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Regulation of software based medical devices

18 February 2021

Update

23 July 2020

The Governor-General in Council has made regulations which delay the commencement of a number of medical device reforms in Australia. This delay reflects the challenges identified by the medical devices industry and healthcare professionals to redirect their efforts to regulatory changes as they have focussed on the COVID-19 crisis.

The delay will allow additional time for the Therapeutic Goods Administration (the TGA) to further consult with the medical device industry and health care professionals on guidance material and implementation details relating to the reforms.

You can find out more information at: Delays to the commencement of certain medical device regulatory changes and Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019.

Software is becoming increasingly important in medical devices and digital adoption more broadly. In addition, it is becoming more and more important as a medical device in its own right.

Medical devices are regulated in Australia by the Therapeutic Goods Administration (TGA). Software (including mobile apps) is a medical device if it fits the definition of a medical device in section 41BD of the Therapeutic Goods Act 1989, unless otherwise excluded.

Many mobile apps are simply sources of information, or tools to manage a healthy lifestyle. The TGA does not regulate health and lifestyle apps and software that do not meet the definition of a medical device.

The following guidance is intended to provide information on the regulation that applies to software and apps which meet the legislated definition of a medical device in Australia.

Guidance

The purpose of this guidance is to help manufacturers and sponsors understand how the TGA interprets requirements, and thus indicate how manufacturers and sponsors can comply.

This is a guide only, and manufacturers and sponsors are encouraged to familiarise themselves with the legislative and regulatory requirements in Australia, and if necessary, to seek professional advice. It is the responsibility of each manufacturer or sponsor to understand and comply with these requirements.

These documents are currently in draft and updates and clarifications will be included as required. Feedback on the guidance is always welcome, please send any comments to digital.devices@tga.gov.au.

If you are new to TGA regulation, this guidance steers developers and users of software to decide which software and apps are medical devices, and which are general health management and fitness software:

This guidance summarises the regulatory approach of the TGA for 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 following guidance provides a summary of changes to the regulation of software based medical devices (including software as a medical device - SaMD) that take effect from 25 February 2021. It outlines transition arrangements available for devices that may need to be reclassified or that qualify for an exemption or exclusion from the Therapeutic Goods (Medical Devices) Regulations 2002.

Detailed guidance on the exemption for clinical decision support software:

Cybersecurity is an important consideration for medical devices and IVD medical devices (IVDs). We have produced guidance specific to industry as well as guidance and information specific to users, including consumers and health professionals:

International regulatory activities

The TGA is a founding member of the International Medical Device Regulators Forum (IMDRF), a group of medical device regulators from around the world who meet regularly to address current challenges in regulating medical devices, and to accelerate harmonisation of regulation.

In 2013, the IMDRF established working group dedicated to Software as Medical Device, and they have been working on the challenges associated with it. As an active member of the working group, the TGA contributed to the four published technical documents relating to the regulation of SaMD:

  • Software as a Medical Device (SaMD): Key Definitions
  • Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations
  • Software as a Medical Device (SaMD): Application of Quality Management System
  • Software as a Medical Device (SaMD): Clinical Evaluation

These documents were consulted internationally before being finalised and are available on the IMDRF Documents webpage (Technical documents section). Together, they cover the definition of Software as a Medical Device, as well as how existing regulatory tools such as quality management and clinical evidence can be applied to it.

Risks of harm from software

To understand the actual and possible risks of harm from software, a rapid literature review was undertaken. The review considered articles and papers published over the last seven years that specifically addressed safety and efficacy, including mobile apps and medical software more broadly. The papers were identified using MEDLINE, Pubmed and Google Scholar.

Many of the studies cited in the review relate specifically to challenges with SaMD, and software controlling medical devices, however some additional reports of safety and performance issues with medical software have also been included for context.

The literature review can be found at Actual and potential harm caused by medical software.

Further information

The TGA has people dedicated to software and other challenges associated with regulating digital medical devices. If you have questions about the regulation of software or other digital medical technologies, please contact: digital.devices@tga.gov.au.

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