1.43. Interacting with TGA for Medical Devices

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 introductory to intermediate course giving an overview of the main situations in which sponsors or manufacturers of medical devices will need to interact with the TGA, as well as an insight into how best to communicate with the TGA to ensure regulatory compliance.

• Receiving and responding to TGA requests for information
• Appealing TGA decisions
• Lodging annual reports for high-risk medical devices
• Submitting medical device incident reports

Duration: 34 min