Software as a medical device – TGA excluded products

 The Therapeutic Goods Act 1989 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. 

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.

Examples of excluded products:

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 products 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. 

A list of excluded products which includes certain softwares, such as: 

1. software that is:

• 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;

3. software that is intended by its manufacturer to be used for the sole purpose of storing or transmitting patient images.

Reference: https://www.tga.gov.au/how-we-regulate/manufacturing/medical-devices/manufacturer-guidance-specific-types-medical-devices/regulation-software-based-medical-devices

https://www.tga.gov.au/resources/resource/guidance/examples-regulated-and-unregulated-software-excluded-software-based-medical-devices