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Michelle Keane Eoin Philip Kelly At the end of this short course, successful learners will be able to: Understand the TGA’s regulatory framework for medical devices, including device classification and regulatory controls Identify requirements for ARTG inclusion, including evidence requirements and conformity assessment procedures Apply Australian labelling and advertising requirements, including consumer health protection laws Understand obligations of sponsors, including post-market monitoring, incident reporting, and recalls Navigate the role of MDSAP, international equivalence, and current regulatory reforms This course is for individuals or organizations who want to understand Australia TGA Medical Device Regulatory Requirements