This document provides an overview of medical device regulation in Australia, including regulation of software as a medical device (SaMD). It discusses the four key steps in medical device regulation: 1) risk-based classification, 2) conformity assessment procedures, 3) inclusion in the Australian Register of Therapeutic Goods, and 4) post-market monitoring and reporting. International approaches to SaMD regulation from Europe, the US, and proposed reforms in Australia are also covered. The presentation aims to explain how SaMD is regulated based on its intended use and potential risks to ensure safety while allowing innovation.