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News & Trends - MedTech & Diagnostics

TGA seeks input from stakeholders on software-based medical devices

Health Industry Hub | April 22, 2020 |

MedTech News: 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.

The TGA is seeking feedback from stakeholders on proposed measures to clarify the boundary for software-based products that are captured under the regulatory framework for medical devices in Australia.

The measures also seek to ensure that sponsors and manufacturers of software-based products are not subject to unnecessary regulatory oversight. We are specifically seeking views on what type of software-based products could potentially be carved-out from regulation by the TGA.

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Feedback received from the previous consultation on Regulation of software, including Software as a Medical Device (SaMD) that closed on 31 March 2019, indicated that there was confusion over what was considered a medical device. Consequently, it was considered important to clarify this in consultation with stakeholders prior to the commencement of the regulatory changes.

Interested parties should respond by close of business Wednesday, 13 May 2020. All submissions will be placed on the TGA website unless marked confidential or indicated otherwise in the submission form.

Submissions will be reviewed by the TGA. Feedback from interested parties will be considered before seeking government’s approval of the 2020-21 fees and charges. A stakeholder feedback summary will be included in the TGA’s cost recovery implementation statement.

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