In response to rapid technological innovation and software production globally, Australia’s Therapeutic Goods Administration (TGA) has increased its regulation of software-based medical devices. Importantly, the grace period for changes to the regulation of software medical devices (including software as a medical device – SaMD) which came into effect on 25 February 2021 will end on 1 November 2024.
These changes aim to ensure patient safety by regulating all software products meeting the definition of a medical device under the Therapeutic Goods Act 1989 (TG Act). If software is a medical device, it must be included and correctly classified on the Australian Register of Therapeutic Goods (ARTG) before it can be legally supplied in Australia.
What are the reforms relevant to software?
Definition of Medical Device
Software products that are medical devices must be included on the ARTG, unless they are excluded or exempt, before they can be legally supplied in Australia.
As changed on 25 February 2021, a medical device is defined in section 41BD of the TG Act. The definition is broad and captures many kinds of products.
| Category | Criteria |
| Medical devices – general | A medical device is any instrument, apparatus, appliance, software, implant, reagent, material or other article intended to be used for human beings for one or more of the following purposes (subsection 41BD(1)(a)):
If a product satisfies the above, it is a medical device if it does not achieve its ‘principal intended action’ in or on the human body by pharmacological, immunological or metabolic means, but it may be assisted in its function by those means (subsection 41BD(1)(a)). |
| Accessories | An accessory for a product that falls under the above category is a medical device (subsection 41BD(1)(b)). |
| Medical device by TGA notice | A medical device may also be specified by the TGA through notice published in the Commonwealth Government Gazette or on the TGA’s website (subsection 41BD(2A)). |
| Medical device by legislative instrument | The TGA may specify a particular product or class of product to be a medical device by legislative instrument (subsections 41BD(2B) and 41BD(3)). |
| Systems and procedure packs | A medical device can be a system or procedure pack (subsection 41BD(1)(c)). |
Software (including mobile apps) may be classified as a medical device if it falls into any of the above categories, unless explicitly excluded or exempted.
Excluded and Exempted Products
Currently, there are 15 exclusions and one exemption for specific kinds of software products which would otherwise fall under the definition of a medical device.
Excluded products are not subject to any TGA regulatory requirements and therefore do not need to be included on the ARTG. These exclusions are provided for in Schedule 1 of the Therapeutic Goods (Excluded Goods) Determination 2018 (Cth). Broadly, the categories of excluded software products under Schedule 1 are:
- Consumer health products (Exclusion 14A);
- Digital mental health tools (Exclusion 14E);
- Enabling technology for telehealth, or supporting healthcare delivery (Exclusion 14F);
- Middleware (Exclusion 14K);
- Digitisation of paper-based data or other published clinical rules (Exclusion 14L);
- Population based analytics (Exclusion 14N); and
- Laboratory information management systems and laboratory information systems (Exclusion 14O).
In addition to this, the TGA issued an exemption for certain clinical decision support system (CDSS) software in February 2021 (Schedule 4, Part 2 of the Therapeutic Goods (Medical Devices) Regulations 2002 (Cth) (Regulations). Goods that are exempt are still regulated by the TGA, including in terms of advertising, adverse events and notification requirements, but they do not need to be included on the ARTG.
How do I know if my software is regulated?
The steps of inquiry to determine whether software is regulated as a medical device under the amendments can be summarised as follows:
- Is your product ‘software’ (noting that this includes apps)?
If the answer is yes, proceed to next question.
- Is its purpose likely to be medical?
Under the Regulations, an ‘intended purpose’ of a medical device is defined as what the manufacturer intended the goods to be used for, as stated in:
- the information provided with the device; or
- the instructions for use of the device;
- any advertising material applying to the device; or
- any technical documentation describing the mechanism of action of the device.
If the intended purpose includes one or more of the following, it does have a medical purpose (then proceed to question 3):
- diagnosis, monitoring, prediction, prognosis, treatment or alleviation of disease, injury or disability;
- prevention of disease;
- compensation for an injury or disability;
- investigation, replacement or modification of the anatomy or of a physiological or pathological process or state; or
- control of support of conception.
