The Australian government endorsed a significant program of reform to further strengthen the regulation of medicines and medical devices in Australia. As part of the Australian government, Department of Health, the TGA regulates these products, and is responsible for implementing the government reforms.
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[1] which addressed matters within the remit of the TGA. This Recommendation provided that the regulation of medical devices, wherever possible and appropriate, align with the European Union (EU) framework.
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[1] which addressed matters within the remit of the TGA. This Recommendation provided that the regulation of medical devices, wherever possible and appropriate, align with the European Union (EU) framework.
This consultation focuses on the proposed changes to the essential principles for safety and performance of medical devices. The changes set out in this consultation are intended to facilitate better regulatory compliance and consequently improve safety and quality of medical devices, through alignment with international best practice.
Interested parties should respond by close of business Thursday, 17 October 2019.
Submissions must be relevant to the proposed amendments and questions detailed within the consultation paper.
How to participate?
Complete the online consultation submission form to upload your submission in either pdf or word format.
Alternatively, hardcopy submissions with a printed cover sheet may be mailed to:
Medical Devices Reform Unit
Medical Devices Branch
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
