Medical devices have been transforming in the past decades, digital technology incorporated in medical devices such as screening, diagnosis, monitoring, analysis, and many more.

Features such as to predict potential failures before they become a life-threatening scenario. As the amount of software used in medical devices has dramatically increased. TGA has enforced the regulation update to classify software-based medical devices according to their potential to cause harm through the provision of incorrect information.

Therapeutic Goods Administration Regulation on software-based medical devices has been amended and changes effective from 25 February 2021. The new classification rules have some similarities to the European Union Medical Devices Regulations (EU 2017 MDR).

Certain software that acts as a functional support system is excluded in this change. Few examples are:

  • 1. Consumer health products:
    • Wearable technology tracks fitness heart rate
    • - Coaching software intended to act as a tracking tool for an individual’s wellbeing with no serious condition
  • 2. Enabling technology:
    • - Software or system intended to administer or manage health processes or intended to store transmit patient images
  • 3. Digitization:
    • - Clinical report or doctor’s prescription which has paper-based copy but provided in electronic format
  • 4. Population-based analytics:

- Collection and analysis of group data that are not intended to be used for clinical use cases for individuals

  • 5. Laboratory Information Management Systems:

- Software used to manage laboratories operation and samples management

Classification regulations have been amended for software-based medical devices that provide intended functions below:

a) diagnosis or screening

b)performs diagnosis or screening

c) a relevant health professional performs the diagnosis

d) monitoring

e) specification or recommendation of a treatment or intervention

f) software specifies or recommends a treatment or intervention

g) software recommends a treatment or intervention to a relevant health professional

h) software provides information as therapy

The diagram below describes the latest regulations applicable to software with different intended purposes.



Intended Purpose of Software and the Relevant Classifications


Diagnosis of diseases or conditions


Monitoring the state or progression of a disease or condition


Specification or recommendation of a treatment or intervention


Provision of information as a form of therapy

Keeping up with digital transformation in healthcare and adapting to updated regulation in each country can be overwhelming, Qualtech is a team of professional expertise in regulatory and market access strategy, we understand the importance of the business and the regulatory compliance.

We are dedicated to providing you with the best service, updated regulations, and ease the transition for you.