Australia TGA published a summary of regulatory changes to the regulation of software-based medical devices (including software as a medical device – SaMD) that take effect from 25 February 2021. The summary also outlines transition arrangements available for devices that may need to be reclassified or that qualify for an exemption or exclusion from the Therapeutic Goods (Medical Devices) Regulations 2002.
The changes include:
1. Clarifying the boundary of regulated software products (including ‘carve outs’)
The clarification of the boundary for software-based products regulated as medical devices in Australia is important to ensure sponsors and manufacturers of software-based products are not subject to unnecessary regulatory oversight.
2. Introducing new classification rules for programmed and programmable medical devices, and medical devices that are software. This includes all software-based medical devices.
There are 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
• Provides therapy through the provision of information
3. Providing updates to the essential principles to more clearly express the requirements for software-based medical devices.
Please refer to the link below for further information
Link: Regulatory changes for software based medical devices
https://www.tga.gov.au/resource/regulatory-changes-software-based-medical-devices