The Australian Government is undertaking a significant program to reform the regulation of therapeutic goods in Australia. As part of the Australian Government Department of Health, the Therapeutic Goods Administration (TGA) regulates therapeutic goods, and is responsible for implementing the Government’s reforms. The TGA has issued this consultation paper as part of the Government’s reform program.
The purpose of this consultation paper is to seek feedback on proposals that aim to enhance Australia’s medical device adverse event reporting system.
A range of reviews and inquiries have identified that the existing adverse event reporting system can be improved further. Hence, this consultation seeks feedback on five proposals that aim to enhance the adverse event reporting system and improve access to safety information related to medical devices.
We invite you to provide your feedback by completing our online survey (click on the link below) or you can make a submission directly to the Department via post or email at the following addresses:
Medical Devices Reform Unit
Medical Devices Branch
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
If you choose to do this, you may download the MSWord version of the consultation paper to use as a template for your response. Please also download and complete a copy of the Cover Sheet. Both are available via links at the bottom of this page.
This webinar aims to provide targeted information to sponsors, manufacturers and distributors of medical devices about the proposed enhancements to adverse event reporting.
The focus of this webinar will be on proposal 1, 2, 4, and 5.
This webinar aims to provide targeted information to consumers of medical devices about the proposed enhancements to adverse event reporting.
The focus of this webinar will be on proposal 1, 2, 4, and 5.
This webinar aims to provide information about a proposal to introduce a new program whereby the TGA would actively inspect and/or audit medical device sponsors’ systems for how they identify, report and manage their post market reporting obligations.
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