Proposed clarification of how Clinical Decision Support System (CDSS) software is regulated

Overview

The Therapeutic Goods Administration (TGA), as part of the Australian Government Department of Health and Aged Care, regulates therapeutic goods including medicines, medical devices, and biologicals to help Australians stay healthy and safe.

Ongoing reforms are undertaken by the TGA to ensure the regulatory oversight of all therapeutic goods remains appropriate. The objective of the reforms is to ensure the sustainability of the Australian regulatory system for therapeutic goods while delivering safe and timely access to the products the TGA regulates.

In February 2021, the TGA introduced clarifications to the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations) for software-based medical devices. The changes were prompted by the government’s request to improve the regulation of digital medical devices, and specifically to:

• consider measures that would clarify the boundary for software-based products that are captured under the regulatory framework for medical devices in Australia; and
• ensure that sponsors and manufacturers of software-based products are not subject to unnecessary regulatory oversight.

In considering what could potentially be carved out from regulation, the following principles were followed:

• align internationally where appropriate
• work to reduce or remove unnecessary regulatory burden,

• by not regulating products where there is minimal-to-no risk to safety (a no-harm principle)
• by not regulating twice (that is, where suitable frameworks for product or system oversight are already in place) including products recognised as clinical decision support system (CDSS) software.

Since then, stakeholders, including industry, have raised questions and sought additional clarification on what CDSS are, how the conditional exemption applies to certain CDSS, and what regulatory obligations need to be met to supply a CDSS in Australia.

Why your views matter

This consultation paper is intended to seek feedback on what additional clarifications and information or guidance are required to address these concerns.