The Therapeutic Goods Administration (TGA) Australia has published the latest document on personalised medical devices, including 3D-printed devices, in November 2021.
For patient-matched medical devices, manufacturers and suppliers are exempt from the requirement to include the device in the Australian Register of Therapeutic Goods (ARTG) if the supply is less than five (5) medical devices. However, all the other regulatory prerequisites pertaining to medical devices will need to be fulfilled. This is called a low volume exemption.
The updates were based on the regulation changes under the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 under the Medical Devices Surveillance Branch.
More details can be found in “Personalised medical devices (including 3D-printed devices), November 2021”: https://www.tga.gov.au/resource/personalised-medical-devices-including-3d-printed-devices