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Apps that treat, diagnose or monitor a condition are likely to be subject to more stringent pre-market requirements under newly implemented reforms.
Standalone software (which is not attached to any physical medical device), commonly in the form of a mobile app, is increasingly becoming one of the means upon which we treat, diagnose or monitor a condition.
Such an app (if its intended purpose is medical and it is not an excluded product) may constitute a medical device (Software as a Medical Device or SaMD) under the Therapeutic Goods Act 1989 (Cth) and must be registered on the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia.
The documentation required to register SaMD onto the ARTG will depend on its risk classification, and there have been changes to the way SaMD is classified since 25 February 2021.
Importantly, if your SaMD has already been registered on the ARTG, you will have until 25 August 2021 to re-apply for ARTG entry (and as part of that, re-assess your SaMD under the new classification rules) or notify the Therapeutic Goods Administration to get more time to do so.
New classification rules applying to SaMD have been inserted into the Therapeutic Goods (Medical Devices) Regulations 2002. SaMD covered by the amended regulations includes software that:
(a) recommends treatment or intervention (e.g. specifying exercises to treat a back pain injury);
(b) screens or diagnoses a condition (e.g. melanoma detector);
(c) provides therapy through provision of information (e.g. posture corrector providing exercise instructions); and
(d) monitors a condition (e.g. monitoring sleep to predict risk of sleep apnoea).
Previously, no specific classification rules applied to SaMD so it was typically classified under the general non-invasive category in Class I (lowest risk classification with less stringent pre-market requirements) regardless of the risk of harm.
Under the new classification rules, SaMD may be classified under a higher classification (being Class II or III) which will be subject to stricter pre-market requirements depending on (i) which type of SaMD it is ((a) to (d) above), (ii) the risk of harm to the individual or public health and (iii) whether the intended user is an individual or a health professional.
Generally, your SaMD may be classified under Class I if your app presents no risk of harm to the individual or public health. However it might now be subject to a higher classification where:
It is likely that various SaMD in the market will now be subject to a higher classification. For example, an app that specifies exercises to treat a back pain injury (type (a) above) to an individual (rather than a health professional) may now be subject to Class II or III simply by virtue of its type and its intended user.
Accordingly it is important that you promptly re-assess the classification that applies to your SaMD as it may now be subject to a higher classification (Class II or III). Classes II and III are subject to more stringent requirements, such as an external conformity assessment, prior to ARTG inclusion and this may impact on your SaMD launch timeframe in Australia.
As noted above, if your SaMD has already been registered on the ARTG (or you have already applied for registration) before 25 February 2021, you will need to re-apply for inclusion into the ARTG, but a grace period applies (so you have until 1 November 2024 to re-apply) provided that you notify the Therapeutic Goods Administration by the later of 25 August 2021 or two months from the ARTG entry.
If you are seeking to make available SaMD in Australia and it has not been entered into the ARTG before 25 February 2021, you will need to assess the SaMD against the new classification rules when you apply for ARTG inclusion.
There are also changes to the essential safety and performance principles which apply to the conformity assessment and may further impact your timelines.
Thank you to Steven Cirson and Jessica Bi for their assistance in preparing this article
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