1.42. Australian Medical Device Classification

Written and presented by Gary Burgess, Director and Principal Consultant at Hill Valley Regulatory Consulting, and previously a senior manager at TGA and Australian manufacturers of active implantable medical devices. This is an intermediate course giving a more detailed review of the classification of medical devices in Australia, and why it is so important to medical device developers, manufacturers and suppliers.

• Background to medical device classification
• Basics of classification in Australia
• Rules for non-invasive devices
• Rules for invasive devices
• Rules for active devices
• Special classification rules
• Rules for in vitro diagnostic (IVD) devices
• Guidance on classification

Duration: 1 hr