The Australian Therapeutic Goods Administration (TGA) has implemented reforms to the regulation of software-based medical devices, including software that functions as a medical device in its own right (i.e. it is not attached to any physical medical device).  

Amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 (Regulations) include:

• clarifying the boundary of regulated software products;
• introducing new classification rules for software based medical devices that:
  • provide a diagnosis or screens for a disease or condition;
  • monitor the state or progression of a disease or condition, or the parameters of a person with a disease or condition;
  • specify or recommend a treatment or intervention; or
  • provide therapy through the provision of information; and
• providing updates to the essential principles to more clearly express the requirements for software-based medical devices.

The new classification rules will subject these software-based medical devices to more stringent pre-market requirements (such as external conformity assessments) depending on the function of the device, risk of harm and whether the user is a health professional or patient. Software-based medical devices are classified from Class I (low risk) to Class III (high risk).

The changes came into effect from 25 February 2021 and all applications for inclusion of software-based medical devices in the ARTG made after this date must meet the amended classification rules.

For medical devices that are already included in the ARTG (including applications that were lodged before 25 February 2021) and need to be included at a higher classification as a result of the amendments, transition arrangements apply with the transition period ending 1 November 2024. Sponsors must notify the TGA that they have an eligible inclusion by 25 August 2021 or within 2 months of the start date of the ARTG entry, whichever is the later date. A sponsor will not be eligible to continue supplying their medical device if they fail to notify the TGA.

More information can be found in the TGA's publication on the regulatory changes.