The highly publicised investment by the US government in the Ellume COVID-19 home diagnostic testing device has re-focused attention on the med-tech space.

The integration of technology and medicine has always been a vexed issue due to –

  • reliability of diagnoses (everyone has a friend that’s been mis-diagnosed by Dr Google);
  • uncertainty surrounding the regulation of the technology; and
  • the use/mis-use of data that is generated by that technology.

It has also been problematic for lawmakers wanting to ensure low-risk devices are not over-regulated; and higher risk devices still go through the appropriate assessment processes before being made available for purchase.

It’s the job of the Therapeutic Goods Administration (TGA) to regulate this use of software in medical devices and approve those safe for use in Australia. On 25 February 2021 new regulations were introduced by the TGA that will impact on the manufacture or importation, and sale of regulated software.

what is regulated software?

Regulated software is software that falls within the definition of a medical device as determined by the TGA.  This includes:

  • software that functions as a medical device; and
  • software that controls medical devices.

Or put another way, software that has some kind of medical purpose; or works in combination with a medical device (e.g. a home COVID-19 diagnostic test kit that transmits data and makes a diagnosis based on software coding).

The importance of determining if the software is “regulated software” lies in the fact that regulated software cannot be sold or distributed in Australia unless it’s assessed by the TGA and is registered on the Australian Register of Therapeutic Goods (ARTG).

exclusions and exemptions

However, there are exclusions and exemptions, provided specific criteria are met:

  • excluded software is completely unregulated by the TGA and does not need to be registered on the ARTG. This includes consumer health products that do not deal with serious conditions or that provide specific treatment suggestions, enabling technology, health digitisation technology, data analytic tools not for clinical use, and laboratory information management systems. These software types generally do not provide diagnoses and can easily be used without a medical practitioner’s guidance. As such, it’s deemed they pose a low risk to the user and no assessment, or registration on the ARTG, is required.
  • Similarly, exempt software also doesn’t need to be registered on the ARTG. However, the TGA does retain some oversight over the manufacture or importation, and sale of the device.

For examples of exclusions and exemptions click here.

level of regulation: new classification of software-based medical devices (SaMD)

SaMD will now be categorised into four classes: Class I, Class IIa, Class IIb and Class III.

As a guiding principle, the classification depends on:

  • the severity of the disease, or medical condition, the subject of the SaMD; and
  • whether the software is for general use or medical practitioners.

E.g. software intended to diagnose or screen for diseases which may lead to the death of a person are classified as Class III, while software intended to provide information to a medical professional on a disease which has no serious health implications and does not pose a risk to public health will be Class I.

the practical effect of your SaMD class category

The TGA applies different assessment procedures to the SaMD depending on the class it’s categorised in: the higher the class, the more onerous the assessment prior to being listed on the ARTG.

Additionally, lower class products can get through the assessment process significantly faster; and if you can establish that an exemption or exclusion applies, then assessment isn’t required at all! Accordingly, if your priority is getting your product on the market as soon as possible, it may be worth tweaking your product to make sure you fall within a lower class, exemption or exclusion.

when do these new classifications apply, and what do you need to do?

The new classification rules commence on 25 February 2021 for all applications for SaMD seeking inclusion on the ARTG on or after this date.

For all SaMD included in the ARTG, or those SaMD applications lodged, prior to 25 February 2021, the new classification rules will apply from 1 November 2024.

However, if your SaMD has been reclassified to a higher classification, to be eligible to continue to supply your SaMD, you must notify the TGA that your SaMD has been reclassified –

  • by 25 August 2021 for an SaMD included in the ARTG; and
  • within 2 months of the date your SaMD is included in the ARTG, forSaMD applications lodged prior to 25 February 2021.

If you don’t notify the TGA of your SaMD before the applicable date, you must cease supplying the SaMD from this date.

Once the notification has been done, you will then have until 1 November 2024 to:

  • obtain the appropriate evidence of conformity assessment; and
  • submit an application for inclusion in the ARTG under the new classification rules.

Again, if you don’t submit your application by 1 November 2024, you must cease supply on or before this date and cancel your inclusion.

essential principles

As a part of the process for inclusion in the ARTG, manufacturers must demonstrate compliance with the Essential Principles for their SaMD.  A checklist for the minimum standards can be found here.

On 25 February 2021, there will also be changes to the Essential Principles with which you must comply.

what are the changes to the essential principles?

There are three updates to the Essential Principles:

  1. introduction of new principle, 13B, which requires software to make the version and build number available to users in English;
  2. an amendment to principle 12.1, which requires software to use best practice and state of the art cybersecurity, data management and the development, production & maintenance of software; and
  3. principle 13.2(3) is updated to allow information about the SaMD to be made available in an electronic format or in a physical brochure.

when do these new essential principles apply?

  • All SaMD need to comply with 12.1 and 13.2(3) from 25 February 2021.
  • All SaMD lodged after 25 February 2021 will need to comply with 13B before they can be included in the ARTG.
  • Any SaMD already included in the ARTG, or if lodged before 25 February 2021, have until 1 November 2024 to comply with 13B.