TGA Releases New Action Plan for Medical Devices
4th Apr 19
The Therapeutic Goods Administration (TGA) 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.
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 timeframes 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.
For further information click on the link below:
TGA Action Plan for Medical Devices
Member Engagement —
The ADIA Policy Team receives advice and guidance on matters concerning dental product regulation from members serving on the ADIA-PRPC Product Regulation Policy Committee.
Further Information —
To keep up to date with all matters associated with dental product regulation follow ADIA on Facebook at www.facebook.com/dental.industry or the Twitter feed @AusDental. For further information on ADIA's engagement with the TGA on regulation send an email to firstname.lastname@example.org or telephone 1300 943 093.
Currency & Disclaimer —
This update was issued on 4 April 2019 and please note that changes in circumstances after the publication of material or information may impact upon its accuracy and also change regulatory compliance obligations. The statements, regulatory and technical information contained herein are believed to be accurate and are provided for information purposes only. Readers are responsible for assessing its relevance and verifying the accuracy of the content. To the fullest extent permitted by law, ADIA will not be liable for any loss, damage, cost or expense incurred in relation to or arising as a result of relying on the information presented here.
This publication is available for your use under a Creative Commons Attribution 3.0 Australia licence, with the exception of the ADIA logo, other images and where otherwise stated.
1st Feb 18
Thanks to ADIA's advocacy, the dental industry looks set to escape a proposed TGA reform that would require patient information 'cards' to be provided to patients, a reform that ignores advances in electronic patient records.
8th Oct 18
The Medical Devices Small Business Coalition (MDSBC) will be formally launched by the Health Minister on 15 October 2018 at parliament house.