If the answer is no, does your product work in combination with a medical device? If it does not, it is not a medical device. If it does, does your product enable or assist with the function of that medical device? If the answer is no, it is not a medical device. Alternatively, if the answer is yes, your product is an accessory and may be regulated as a medical device.
- Is it excluded?
If your product may be excluded if it falls under one of the following exclusion categories:
- consumer health life-cycle prevention, management and follow up;
- enabling technology for telehealth, remote diagnosis, and healthcare facility management;
- digital mental health tools;
- digitisation of paper-based other published clinical rules or data;
- population-based analytics; or
- laboratory information management systems and laboratory information systems.
Reference needs to be made to Schedule 1 of the Therapeutic Goods (Excluded Goods) Determination 2018 (Cth) to confirm the exclusion.
If your product is not excluded, proceed to the next question.
- Does it work directly with data obtained in vitro?
If the answer is yes, then it is an in vitro diagnostic (IVD) medical device, and therefore subject to TGA regulation.
If the answer is no, proceed to the next question.
- Does it support clinical decisions?
The TGA considers clinical decision support software (CDSS) to be software that performs a broad range of functions that facilitate, support and enable clinical practice. An example is software intended to analyse an x-ray image to assist a radiologist in identifying anomalies.
If the answer is yes, proceed to the next question.
- Is the CDSS exempt?
There are three criteria for CDSS which meets the medical device definition being exempt from the requirement to be entered on the ARTG (Regulations, Schedule 4, Part 2, section 2.15):
- the software is not intended to directly process or analyse a medical image or a signal from another medical device (including an IVD medical device);
- the software is intended only for the purpose of providing or supporting a recommendation to a health professional about prevention, diagnosis, curing or alleviating a disease, ailment, defect or injury; and
- the software is not intended to replace the clinical judgement of a health care professional to make a clinical diagnosis or treatment decision regarding an individual patient.
If all three criteria are met, it is an exempt medical device. Note that this exemption does not apply to CDSS which have multiple functions that do not meet the above requirements.
If the criteria are not satisfied, your product is a medical device.
Classification Rules
There are new classification rules applying to programmed and programmable medical devices, and medical devices that are software. The new rules will largely apply to software-based medical devices whose function or purpose is in any of the following:
- diagnosis or screening;
- monitoring;
- specification or recommendation of a treatment or intervention; or
- information as therapy.
Devices with one or more of the above functions or purposes may need to be re-classified under the new rules. Medical devices are classified according to the medical device classification rules in Schedule 2 of the Regulations.
All applications for inclusion of software-based medical devices in the ARTG made after 1 November 2024 must meet the new classification rules. By that date, the transition period will end for sponsors of eligible medical devices already included in the ARTG or included in the ARTG because of an application lodged before 25 February 2021.
Essential Principles
The TGA has developed Essential Principles (Part 2 and Schedule 1 of the Regulations) that all medical device manufacturers or sponsors in Australia must comply with. In the reforms, two essential principles were amended and one was added.
| Essential Principle | Amendment / Insertion |
| Essential Principle 12.1 | Amended to clarify already existing requirements for cyber security, data and information management, and requirements related to development, production, and maintenance. |
| Essential Principle 13.2(3) | Amended to enable the information that must be provided with a medical device that is software to be provided electronically as opposed to in a leaflet or brochure. |
| Essential Principle 13B | Inserted and mandates the version and build number of software devices be accessible and identifiable by users of medical device that is software. This information must also be in English. |
Conclusion
With the reforms coming into full effect later this year, businesses need to be vigilant in ensuring that their software and apps which can be considered medical devices are complying with all the TGA’s regulatory requirements. Please contact us if you would like our assistance.
This article was written by Helen Kavadias, Partner and Kirsten Schreuder, Solicitor.
