医用耗材核酸检测

ISO13485:2016医疗器械质量管理体系标准实施指南

国家药监局《医疗器械生物学评价指导原则》

AAMITIR42:2016核酸相关医疗器械评价规范

CNAS-CL02-A009医学实验室质量和能力认可准则

SAC/TC136全国医用临床检验实验室和体外诊断系统标准化技术委员会文件汇编

AACC临床实验室标准化研究院（CLSI）EP系列文件

TheUnitedStatesPharmacopeia(USP)GeneralChapters

TheInternationalCouncilforHarmonisation(ICH)Q2(R2)Guideline

TheEuropeanPharmacopoeia(Ph.Eur.)BiologicalTests

TheJapanesePharmacopoeia(JP)GeneralTests

TheBritishPharmacopoeia(BP)Appendices

TheInternationalOrganizationforStandardization(ISO)TechnicalReports

TheAmericanSocietyforTestingandMaterials(ASTM)Standards

TheClinicalandLaboratoryStandardsInstitute(CLSI)Guidelines

TheCollegeofAmericanPathologists(CAP)Checklists

TheInternationalFederationofClinicalChemistry(IFCC)Recommendations

TheWorldHealthOrganization(WHO)TechnicalReportSeries

TheEuropeanDirectoratefortheQualityofMedicines&HealthCare(EDQM)Guidelines

TheNationalInstituteofStandardsandTechnology(NIST)ReferenceMaterials

TheFoodandDrugAdministration(FDA)GuidanceDocuments

TheEuropeanMedicinesAgency(EMA)ScientificGuidelines

ThePharmaceuticalsandMedicalDevicesAgency(PMDA)Standards

TheTherapeuticGoodsAdministration(TGA)RegulatoryRequirements

TheHealthSciencesAuthority(HSA)TechnicalGuidance

TheMedicalDeviceCoordinationGroup(MDCG)PositionPapers

TheGlobalHarmonizationTaskForce(GHTF)StudyGroupsDocuments

TheInternationalMedicalDeviceRegulatorsForum(IMDRF)Reports

TheAsianHarmonizationWorkingParty(AHWP)TechnicalDocuments

ThePanAmericanHealthOrganization(PAHO)TechnicalNotes

TheAfricanMedicinesRegulatoryHarmonization(AMRH)InitiativePublications

TheGulfCooperationCouncil(GCC)RegulatoryGuidelines

TheASEANMedicalDeviceDirective(AMDD)ImplementationFramework

TheEurasianEconomicUnion(EAEU)TechnicalRegulations

TheSouthernAfricanDevelopmentCommunity(SADC)HarmonizedRequirements

TheEastAfricanCommunity(EAC)MedicalDeviceRegulations

TheWestAfricanHealthOrganization(WAHO)StandardsCompendium

TheAsia-PacificEconomicCooperation(APEC)RegulatoryCooperationPlan

TheOrganisationforEconomicCo-operationandDevelopment(OECD)ConsensusDocuments

TheInternationalAccreditationForum(IAF)MandatoryDocuments

TheInternationalLaboratoryAccreditationCooperation(ILAC)Guidelines

TheJointCommissionInternational(JCI)AccreditationStandards

TheNationalAccreditationBoardforTestingandCalibrationLaboratories(NABL)Criteria

TheChinaNationalAccreditationServiceforConformityAssessment(CNAS)Rules

TheAmericanAssociationforLaboratoryAccreditation(A2LA)Requirements

TheUnitedKingdomAccreditationService(UKAS)TechnicalBulletins

TheDeutscheAkkreditierungsstelle(DAkkS)Regulations

TheComitFranaisd'Accrditation(COFRAC)Directives

TheJapanAccreditationBoardforConformityAssessment(JAB)Standards

TheKoreaLaboratoryAccreditationScheme(KOLAS)Manuals

TheSingaporeAccreditationCouncil(SAC-SINGLAS)Criteria

TheHongKongAccreditationService(HKAS)GuidanceNotes

TheTaiwanAccreditationFoundation(TAF)DocumentationSystem.

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