Can software used for medical purposes be regulated by the TGA?

Speaking at a recent Flinders University Medical Device Partnering Program (‘MDPP’) event, head of the Therapeutic Goods Administration (‘TGA’) John Skerritt gave an insight into the TGA’s view of the rapidly developing area of ‘software as a medical device’.

The TGA regulates therapeutic goods in Australia including prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products.  According to Mr Skerritt, in the TGA’s view, software as a medical device can be adequately regulated by the current TGA legislative regime.  Despite the rapid advancement of technology, we tend to agree with him.

What is a ‘medical device’?

In the case of software as a medical device, the legislative definition of ‘medical device’ is what pulls a particular product under the ambit of TGA regulation (or not).

The Therapeutic Goods Act 1989 (‘Act’) defines a ‘medical device’ as:

‘Any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following:

  1. diagnosis, prevention, monitoring, treatment or alleviation of a disease;
  2. diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability;
  3. investigation, replacement or modification of the anatomy or of a physiological process;
  4. control of conception;

and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means.’

What about medical apps?

One big area of change is medical apps (software applications generally designed specifically for mobile devices such as smartphones) and in particular, diagnostic or monitoring apps that for example, measure the blood glucose levels of a patient.  In our view such an app is a medical device as it is material or some other article including the software necessary for its proper application intended by the supplier to be used on human beings for the purpose of diagnosis or monitoring of a disease (diabetes).

The TGA has made it clear on their website that they do not consider the smartphone itself to be a medical device.  Skerritt also made it clear that they do not intend to catch ‘informational’ apps such as medical clinical guidelines that would traditionally have been published on paper but are now being delivered via apps.

However, just because they have smartphone apps covered does not mean that the TGA’s definition of medical device will stay ahead of the curve for long. And they are not the only ones that have to worry about it. Internationally, other regulatory agencies such as America’s FDA are closely monitoring developments in the medical software arena. The FDA’s slides on the issue can be found here.

Has the TGA’s view been tested?

It is also worth remembering that the TGA’s view of the law is only one interpretation; although its view gives guidance on what is and is not caught by the Act, in order for that view to be confirmed in any particular case it would have to be the subject of a court judgement.

Adequate regulation of the medical technology sector is important from a risk perspective.  It is good to see the TGA taking a proactive approach to keeping abreast of developments. That said, if you have an issue with a decision made by the TGA in relation to your product or otherwise, there are appeal channels available.

Kain’s Health and Medical Team

The Health and Medical team at Kain C+C includes lawyers experienced in the allied health, medtech and biotech sectors and in administrative appeals.

This article is provided for your information only and is not legal advice.  If you have any concerns as to whether or not your product is caught by the TGA regime, you should seek legal advice on your particular circumstances.