TGA - regulatory changes to custom-made medical devices

The TGA has changed 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 affect orthodontists and orthodontic laboratories.

Latest update

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 can find detailed information including Step-by-step instructions for how to submit a custom-made medical device / patient-matched medical device notification 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.

Please contact the TGA directly for further guidance or with any questions by emailing [email protected].

How to start assessing your devices and determining who is responsible for fulfilling the regulatory requirements.

ASO Guide
ASO GMDN Code table

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