The Australian Government is undertaking a significant program of reform to 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. We have issued this consultation paper as part of the reform program.
In 2015, the Report of the Expert Panel Review of Medicines and Medical Devices Regulation (MMDR) made 58 recommendations for reform of the regulatory framework for medicines and medical devices in Australia. The Australian Government Response to the Review of Medicines and Medical Devices Regulation was released in September 2016. The Government accepted 56 MMDR recommendations including Recommendation Twenty which provided that the regulation of medical devices, wherever possible and appropriate, align with the European Union (EU) framework including the classification of medical devices.
The EU introduced a new medical device regulatory framework from 2017, which included new requirements around nanomaterials. This paper examines whether the Australian medical device regulatory framework should be aligned to the EU framework for medical devices containing nanomaterials, and how this could occur.
European regulatory changes on nanomaterials in medical devices has prompted consideration of nanomaterials in the context of the Australian regulatory framework. The EU Regulation on medical devices (2017/745) (EU MD Regulation) included several changes to:
In this consultation we are seeking your views on:
For further background and information, please refer to the consultation paper Proposed regulatory options for medical devices containing nanomaterials, downloadable via a link at the bottom of this page.
We invite you to complete our online survey (click on the link below).
If you prefer, 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.
Submissions will be reviewed by the TGA. A summary of responses will be published and all submissions will be placed on this website (unless marked confidential or indicated otherwise in the survey or submission form).
Outcomes from the consultation will be provided to the Government for consideration.
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