Whilst the regulatory requirements in Australia are some of the most stringent in the world, more can be done to further strengthen the system, placing patient safety first.
The Action Plan is a three part strategy to:
improve how new devices get on the market in Australia
strengthen monitoring and follow up of devices already in use
provide more information to patients about the devices they use
The Action Plan provides an overview of the current regulatory system, what actions are proposed and the timeframes for these.
It will fast track TGA's implementation of medical device reforms already underway and consult on new ways to improve transparency and increase public and health professional confidence in the regulatory system. Involving consumers in the process is critical, noting that decisions on new policies or changes to the Therapeutic Goods Act will be required from the Parliament prior to potential implementation.
The TGA has been tasked with providing more detail on how the actions outlined in the Plan could be implemented, engage and consult with consumers and other stakeholders so that they have input to implementation.
An emphasis of the Plan is to introduce more transparency by the TGA and that greater scrutiny occurs throughout the whole device lifecycle.
More detailed information on each of the strategies in the Plan and proposed consultations will be published in the near future on the TGA website.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.