What each vendor publishes about TGA status

    Whether a product is positioned inside or outside the TGA's software-as-a-medical-device rules is a statement the vendor makes. Most vendors we track do not publish a TGA position that we could find. We record the statement where it exists and mark the rest as not found. General TGA guidance on clinical decision support software is the reference point, and we do not interpret it for a specific product.

    1 of 39 vendors publish somethingLast checked 25 Sept 2026
    This tracker records only what each vendor has published on its own public pages. It is not an assessment, audit, certification or endorsement. Vendors change their documentation — always verify directly before making a procurement decision.

    What is on the public record

    What does i-scribe by Akuru (Akuru Clinical Intelligence) publish about TGA status?Ambient scribe
    SummaryChecked 25 Sept 2026
    Vendor states the product does not meet the definition of Software as a Medical Device (SaMD) and is exempt from TGA regulation.
    “It does not meet the definition of Software as a Medical Device (SaMD) and is exempt from TGA regulation.”
    www.i-scribe.com.au

    Answered from what the vendor publishes on its own public pages, or from an official register where noted, as at the check date shown. Not an assessment, audit, certification or endorsement.

    Not found on public pages

    We could not find this on the vendor's public pages as at the check date. This is not a statement that the vendor lacks the capability or has not disclosed it elsewhere.

    Other questions answered the same way

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    Something wrong or out of date?

    Are we missing something, or has this changed? Vendors and their representatives can submit a correction, and we note each change and credit the source. We review every correction request and update the entry when the source supports it.

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