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. The changes took effect from February 25, 2021, and all applications for the inclusion of software-based medical devices in the ARTG made after this date must meet the amended classification rules.
Amendments to the Therapeutic Goods Regulations 2002 (Regulations) include: (1) clarifying the boundary of regulated software products, (2) introducing new classification rules for software-based medical devices (which are intended for i. Providing a diagnosis or screens for a disease or condition; ii. Monitoring the state or progression of a disease or condition; iii. Specifying or recommending a treatment or intervention; And iv., providing therapy through the provision of information), and (3) providing updates to the essential principles to more clearly specify the requirements for software-based medical devices. The transition period (ending 1 November 2024) applies to sponsors of eligible medical devices already included in the ARTG, or included in the ARTG because of an application lodged before 25 February 2021. In addition, many software-based products’ descriptions include additional criteria that must be met if the products are to qualify for exemption from regulation. To respond to the regulatory changes, the TGA has released the following four steps with new draft guidance documents, which are accessible from the TGA’s website: (1) Is my software regulated? (2) How the TGA regulates software-based medical devices; (3) Regulatory changes for software-based medical devices, (4) Examples of regulated and unregulated (excluded) software-based medical devices. The TGA provides an E-mail address to which feedback on any of them can be suggested. The TGA has introduced an exemption for certain Clinical Decision Support Software, and published the guidance related to the exemption as a draft version now without implementation.