Software as Medical Device (TGA)


The TGA transition period for software-based medical devices that met the regulatory changes set on 25 February 2021 ends on 1st November 2024. You will have until 1st November 2024 to apply for a conformity assessment with the TGA and to include your device in the ARTG list under the new, higher classification. 

Contact us to help you with this transition and to assist you with TGA conformity assessment.