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.
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:
- The personalised medical devices landing page
- Personalised medical devices (including 3D-printed devices)
- Custom-made medical devices landing page
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.
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].