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, with a few exceptions.
If you are importing materials, components or devices or manufacturing devices with materials not already on the ARTG and exceed the exemption for very low volumes of up to five (5) devices, you will need to submit a notification and application for transitional arrangements by 25 August 2022.
You can find detailed information including a step-by-step guide with screenshots in the Submitting a custom-made medical device / patient-matched medical device transition notification Guide provided by the TGA.
The TGA’s new, improved custom-made medical device database requires you to use a valid GMDN code. GMDN code tables are available in the database for you to search and you can also refer to the ASO GMDN Code table and ASO Guide for details.
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].