You are here

An Action Plan for Medical Devices

Improving Australia’s medical device regulatory framework
4 April 2019
Download An Action Plan for Medical Devices


This Action Plan is a three part strategy to strengthen Australia’s regulatory system whilst continuing to be patient focused and have greater transparency. It outlines actions that continue to improve the safety, performance and quality of medical devices in Australia and improve health outcomes for patients who require medical devices.

Strategy 1: Improve how new devices get on the market

Strategy 2: Strengthen monitoring and followup of devices already in use

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

The Action Plan describes:

  • a number of reform activities currently underway that the TGA will implement sooner; and
  • additional ways to improve transparency and to increase public confidence in Australia’s medical device regulatory system. The TGA will actively seek feedback on new ways to do these.

We aim to provide documents in an accessible format. If you are having problems using a document with your accessibility tools, please contact us for help.