SFDA order No16 Methods of registration and administration for medical apparatus and instruments.docx

SFDA order No16 Methods of registration and administration for medical apparatus and instruments.docx

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SFDAorderNo16Methodsofregistrationandadministrationformedicalapparatusandinstruments

ACTSOFTHESTATEBUREAUOFFOODANDDRUGSUPERVISIONANDADIMINSTRATION

No.16

wasconsideredandpassedthoughthebureauaffairsconferenceoftheStateBureauofFoodandDrugSupervisionandAdministrationonMay28th,2004,nowitisissuedandgoesintoforcefromthedateofissue.

DirectorZhengXiao-yu

August9th,2004

MethodsofregistrationandadministrationformedicalapparatusandinstrumentsChapterIGeneralprovisions

Article1Thismethodwasstipulatedbasedonforthesickofstandardizationoftheregistrationandadministrationofmedicalapparatusandinstrumentsandinsuranceofsafetyandeffectivenessofthemedicalapparatusandinstruments.

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（SeeAppendix1ofthismethod）,whichwillbeusedtogetherwiththeregistrationcertificateofmedicalapparatusandinstruments.

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.

shallbecarriedoutfortheregistrationandtestofthemedicalapparatusandinstrumentabroad.

Article11Productstestedinthesameregistrationunitshallbethetypicalproductscapableofrepresentingthesafetyandeffectivenessofotherproductsinthesameregistrationunit.

Article12Thebiologicalcompatibilitytestforbiologyevaluationoftheproductsmaybeomittedfortheproducts,ofthesamecategory,madebythesamemanufacturerandwiththesamerawmaterials,duringre-registrationiftheproductiontechnologyandthedesiredusedkeepunchanged.

Thebiologicalcompatibilitytestforbiologyevaluationoftheproductsmaybeomittedfortheproductsofthesamecategory,madebythesamemanufacturerandwiththerawmaterialpassingthroughthebiologyevaluation,duringapplicationforregistrationiftheproductiontechnologiesandthedesiredusekeepunchangedorthereisnonewpotentialbiologyrisk.

Article13ProductsapplyingforregisteringmedicalapparatusandinstrumentofClass2andClass3andconcurrentlymeetingthefollowingrequirements,shallbeexemptedfromtheregistrationtest：

1）Thebasicprinciples,mainfunctions,structure,material