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

9/11/21

Due to the advocacy efforts of the ASO and Dental Sector Working Group the requirement for orthodontists to register patient-matched medical devices has been removed, unless you are importing materials, components or devices or manufacturing devices with materials not already on the ARTG (see steps below).

The TGA provided the latest amendment which:

  • Extends the deadline for stakeholders to register a patient-matched medical device for transition to inclusion in the Australian Register of Therapeutic Goods by 12 months to 25 August 2022.
  • Introduces an exemption for patient-matched medical devices that are supplied in very low volumes, allowing the supply of up to five (5) devices a year without an inclusion in the ARTG.

You can find more details about the latest refinements here:

If you are importing materials, components or devices or manufacturing devices with materials not already on the ARTG please follow these steps by 25 August 2022:

Step 1: Submit the notification form 

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

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.

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.