The following article deals with the latest update for Software as Medical Device by The Australian TGA (Therapeutic Goods Administration). Software based Medical Devices (SaMD’s) are regulated by the TGA and must be included in the Australian Register of Therapeutic Goods (ARTG), unless they have been excluded. Changes to the regulations for software based medical devices took effect from 25 February 2021, including a transition period for those already included in the ARTG.
Any distributor or manufacturer of software must go through these regulations to understand the regulatory requirements. As per the TGA, the following are considered to be a Medical Device Software if they come under the following
- Diagnosis, prevention, monitoring, prediction, prognosis or treatment of a disease, injury or disability
- Alleviation of or compensation for an injury or disability
- Investigation of the anatomy or of a physiological process
- Control or support of conception
Software Based Medical Devices
If any software meets the definition of a Medical Device it is called as a software based medical device (SaMD). Software can mean any app, website, package, internet based service etc. It can be available on a watch, phone, tablet, laptop or other computer, or part of a hardware medical device.
Software Regulation
To understand whether your software is regulated, we need to understand the classification of a Medical Device. If the software does not meet the criteria of a Medical Device, the TGA does not regulate it. As per the regulations from February 2021, digital mental health tools will not be regulated if they are not intended for mental health management and meet certain criteria. The following are excluded from registration –
- The software follows established clinical practice guidelines;
- The guidelines are referenced and the reference to them is displayed in the tool; and
- The user can clearly view the guidelines.
To understand the latest regulations on SaMD’s, contact Morulaa to know more. You can contact us on admin@morulaa.com or through our website’s contact form.
