The Therapeutic Goods Administration has released its Action Plan for Medical Devices. The Action Plan is made from a three-part strategy than plans to further strengthen Australia’s regulatory requirements.
Bearing in mind what are key issues for the dental industry, the TGA’s 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 as well as the proposed actions and the time frames for these.
It will fast track the 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.
The TGA advises that although involving consumers in the process is critical, it notes 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 action outlined in the Action Plan could be implemented as well as engaging and consulting with consumers and other stakeholders so that they have input in the implementation of the Action Plan.
An emphasis of the Action Plan is to introduce more transparency by the TGA, and that greater scrutiny occurs throughout the whole device lifecycle.