Regulatory Changes for Software Based Medical Devices in Australia

The Therapeutic Goods Administration (TGA) oversees the regulation of software-based medical devices. This includes software that serves as a medical device on its own as well as software that controls or interacts with a device, whether integrated or external. Any product considered a medical device must be listed in the Australian Register of Therapeutic Goods (ARTG), unless specifically exempt, before it can be legally marketed in Australia.

Following extensive consultation with stakeholders and international regulators between 2019 and 2020, the Therapeutic Goods (Medical Devices) Regulations 2002 were updated to clarify existing requirements and introduce new obligations for software-based medical devices.

These amendments, which took effect on 25 February 2021, include:

• clearer definitions of which software products fall under regulation (including “carve‑outs”) 
• new classification rules for software-based devices 
• updates to essential principles to better articulate requirements applicable to software 

Carve‑Outs

As of 25 February 2021, several software-based medical devices were either exempted or excluded from TGA regulation. These carve‑outs follow two main principles:

• alignment with international regulatory frameworks, where appropriate 
• elimination of unnecessary regulatory burden by avoiding regulation of: 
  • products presenting minimal safety risk 
  • products adequately governed by other oversight systems 

Certain clinical decision support systems (CDSS) have been exempted. CDSS refers to software that can perform a variety of functions that support clinical practice.

Other software categories have been excluded entirely and are not subject to TGA requirements, including:

• consumer health products that assist with prevention, management, or follow‑up but do not provide specific treatment advice 
• enabling technologies used for telehealth, healthcare delivery, or dispensing 
• digitization tools, such as simple dose calculators or electronic patient record platforms 
• population‑level analytics tools not intended for individual clinical decision‑making 
• laboratory information management systems (LIMS), such as systems used in pathology or radiology to automate workflows and manage orders, samples, and related information 

New Classification Rules

Diagnosis or Screening

Software that provides a diagnosis or screens for a disease or condition is classified based on whether:

• the software delivers the diagnosis or screening result directly, or 
• the diagnosis is made by a qualified health professional using information generated by the software 

This applies to software intended for:

• screening asymptomatic individuals for risk factors or early signs of disease 
• diagnosing symptomatic individuals to determine the cause of illness 

Monitoring

Software designed to monitor a disease or condition is classified according to:

• the potential public health impact, and 
• whether the information produced could indicate that a person is in danger 

“Danger” includes both immediate danger and situations where harm may occur but not immediately.

Treatment or Intervention Recommendation

Software that specifies or recommends a treatment or intervention is classified according to whether:

• the software itself determines the treatment or intervention, or 
• the software provides a recommendation that a health professional may choose to follow 

This applies to devices that:

• specify treatment directly, or 
• present recommendations while leaving the final decision to the user 

Information as Therapy

For software that provides therapy by delivering information, classification depends on the potential level of harm. Four harm categories are considered:

• harm leading to death or severe health deterioration 
• serious harm 
• non‑serious harm 
• no harm 

Changes to the Essential Principles

Manufacturers and sponsors must demonstrate compliance with the Essential Principles when supplying medical devices in Australia.

Beginning 25 February 2021, several updates affecting programmed or programmable medical devices were made:

• Essential Principle 12.1 was revised to clarify requirements for: 
  • cybersecurity 
  • data and information management 
  • development, production, and maintenance controls 

• Essential Principle 13.2(3) now allows electronic provision of information, instead of requiring printed leaflets 

A new Essential Principle, 13B, requires that the current software version and build number be accessible and identifiable to users of software‑based medical devices