There Are Big Changes Coming In Medical Software Regulation From The TGA. We Need To Grasp What It Means!

These two articles appeared last week:

First:

TGA announces major changes to regulation of software-based medical devices

Corrs Chambers Westgarth

The Therapeutic Goods Administration (TGA) has announced major changes to how software-based medical devices will be regulated under the Therapeutic Goods Act 1989 (Cth) (Therapeutic Goods Act).

There are three types of software-based medical devices affected by the changes:

1. Devices referred to as ‘programmed or programmable medical devices’.
2. Software that is a medical device.
3. Clinical decision support software (CDSS).

The changes will commence on 25 February 2021 and include:

• the exclusion and exemption of certain software-based medical devices from regulation under the medical device regime under the Therapeutic Goods Act;
• the introduction of new classification rules for software-based medical devices (these will impact both existing entries on the Australian Register of Therapeutic Goods (ARTG) and new entries for software-based medical devices); and
• the amendment of existing essential principles, and the introduction of new essential principles, for software-based medical devices.

In addition to changing how software-based medical devices will be regulated going forward, the changes will have an immediate impact on software-based medical devices already entered on the ARTG and may require sponsors and manufacturers to take immediate steps. The TGA has also issued guidance about the impending changes.

In this article, we provide a brief overview of how software-based medical devices are regulated in Australia, a summary of the key changes, and the suggested next steps for sponsors and manufacturers.

Background

The Therapeutic Goods Act aims to ensure that all medicines, biologicals and medical devices supplied in Australia are safe and achieve their intended therapeutic purpose. Regulated goods must comply with strict requirements, including being registered on the ARTG, complying with advertising conditions, and being subject to appropriate oversight with respect to safety and performance.

A software-based product can become regulated under the Therapeutic Goods Act as a ‘medical device’. A medical device is ‘any instrument, apparatus, appliance, software, implant, reagent, material or other article’ which is intended to be used for a therapeutic purpose (including to diagnose, prevent, monitor or treat a disease, injury or disability), but which does not achieve its principal intended action by pharmacological, immunological or metabolic means.[1]

This definition can lead to a broad range of devices becoming subject to the Therapeutic Goods Act, including low risk ‘lifestyle’ or ‘consumer’ products, mobile apps and software. Given this, stakeholders in the medtech and digital health sectors have for some time been calling for an overhaul of the Australian medical device regulations to software-based medical devices.

Pages more here:

https://www.lexology.com/library/detail.aspx?g=4e60f71d-cd99-47ce-8099-3b9c0cc370aa

and second here:

Upcoming changes to the regulation of software-based medical devices in Australia

DLA Piper

There was an unprecedented uptake of digital technology in 2020 in the healthcare sector, and 2021 is expected to be no different. In creating these technologies for the healthcare sector, developers should ensure that all applicable regulatory requirements are complied with.

In Australia, software may be regulated by the Therapeutic Goods Administration (TGA) as a medical device if it falls within the definition of “medical device” as set out in section 41BD of the Therapeutic Goods Act 1989 (Cth). Further, from 25 February 2021, changes to the Therapeutic Goods (Medical Devices) Regulations 2002 (Cth) will come into effect which seek to clarify some existing requirements around the regulation of software-based medical devices, and introduce new requirements. We provide an update about these changes below.

Software-Based Medical Devices

The definition of “medical device” includes software that is intended to be supplied to be used by a person for one or more of the following purposes:

• the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease;
• the diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability;
• the investigation, replacement or modification of the anatomy or of a physiological or pathological process or state;
• the control or support of conception.

Based on a strict reading of this definition, a large number of software-based products may be captured and regulated as medical devices.

In order to clarify the boundaries for the regulation of software-based products as medical devices in Australia, to ensure that Australia is aligned with international regulatory frameworks where appropriate, and to reduce or remove unnecessary regulatory burden, including by not regulating products where there is no significant risk to safety, from 25 February 2021, certain software-based medical devices will be either exempted or excluded from the scope of regulation by the TGA.

Lots more here:

https://www.lexology.com/library/detail.aspx?g=5117ea11-15f0-4f34-bfb5-a341247bb829

Not being a lawyer I find it rather difficult to understand the full scope and depth of what the TGA is about here and just what the practical implications are. Any guidance would be welcome to us all I suspect!

David.