TGA - regulatory changes to custom-made medical devices

The TGA is changing the way that custom-made medical devices are regulated in Australia.

These changes affect anyone who is manufacturing, importing or supplying custom-made medical devices, including healthcare providers, which means that these changes will affect orthodontists and orthodontic laboratories. 

The ASO is currently working with the TGA to understand more about the new personalised devices framework and the impact this will have on orthodontists and orthodontic practices.

We are aware of the breadth and complexity of the information relating to these changes and are working to make this as clear and accessible as possible for members. To this end, we have created major areas below that contain advice, interpretation and guidance along with relevant links and other resources.

We will be updating these sections constantly as we progress through these regulatory changes, so please check back often for updates.

The ADA has created a private online community for dental technicians to connect and discuss how the changes will impact them. Technicians interested in joining the online community can do so by completing this online form: https://bit.ly/3wQO8VH

Latest update

The ASO is continuing to work closely with other dental sector stakeholders and the TGA regarding potential refinements to the new framework for the regulation of personalised medical devices.

The Dental Sector Working Group submitted feedback on the proposed refinements, and we continue to push for reduced regulatory requirements and a more simplified process for orthodontic devices based on their extremely low risk to patient safety.

The good news is that based on the proposed refinements, it is clear that the TGA have heard our concerns and are prepared to work with us to reduce or remove any unnecessary regulatory burden on the dental sector. We will of course inform members once we have further clarity regarding any confirmed changes to the framework.

In the meantime, the 25 August 2021 deadline to notify the TGA of custom-made medical devices and to apply for transition still stands. Therefore, we recommend that members who are impacted by the regulatory changes complete the TGA online notification and transition forms based on the information we have today.

We will continue to advocate on your behalf and as the situation continues to develop, it is likely that there will be changes which will be favourable for orthodontists and the dental sector. However, we still recommend that members affected by the changes submit the online notification and transition forms as soon as possible. Please note, you will not be compelled to move forward with listing your device in the ARTG if the TGA guidelines change or if you decide not to proceed with listing it at a later date.

To assist you in completing the online transition form, we have developed guidance for members in relation to orthodontic devices, GMDN codes and the classification of devices. We have also developed a step-by-step guide for completing the TGA online transition form. These are suggestions based on the current framework and information available today.

You will find the relevant links and guidance under the ASO Resources tab below. If, after reading the information you have any questions, please email  [email protected]. You can also contact the TGA directly for further guidance or with any questions by emailing [email protected].

An overview of the changes to custom-made medical devices.

What these changes mean for orthodontists and where you will and won't need to take action.

How to start assessing your devices and determining who is responsible for fulfilling the regulatory requirements.

Key dates and deadlines for submitting information to the TGA so you can continue to use your devices.

ASO TGA Guide
ASO step-by-step guide
GMDN Code Table

Useful resources and quick links to information and forms on the TGA website.