Areas Covered in the Webinar: Introduction and Agenda Review Medical Device Single Audit Program MDSAP: Overview, History, Audit Process and Report U.S. FDA – Overview of Medical Device Regulations Device Classification, Licensing Pathways, Human Factors and Usability Studies, Medical Device GMP, Inspection Process, Device Labeling, Combination Products, License Holder Responsibilities NOTE: Each country session will follow a similar format to the information above Canada – Overview of Health Canada Medical Device Regulations Brazil -- Overview of ANVISA Medical Device Regulations Australia – Overview of TGA Medical Device Regulations Japan – Overview of PMDA Medical Device Regulations Working with Country Regulators Q&A Session