Under the microscope: TGA regulation of “Software as a Medical Device”

By Hannah Fas / 09 August 2023
6 min.

The Therapeutic Goods Act 1989 (Cth) (the Act) sets out the criteria for the inclusion of therapeutic goods in the Australian Register of Therapeutic Goods (ARTG), the process for securing authorisation from the Therapeutic Goods Administration (TGA), and requirements for advertising, labelling and product appearance. 

HopgoodGanim Lawyers’ Intellectual Property, Technology and Cyber Security team includes legal professionals with experience in the practical workings of the TGA. In this article, we dissect the types of goods that might be excluded, with a particular focus on “software as a medical device”, further exploring this topic after our coverage TGA turns up the heat on advertising requirements and The Therapeutic Goods Administration at a glance

Medical devices that incorporate or are comprised of software (including software as a medical device), or software that relies on particular hardware to function as intended, are regulated in Australia by the TGA. Software (including mobile apps and wearable devices) is a medical device if it fits within the definition of a medical device in the Act, unless otherwise excluded.

Dissecting excluded goods

Some products deemed “low-risk” are excluded from the TGA’s regulatory framework – this means they are not regulated by the TGA, and are not included in the ARTG. 

Generally, excluded goods have the following functions: 

  • consumer health products – prevention, management and follow up devices that do not provide specific treatment or treatment suggestions; 
  • enabling technology intended to support telehealth, remote diagnosis, healthcare or dispensing; 
  • digitisation of paper based or other published clinical rules or data including simple dose calculators and electronic patient records; 
  • population based analytics that do not drive outcomes for individuals; or 
  • laboratory information management systems – systems to automate workflows, integrate instruments, manage orders and samples and associated information. 

Section 7AA of the Act provides that the Health Minister may, by legislative instrument, determine that specified goods are excluded goods for the purposes of the Act. The Therapeutic Goods (Excluded Goods) Determination 2018 (the Determination) constitutes such a determination. Specifically, Schedule 1 of the Determination contains a list of excluded goods, which includes certain software goods, such as: 

1. software that is:1

  • intended by its manufacturer to be used by a consumer for the self-management of an existing disease, condition, ailment or defect that is not a serious disease or serious condition, ailment or defect; and
  • not intended by its manufacturer to be used:
  • in clinical practice; or
  • in relation to a serious disease or serious condition, ailment or defect; or
  • for the purpose of diagnosis, treatment, or making a specific recommendation or decision about the treatment, of a disease, condition, ailment or defect that is not a serious disease or serious condition, ailment or defect; and 

2. software that is a digital mental health tool (including a cognitive behaviour therapy tool) based on established clinical practice guidelines that are referenced and displayed in the software in a manner that is reviewable by the user;2 and
3. software that is intended by its manufacturer to be used for the sole purpose of storing or transmitting patient images.

Other legal elements to consider

Of course, other legal considerations will affect how a software product is used, commercialised, licensed, and promoted. The below paragraphs are examples only.

Australian consumer law

The Australian Consumer Law, set out in Schedule 2 of the Competition and Consumer Act 2010 (Cth) (ACL):

  • prohibits a person from: engaging in conduct, in trade or commerce, that is misleading or deceptive or is likely to mislead or deceive;3 and in connection with the supply or possible supply of goods or services or in connection with the promotion by any means of the supply or use of goods or services, making a false or misleading representation that:
  • goods or services have a sponsorship, approval, performance characteristic, accessory, use or benefit that they do not have;4 or
  • the person making the representation has a sponsorship, approval or affiliation that it does not have;5 
  • entitles consumers to certain guarantees in respect of goods and services they have been supplied with if the supply occurred in trade or commerce. Specifically, in respect of goods, consumers are entitled to a guarantee that, relevantly:6 
    • the goods will be of acceptable quality, and fit for any disclosed purpose or purpose for which the supplier represents they are reasonably fit;
    • the goods will match their description; and
    • goods will comply with any express warranty given by the manufacturer or supplier.
  • as for services, consumers are entitled to a guarantee that, relevantly, services provided to them by a supplier:7 
  • will be provided with due care and skill; and
  • will be fit for the particular purpose for which the services are being acquired by the consumer, as expressly or impliedly made known to the supplier.

Retention of health records

If your software handles personal information, privacy considerations will be paramount. In particular, federal and state-based legislation imposes various obligations around secure storage, retention and destruction of personal information including health records:

  • at a federal level – the Privacy Act 1988 (Cth) and Australian Privacy Principles; and
  • in Queensland – the Public Records Act 2002 (Qld), which is accompanied by the General Retention and Disposal Schedule for Administrative Records and the Health Sector (Clinical Records) Retention and Disposal Schedule.

How HopgoodGanim can assist

HopgoodGanim Lawyers’ Intellectual Property, Technology and Cyber Security team includes legal professionals with experience in the practical workings of the TGA.  

We can assist individuals and companies involved in the manufacture, advertising and supply of therapeutic goods with matters including:

  • assistance with determining whether your product is a “therapeutic good” and therefore subject to the TGA;
  • liaising with regulatory consultants in Australia and overseas, to deliver comprehensive support in major international markets;
  • preparation or review of contracts for research and development, manufacturing, clinical trials, resale and distribution arrangements;
  • strategic licensing and commercialisation of your therapeutic good; and
  • seeking patent and registered design protection for your therapeutic good, and trade mark protection for your brand;
  • preparing agreements with brand ambassadors; and
  • reviewing advertising collateral for compliance with Therapeutic Goods Act, Therapeutic Goods Advertising Code and Australian Consumer Law.

For more information or discussion, please contact HopgoodGanim Lawyers’ Intellectual Property, Technology and Cyber Security team

A special thanks to Siobhan Beckett and Matthew Stark for their assistance in putting this article together.

2. 14E
3. ACL section 18.
4. Ibid, section 29(1)(g).
5. Ibid, section 29(1)(h).
6. ACL sections 51 – 56, 59.
7. Ibid, sections 60 – 61.

09 August 2023
Key Contacts
Hannah Fas
Senior Associate
Hannah is a Senior Associate in our Intellectual Property, Technology and Cyber Security team.

What’s new

Be the first to receive our content

Subscribe today