Global Medical Device Regulatory Requirements – Australia (2 hours)

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

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.