To download the files, use the links below. Attachment(s): Download file Australias_Experience_Aligning_Regulatory_Requirement.pdf EU_Conformity_Assessment_Procedures_and_STED_Requirements.pdf Global_Regulatory_Model_and_GHTF_STED_Requirements.pdf Revision_of_Japans_Pharmaceutical_Affairs_Law.pdf Risk_Based_Classification_of_Medical_Devices_in_EU.pdf US_FDAs_Third_Party_Programs.pdf