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TGA Guidance: Regulatory Changes for Software-Based Medical Devices

The Therapeutic Goods Administration (TGA) has released updated guidance (03 July, 2024) "Regulatory Changes for Software-Based Medical Devices". These changes are essential to keep pace with technological advancements and ensure that software-based medical devices are safe and effective for use.

The evolving landscape of software-based medical devices necessitates updated regulatory frameworks. These changes aim to provide clarity and ensure that these devices meet stringent safety and performance standards. The guidance applies to all software-based medical devices, including standalone software, software as a medical device (SaMD), and software integrated into medical devices.

The TGA has updated the classification rules for software-based medical devices. The new classifications better reflect the risks associated with the use of software in healthcare settings.

The definitions of software-based medical devices have been refined to include new categories and subcategories. This helps manufacturers and developers better understand the regulatory requirements specific to their products.

All new applications will need to meet the new classification rules from 25 February 2021, with a transition period ending 1 November 2024. If the regulatory changes result in the re-classification of a software-based medical device that is currently included in the ARTG, you can access transition arrangements that will allow you to continue supplying the device while you apply to include it in the ARTG under the new, higher classification.

The guidance provides comprehensive guidance for manufacturers on how to navigate the regulatory changes. This includes step-by-step instructions on how to prepare and submit documentation, conduct testing, and implement risk management processes.

The regulatory changes for software-based medical devices are crucial for maintaining high standards of safety and effectiveness in the face of rapid technological advancements. For more detailed information, refer to the full document: Regulatory Changes for Software-Based Medical Devices.


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