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1、1Tentativetranslationver.3.1(asof5September2005)MHLWMinisterialOrdinanceNo.169,2004InaccordancewiththeprovisionsofItem(4)ofParagraph2ofArticle14andItem(4)ofParagraph2ofArticle14appliedmutatismutandisunderParagraph5ofArticle19-2ofPharmaceuticalAffairsLaw(LawNo.145,19
2、60),MHLWMinisterialOrdinanceonStandardsforManufacturingControlandQualityControlforMedicalDevicesandIn-vitroDiagnosticReagentsisestablishedasfollows.17December2004HidehisaOTSUJIMinisterofHealth,LabourandWelfareMinisterialOrdinanceonStandardsforManufacturingControland
3、QualityControlforMedicalDevicesandIn-vitroDiagnosticReagentsCONTENTSChapter1GeneralProvisions(Articles1to3)Chapter2ManufacturingControlandQualityControlinManufacturingSitesofMedicalDeviceManufacturers,etc.Section1GeneralRules(Article4)Section2QualityManagementSystem
4、(Articles5to9)Section3ManagementResponsibility(Articles10to20)Section4ResourceManagement(Articles21to25)Section5ProductRealisation(Articles26to53)Section6Measurement,AnalysisandImprovement(Articles54to64)Chapter3ManufacturingControlandQualityControlinManufacturingSi
5、tesofLabelling,etc.-CategoryMedicalDeviceManufacturers,etc.(Articles65to72)Chapter4ManufacturingControlandQualityControlinManufacturingSitesofBiological-originMedicalDevice,etc.Manufacturers,etc.(Articles73to79)Chapter5ManufacturingControlandQualityControlinManufact
6、uringSitesofIn-VitroDiagnosticReagentsManufacturers,etc.(Article80)SupplementaryProvisions1Note/Thisisatentativetranslationofafore-mentionedOrdinanceinEnglishwhichisnotanauthenticandnotformallyautholisedbyMinistryofHealth,LabourandWelfareofJapan.1Chapter1GeneralProv
7、isionsSection1GeneralRules(Purpose)Article1ThisMinisterialOrdinanceshallprovidethestandardsinaccordancewiththeprovisionofItem(4)ofParagraph2ofArticle14(includingthecasewhereitisappliedmutatismutandisunderParagraph5ofArticle19-2,andhereinafterreferredtoassuch)ofPharm
8、aceuticalAffairsLaw(LawNo.145,1960)(hereinafterreferredtoas“Law”)whichprovidesthatsuchstandardsshallbeprovidedbyMHLWMinisterialOrdinances.
