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.

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.