D IMDRF Membership Criteria and Roles MC Member Official Observer Invited Observer Regional Harmonization Initiatives (RHIs) Criteria Must be a Regulatory Must be a Regulatory Must be a regulatory Must be Authority Authority authority or global associations/initiatives A regional influence Regulatory Authority should industry or stakeholder comprising medical Must have been an operate a mature system for association device regulatory Official Observer for at medical device regulation Perceived contribution authorities least the last three (3) should include: or value to IMDRF representing the consecutive years prior Established laws and meetings majority of countries to the application for A regulatory authority in a certain region/area regulations for membership should have a mature of the world medical devices Must have participated or maturing system for Must have mandate of building in all IMDRF MC medical device regional harmonization substantially on meetings (including regulation or amongst its members GHTF and IMDRF teleconferences) for the contribution Must have a foundations and last 3 consecutive years to medical device demonstrated interest principles Must have participated regulation in medical device Proper competencies in in a majority of regulatory activities for effective WGs as an Official that are directly related implementation and Observer, providing to the common of enforcement of the active contribution for fostering global established laws and the last 3 consecutive regulatory regulation years. convergence, A system for leveraging resources conformity and making available assessment of safe and effective devices building on medical devices GHTF and IMDRF globally guidance documents
D IMDRF Membership Criteria and Roles MC Member Official Observer Invited Observer Regional Harmonization Initiatives (RHIs) Criteria Must be a Regulatory Authority A regional influence Must have been an Official Observer for at least the last three (3) consecutive years prior to the application for membership Must have participated in all IMDRF MC meetings (including teleconferences) for the last 3 consecutive years Must have participated in in a majority of WGs as an Official Observer, providing active contribution for the last 3 consecutive years. Must be a Regulatory Authority Regulatory Authority should operate a mature system for medical device regulation should include: Established laws and regulations for medical devices building substantially on GHTF and IMDRF foundations and principles Proper competencies for effective implementation and enforcement of the established laws and regulation A system for conformity assessment of devices building on GHTF and IMDRF guidance documents Must be a regulatory authority or global industry or stakeholder association Perceived contribution or value to IMDRF meetings A regulatory authority should have a mature or maturing system for medical device regulation or contribution to medical device regulation Must be associations/initiatives comprising medical device regulatory authorities representing the majority of countries in a certain region/area of the world Must have mandate of regional harmonization amongst its members Must have a demonstrated interest in medical device regulatory activities that are directly related to the common of fostering global regulatory convergence, leveraging resources and making available safe and effective medical devices globally
imdrf-proc-171127-sop.docx