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Medical devices reforms: Medical device software regulation

Project status: in progress

7 April 2021

Project overview

New classification rules and amended essential principles clarify regulation of software-based medical devices.

The TGA has implemented reforms to the regulation of software-based medical devices, including software that functions as a medical device in its own right.

The essential principles for medical devices were amended to clarify existing requirements for software-based products. Regulations were introduced to classify software-based medical devices according to their potential to cause harm through the provision of incorrect information. The new classification rules have some similarities to the European Union Medical Devices Regulations (EU 2017 MDR).

These regulations commenced on 25 February 2021 for new applications for inclusion in the Australian Register of Therapeutic Goods (ARTG). Transitional arrangements will apply for medical devices included in the ARTG prior to 25 February 2021. Notifications for transitional arrangements for devices that may need to be reclassified can be made using the following form:

The clarification of the boundary for software-based products regulated as medical devices in Australia is important to ensure sponsors and manufacturers of software-based products are not subject to unnecessary regulatory oversight. From 25 February 2021, certain software-based medical devices have been carved-out (through either an exemption or exclusion) from the scope of the TGA regulation.

Guidance for industry

For general guidance on the regulation of software-based medical devices, including the changes mentioned above, see Regulation of software based medical devices.

If you have questions about the regulation of software-based medical devices, or other digital medical technologies that are not addressed in the guidance, please contact: digital.devices@tga.gov.au.

Note that software apps that are not medical devices are consumer products, and issues with these apps should be referred to the Australian Competition and Consumer Commission (ACCC).

Consultations

Consultation Status

Regulation of software, including Software as a Medical Device (SaMD)

Consultation closed 31 March 2019

Scope of Regulated Software based products

Consultation closed 13 May 2020

For more information see Consultations and reviews.

Keep up to date

Please contact the TGA at devices@health.gov.au if you have any queries or comments.

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For more information about other reforms visit Medical devices reforms.