Australia - Re-classification of software based medical devices

Australia TGA has announced that in early 2021, the new regulations for software-based medical devices went into force, resulting in a categorization level change for some devices. These new categorization guidelines apply to all new applications for inclusion of software-based medical devices in the Australian Register of Therapeutic Goods (ARTG). However, there is a transition period for software that is already on the ARTG. To be eligible for the transition period, you must notify the TGA by 25 August 2021.

The new classification requirements for software-based medical devices that

• provide a diagnosis or screen 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

• provide therapy through the provision of information.

Sources:

Re-classification of software based medical devices

Regulatory changes for software based medical devices

Contact us at info@arqon.com for more info