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Medical devices reforms

17 February 2021

The Medical Devices Reforms aim to enhance the safety, performance and quality of medical devices in Australia and focus on patient safety.

About the Reforms

The Australian Government is undertaking a significant program of reforms to strengthen the regulation of medical devices in Australia.

Read more about the regulatory changes.

An Action Plan

An Action Plan for Medical Devices provides an overview of the reforms grouped under three strategies.

Read more about the Action Plan.

Strategy 1: Improve how new devices get on the market

Strategy 2: Strengthen monitoring and follow-up of devices already in use

Strategy 3: Provide more information to patients about the devices they use

Consumer information

An Action Plan Consumer Working Group (representing consumer groups) continues to work closely with the TGA, guiding and providing feedback into the Reforms, and to develop a range of consumer-focused products about medical devices.

This includes resources on surgical mesh, cyber security, cosmetic injections and breast implants, and the fact sheet Five questions to ask your health professional before you get a medical implant.

Keep up to date

Please contact the TGA at if you have any queries or comments.

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For more information about other reforms visit Medical devices reforms.