template of declaration of conformity - health sciences 的符合性声明模板健康科学

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1、Formno.DOC-v1/11DECLARATIONOFCONFORMITY[TobeprintedonCompanyLetterheadofProductOwner]NameandAddressofProductOwner:WeherebydeclarethatthebelowmentioneddeviceshavebeenclassifiedaccordingtotheclassificationrulesandconformtotheEsse

2、ntialPrinciplesforSafetyandPerformanceaslaidoutintheHealthProducts(MedicalDevices)Regulations.MedicalDevice(s):ManufacturingSite:RiskClassification:e.g.ClassB,rule6/ClassA,rule1

3、dingtotheclassificationrule,andtheruleusedtodeterminetheclassification>QualityManagementSystemCertificate:ForClassB,ClassCandClassDmedicaldevices,declarationofconformitytoeitherofthefollowingQMSstandardsismandatory:-·I

4、SO13485·USFDAQualitySystemRegulations·JapanMHLWOrdinance169ForClassAmedicaldevicesthatarenotmanufacturedundereitheroftheabovementionedQMSstandards,certificationobtainedforalternativeQMSstandards(e.g.ISO9001)shallbelistedinthissection,ifapplicable.ForClassAmedicaldevicesthatdono

5、tholdthefollowingQMScertifications:-·ISO13485·USFDAQualitySystemRegulations·JapanMHLWOrdinance169anattestationthataqualitymanagementsystemhasbeenestablishedshallbesubmittedinplaceofsupportingdocumentsrequiredfortheabovementionedQMSstandards.TheattestationshallbemadebytheProduct

6、Owner.Thetemplatefortheattestation(FormNo.QMS-A-V1/11)hasbeenprovidedbelow.StandardsApplied:ThisdeclarationofconformityisvalidfromAuthorisedSignatory:_____________________________

7、___________________Name,PositionDateFORMNO.QMS-A-V1/11QUALITYMANAGEMENTSYSTEMSATTESTATIONTEMPLATE[TobeprintedonCompanyLetterheadofProductOwner]MedicalDeviceBranchHealthProductsRegulationGroupHealthSciencesAuthority[Date]DearSir/Madam,Subject:QualityManagementSystemsAttestationW

8、eattestthatthemanufacturer(s)ofthemedicaldeviceslisted