Regulatory Changes for Software-Based Medical Devices

The Therapeutic Goods Administration (TGA) has updated its regulations for software-based medical devices, including software as a medical device (SaMD). These changes, effective from 25 February 2021, encompass:

– New Classification Rules: Updated rules and boundaries for software-based medical devices.
– Requirements for Exclusions and Exemptions: Clarifications on which software-based medical devices are excluded or exempt, including those that:
  – Provide a diagnosis or screen for a disease or condition
  – Monitor the state or progression of a disease or condition
  – Suggest or recommend a treatment or intervention
  – Provide therapy through the provision of information

Transition Arrangements:
– Re-classification: If regulatory changes lead to the re-classification of a software-based medical device already listed in the ARTG, sponsors can use transition arrangements to continue supplying the device.
– Application Process: Sponsors must apply to include the device in the ARTG under the new, higher classification.

Source: https://www.tga.gov.au/resource/regulatory-changes-software-based-medical-devices##~https://www.tga.gov.au/sites/default/files/2024-07/regulatory-changes-software-based-medical-devices.pdf

Region: Australia