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 TGA has released a consultation paper with proposed refinements to the Personalised Medical Devices regulatory framework, which members can access here. Our CEO and President are continuing to work closely with the Dental Working Group and the TGA on this important issue and are reviewing the consultation paper so that we can provide further feedback. At this stage, the 25 August 2021 deadline for manufacturers and sponsors to notify and apply for transition (two separate steps) for inclusion of personalised medical devices in the ARTG currently still stands. We continue to push for this deadline to be extended, however, to date the TGA have not indicated that this will change and therefore we recommend that all members still work towards applying before 25 August if they are impacted by the regulatory changes. The ASO will provide more detailed advice on how to complete the initial forms, including recommended GMDN codes and classifications for various appliances as soon as we have further clarity from the TGA.

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.

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