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July 2024
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.
Region: Australia
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