2019 - Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan

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