrumentsofClass3withinourborders,medicalapparatusandinstrumentsabroadandthosefromTaiwan,HongkongandMacao:
itwillbe(C);
FormedicalapparatusandinstrumentsofClass2withinourborders:
itwillbetheshortformoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernmentwherethedepartmentsforregistrationandexaminationare;
FormedicalapparatusandinstrumentsofClass1withinourborders:
itwillbetheshortformoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernmentwherethedepartmentsforregistrationandexaminationareplustheshortformoftheadministrativeregionatthemunicipalitylevelinthecommunity,i.e.xx1(Itwillbeonlytheshortformoftheprovince,autonomousregionorthemunicipalitydirectlyundertheCentralGovernmentifthereisnocorrespondingadministrativeregionatthemunicipalitylevel);
x2istheregistrationform(Approval,importandallowance)
“Approval”appliestomedicalapparatusandinstrumentswithinourborders;
“Import”appliestomedicalapparatusandinstrumentsabroad;
“Allowance”appliestomedicalapparatusandinstrumentsfromTaiwan,HongkongandMacao;
xxxx3istheyearforapproval;
x4isthecategoryofproductionadministration;
xx5isthenumberofproductionvariety;
xxxx6istheserialnumberofregistration.
Theregistrationcertificateisaccompaniedwiththe
Article6Wheremanufacturersapplyformedicalapparatusandinstrumentsregistrationshallundertakethecorrespondinglegalobligationsandkeeptheregistrationcertificateofmedicalapparatusandinstrumentsafterapproval.
Whoeverthatconducttheapplicationforregistrationofmedicalapparatusandinstrumentsshallbeentrustedbythemanufacturers,andshallpossessthecorrespondingprofessionalknowledge,andbefamiliarwiththelaws,regulations,rulesandtechnicalrequirementsforregistrationofmedicalapparatusandinstruments.
Manufacturersabroad,applyingforregistrationofmedicalapparatusandinstrumentsabroadshallappointanorgantobeitsagentinChina,thatwillundertakethecorrespondinglegalobligations;Meanwhile,themanufacturersshallentrustaqualifiedlegalorganinChinaorentrustitsorganinChinatoundertaketheaftersaleserviceformedicalapparatusandinstruments.
Article7Thereshallbeapplicableproductstandardsforthemedicalapparatusandinstrumentsappliedforregistration,eitheradoptingthenationalstandardsorthetradestandards,orstipulatingthestandardsfortheregisteredproducts,which,however,shallnotbelowerthanthenationalstandardorthetradestandard.
ThestandardforregisteredproductsshallbestipulatedinthelightoftheadministrationrequirementsformedicalapparatusandinstrumentstandardslaiddownbytheStateBureauofFoodandDragSupervisionandAdministration.
Article8ManufacturersapplyingforregisteringmedicalapparatusandinstrumentofClass2andClass3shallmeettherequirementsforproductionconditionsorfortherelatedqualitysystemlaiddownbytheStateBureauofFoodandDragSupervisionandAdministration.
ChapterIIRegistrationtestformedicalapparatusandinstrument
Article9MedicalapparatusandinstrumentofClass2andClass3shallbesubjectedtoregistrationtestcarriedoutbytheStateBureauofFoodandDragSupervisionandAdministrationandthetestorgansapprovedbytheStateGeneralofAdministrationofQualitySupervision,InspectionandQuarantineofthePeople’sRepublicofChina.Medicalapparatusandinstrumentsshallbeusedinclinictestsorforregistrationapplicationonlyafterprovingthattheyareinaccordwiththeapplicableproductstandards.
ListofthetestorgansapprovedbytheStateBureauofFoodandDragSupervisionandAdministrationandtheStateGeneralofAdministrationofQualitySupervision,InspectionandQuarantineofthePeople’sRepublicofChina(hereinafterreferredtoasthetestorganofmedicalapparatusandinstrument)willbenotifiedlater.
Article10Thetestorgansshallcarryoutregistrationandtestforthedeclaredproducts,basedontheapplicableproductstandardsdeclaredbythemanufacturer(includingtheapplicablenationalstandards,tradestandardsorstandardsforregisteredproductsstipulatedbythemanufacturer)withinthetestrangesapprovedbytheStateBureauofFoodandDragSupervisionandAdministrationandtheStateGeneralofAdministrationofQualitySupervision,andissuethetestreport.
Medicalapparatusandinstrumentbeyondthetestrangesauthorizedbythetestorgansshallbetestedbythosetestunitscapableofundertakingthetestsappointedbythecorrespondingregistrationandtestdepartments.
Article11Productstestedinthesameregistrationunitshallbethetypicalproductscapableofrepresentingthesafetyandeffectivenessofotherproductsinthesameregistrationunit.
Article12Thebiologicalcompatibilitytestforbiologyevaluationoftheproductsmaybeomittedfortheproducts,ofthesamecategory,madebythesamemanufacturerandwiththesamerawmaterials,duringre-registrationiftheproductiontechnologyandthedesiredusedkeepunchanged.
Thebiologicalcompatibilitytestforbiologyevaluationoftheproductsmaybeomittedfortheproductsofthesamecategory,madebythesamemanufacturerandwiththerawmaterialpassingthroughthebiologyevaluation,duringapplicationforregistrationiftheproductiontechnologiesandthedesiredusekeepunchangedorthereisnonewpotentialbiologyrisk.
Article13ProductsapplyingforregisteringmedicalapparatusandinstrumentofClass2andClass3andconcurrentlymeetingthefollowingrequirements,shallbeexemptedfromtheregistrationtest:
1)Thebasicprinciples,mainfunctions,structure,material
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