
Transition Plan and Regulatory Changes for Software as Medical Devices
In our November 2020 blog post, we communicated the changes regarding the implementation dates and the criteria for Software as a Medical Device regulations as amended in the Therapeutic Goods...

TGA guidance for SaMD Regulatory “Carve Out”
Following a public consultation on the Regulation of software, including Software as a Medical Device (SaMD) in early 2019, the TGA introduced several regulatory changes, including: new classification rules for...