Medical devices reforms: software regulation

Project overview

We reformed the regulation of software-based medical devices, including software that functions as a medical device.

The Essential Principles for medical devices were amended to clarify existing requirements for software-based products.

Regulations were introduced to classify software-based medical devices according to their potential to cause harm through the provision of incorrect information.

The new classification rules have some similarities to the European Union Medical Devices Regulations (EU 2017 MDR).

These regulations commenced on 25 February 2021 for new applications for inclusion in the Australian Register of Therapeutic Goods (ARTG).

The clarification of the boundary for software-based products regulated as medical devices in Australia is important to ensure sponsors and manufacturers of software-based products are not subject to unnecessary regulatory oversight.

From 25 February 2021, certain software-based medical devices have been carved-out (through either an exemption or exclusion) from the scope of the TGA regulation.

The Australian Competition and Consumer Commission (ACC) has oversight of consumer software apps that are not regulation medical devices.

Consultations

More information

• Regulation of software based medical devices
• Regulatory changes for software based medical devices
• Re-classification of software based medical devices