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Regulation of Software as a Medical Device

23 July 2020


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


16 July 2020

The TGA has conducted a rapid literature review of Actual and potential harm caused by medical software. See below for information.

Software is becoming increasingly important in medical devices. 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 TGA. This includes software and mobile 'apps' that meet the definition of a medical device.

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

The definition of Software as a Medical Device

A software product is considered to be a medical device if it fits the definition of a medical device in section 41BD of the Therapeutic Goods Act 1989.

A medical device is:

  1. any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following:
    1. diagnosis, prevention, monitoring, treatment or alleviation of disease;
    2. diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability;
    3. investigation, replacement or modification of the anatomy or of a physiological process;
    4. control of conception;

and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means.

Many types of software meet this definition and are therefore regulated. Some examples of SaMD include:

  • smart phone apps that calculate insulin doses based on a patient's blood glucose levels
  • X-ray image-processing software
  • software that uses information about a patient to make a diagnosis.

SaMD may be used with or in different computing platforms such as:

  • Computers*
  • Mobile phones*
  • Tablets*

*Note that for the SaMD examples the mobile phone, computer or tablet is not itself a medical device.

Health software apps that are not a medical device

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.

Apps that use accessories connected to, or embedded in, the platform

Some mobile apps require the use of physical accessories connected to, or embedded in, the computing platform. These can be sensors which plug into a port on the platform, or features provided in the platform such as speakers or a camera. This results in the combination of software, accessory and the computing platform becoming a medical device.

One example is a glucose meter that reads blood test strips and plugs into a smartphone to display and store the results. In this case, the combination of meter, smartphone and app, is a medical device. The app is regulated as part of the glucose meter device.

Software that is part of a device

Medical device software that is an integral part of a physical device (for example embedded software or firmware in a cardiac pacemaker) is considered to be part of the device and is not regulated separately.

Apps that control a medical device

Some mobile apps can control or adjust a medical device through Bluetooth or WiFi features. These apps are considered to be SaMD because they are accessories to the medical device. They are regulated at the same risk classification level as the medical device they control.

Software as a Medical Device (SaMD) regulation in Australia

The regulation of medical devices is risk-based. This means the level of scrutiny and oversight by the TGA will vary according to the level of risk the product represents to the patient or healthcare professional using it.

The current regulations do not adequately capture all SaMD under the rules for this risk classification. The potential risks arising from SaMD products can be low, medium or high depending on the intended purpose of the SaMD; however, at the present time many SaMD products are classified as low risk even though the potential risk for users may be higher. The TGA will soon be consulting on changes to the regulations to address this issue.

SaMD products must be included on the Australian Register of Therapeutic Goods (ARTG) before they are supplied in Australia.

The therapeutic goods legislation requires manufacturers of SaMD products (unless they are Class 1 - the lowest risk classification) to obtain Conformity Assessment certification to allow inclusion in the ARTG. All medical devices, irrespective of classification, are required to meet the Essential Principles for safety and performance.

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.

The TGA recognises the existing regulatory framework for medical devices in Australia may not be well structured to address the potential public health risks posed by SaMD products. Therefore, the TGA is currently reviewing the regulatory framework for SaMD in Australia, including considering where we can harmonise with the published IMDRF technical documents for SaMD.

Consultation on Scope of regulated software-based products

In February 2020, the TGA released a public consultation paper seeking feedback from stakeholders to further clarify the boundary for software-based products that, in law, are regulated under the Therapeutic Goods Act 1989, but could potentially be exempt or excluded (i.e. 'carved out') to ensure that industry sponsors and manufacturers are not subject to unnecessary regulatory burden.

To support this consultation, and 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 SaMD and other challenges associated with regulating digital medical devices. If you have questions about the regulation of SaMD or other digital medical technologies, please contact:

More information on SaMD will be coming soon. Note, software apps that are not medical devices are considered a consumer product and issues with these should be referred to the Australian Competition and Consumer Commission (ACCC).