TGA Changes to the Regulation of Custom-Made Medical Devices

The Therapeutic Goods Administration (TGA) regulates personalised medical devices, which include many pedorthic devices such as custom shoes and orthoses. A dedicated framework for these devices commenced on 25 February 2021, changing how custom-made medical devices are defined, manufactured, supplied, and reported.

This framework affects anyone who manufactures, imports, or supplies personalised medical devices. Pedorthists may need to have their devices included in the Australian Register of Therapeutic Goods (ARTG), depending on the type and volume of devices supplied.

For the most up-to-date information, please visit the TGA’s Personalised Medical Devices webpage.

The Pedorthic Association of Australia will continue to work with the TGA to share relevant updates and resources with members, including educational opportunities and guidance specific to pedorthic practice.