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.

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.

Latest update

3/09/21

We have received confirmation from the TGA that the advocacy efforts of the ASO and the Dental Sector Working Group have been successful, and the requirement for orthodontists to register patient-matched medical devices by the 25 August has been removed, unless you are importing materials, components or devices or manufacturing devices with materials not already on the ARTG. You can find a summary of the changes here.

If you will no longer need to transition because of these changes, you do not need to take any further action now. We are working directly with the TGA to understand the full details and will provide updates here as this becomes available.

If you are importing materials, components or devices or manufacturing devices with materials not already on the ARTG, please follow the steps below. If you have missed the deadline, please submit your notification ASAP.

Step 1: Submit the notification form asap

You will need to have completed the online form notifying the TGA that you are supplying this kind of device before you can proceed to Step 2.

You can find more information about common orthodontic kind of devices, GMDN codes and classifications in the ASO TGA Guide and GMDN Code table in the ASO Resources tab.

Step 2: Submit the application for transitional arrangements asap

Please refer to the Step-by-Step guide for details how to complete the transition notification form which is quick and easy to use. The benefit of submitting means that the personalised medical devices to which the notification relates will not require inclusion in the Register for the duration of the transition period.

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 (1st step)
ASO step-by-step guide
GMDN Code Table

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