Jan 22, 2021
Australia’s Therapeutic Goods Administration (TGA) has published the Therapeutic Goods (Excluded Goods) Amendment (Software-Based Products) Determination 2021, which will become effective on February 25, 2021. This amends the Therapeutic Goods (Excluded Goods) Determination 2018 to identify software-based devices, including software as a medical device (SaMD), that are excluded from the TGA's medical device regulatory framework and should not be included in the Australian Register of Therapeutic Goods (ARTG). There are 15 software types identified here as excluded goods.
The software categories “carved out” from TGA regulation include the following:
Many of the software-based product descriptions include additional criteria that must be met if the products are to qualify for exemption from regulation, such as the requirement that the software is not intended to provide diagnosis, screening, treatment recommendations, etc.
To accompany the regulatory changes, the TGA has released the following four new draft guidance documents, which are accessible from the “Regulation of software based medical devices” guidance page:
These guidance documents are currently in draft form, and the TGA provides an email address to which feedback on any of them can be directed. Also available on the general guidance page are links to International Medical Device Regulators Forum (IMDRF) technical documents on SaMD and a literature review exploring the risks of harm from medical software.
Emergo by UL has also learned that the TGA has introduced an exemption for some clinical decision support software (CDSS), and the agency plans to soon publish guidance related to the exemption.
Finally, the TGA is working on an online classification tool that is meant to be released by February 25, 2021.
Australia’s Therapeutics Goods Administration published a regulatory amendment and corresponding guidance on the DoC requirement for low-risk IVDs.
The impact of the COVID-19 pandemic can be seen in the postponement of the new amendments, as well as in a special discount included in this fiscal year’s fee schedule.
The impact statement explores implementing a new regulatory scheme covering 3D-printed devices.
Version 2.2 of Australia’s Uniform Recall Procedure for Therapeutic Goods is now available online.