AusBiotech is seeking comment from affected members on a TGA consultation on proposed measures to clarify the boundary for software-based products that are captured under the regulatory framework for medical devices in Australia.
Medical device regulations are currently being reformed, including a potential exemption or exclusion of certain regulated software as a medical device (SaMD), such as smartphone apps that may be used to diagnose and monitor disease. The reforms are also in line with similar changes introduced by regulators internationally, including in the EU.
The measures also seek to ensure that sponsors and manufacturers of software-based products are not subject to unnecessary regulatory burden, for example in cases where products present lower risk to safety or where products may already be subject to suitable oversight under other regulatory frameworks. Specifically, views on what type of software-based products could potentially be carved-out from regulation by the TGA are sought.
Advances in computing technology has given rise to a rapidly evolving environment that includes many new medical device software products, and many health-based products which are crossing and/or blending traditional boundaries of therapeutic product definitions. As a consequence, the boundary for regulated software products is becoming more difficult to identify, a situation that has caused therapeutic goods regulators around the world to consider, or to implement, changes to their frameworks to address uncertainty.
In early 2019, the TGA conducted a public consultation on the Regulation of software, including Software as a Medical Device (SaMD). Proposals for change included:
- new classification rules for medical device software-based products (not including in vitro diagnostic medical device software); and
- changes to the essential principles for safety and performance of software-based medical devices to improve the clarity of requirements.
Regulatory changes based on government decisions following this consultation were made on 12 December 2019 to incorporate the changes mentioned above. The majority of the new requirements will be effective from 25 August 2020 but will include a four-year transition period for eligible manufacturers and sponsors (until 1 November 2024). A summary of the changes can be found on the TGA website here. Further detailed guidance is to follow and to some extent will be informed by this consultation process.