CONF-16-Richard-Bancroft.pdf

1、Alignment of Global Medical Device Standards&TheirAcceptability for RegulatoryPurposesRichard BancroftSTERIS,Chair,ISO/TC 198Scott ColburnUS FDA,Chair,ISO/TC 210AcknowledgementThanks to Scott Colburn,U.S.FDA,who contributed to the scope and content of this presentation.FDA disclaimer:The views and o

2、pinions presented here represent those of the speakers and should not be considered to represent advice or guidance on behalf of the U.S.Food and Drug AdministrationContentsUse of standards Benefits WTO Alignment of regulatory principlesNational®ional standards,&primacy of international standards

3、 for relation to legal requirementsPotential risks to global standards Understanding and mitigating those risksConclusionBenefits of StandardsBarriers to global trade can be minimized by uniform technical standards The World Trade Organization(WTO)encourages use of international standards where they

4、 exist1International standards should take precedence over national standards,because international standards can be used to align multiple nations standards Can be used to meet regulatory requirementsVoluntary unless explicitly stated in a regulation(i.e.,harmonised symbols in MDR,13485 in FDA QMSR

5、1.World Health Organization,Article 20,General Agreement on Tariffs and TradeUse of StandardsBenefits to use of Standards Alignment with regulatory&customer expectations Less data and technical documentation needed to be provided to regulatory bodies Facilitates procurement&tender processes Tried&te

6、sted best practices help ensure complianceImplications of not using Standards Delays in device approval due to missing features or requirements Competitive disadvantage Restricts access to markets More cost,time and resource Decreased user confidenceStandards and WTOTransparencyInformation regarding