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Consultation: Proposed regulatory options for medical devices containing nanomaterials

26 February 2021

This consultation closed on Wednesday, 9 April 2021.

The Australian Government is undertaking a significant program of reform to the regulation of therapeutic goods in Australia. The reforms will continue to improve the safety, performance and quality of medical devices in Australia and improve health outcomes for patients who require medical devices. 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.

We invite you to review the consultation paper and provide a response using our online survey, both of which are accessible through our consultation hub. We appreciate all views, so if you would prefer to respond by email or written document, you can find further details on the hub.