Description
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
*10% GST is added if we are billing an Australian company
