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Australia Medical Device Regulations – A Comprehensive Overview

About This eLearning

This two-hour course provides a comprehensive overview of medical device regulatory requirements including the regulatory framework, pre- and post-market requirements, and the way Australia is utilizing MDSAP.

Key Learning Objectives

By the end of this course, you will be able to:

  • Understand the legal and regulatory framework for manufacturing, marketing and distributing medical devices in Australia
  • Distinguish how different medical devices are classified
  • Understand the Medical Device Single Audit Program (MDSAP) and its function in Australia
  • Understand the premarket pathway(s) and requirements for medical devices
  • Understand the quality management system regulations required to market a medical device in Australia
  • Understand the post-market requirements for medical devices in Australia

Who Should Attend

This course is essential for anyone wanting to bring a medical device or IVD to market in Australia, and also for employees in R&D, regulatory, quality and compliance functions.


By completing/passing this Australia medical device regulations course, you will attain the Medical Device Certificate.

Challenging and interesting course!