Medical Device Reforms in Australia

The Therapeutic Goods Administration (TGA), the regulatory body for therapeutic goods in Australia, had previously announced that various medical device reforms would be enacted from 2019 through 2024. The transition period was (and still is) set to end on October 31, 2024. However, this summer, TGA announced a delay in the commencement of the medical device reforms due to COVID-19. So, the medical device industry has more time to adapt to the reforms. We have compiled some of the more significant Australian medical device reforms below.

Significant amendments regarding software-based medical devices (including SaMD):

  • The classification rules are “largely aligned with the software rules in the EU MDR 2017.” Thus, classification is based on the potential of the SaMD to cause harm through the provision of incorrect information.
  • A device may be a lower classification if a healthcare professional is involved
  • Devices intended to provide therapy via the provision of information (e.g., a medical device intended to provide cognitive behavioural therapy) will potentially be a higher class in some cases.
  • Clarifications around Essential Principle 12.1 (expectations regarding cybersecurity, data management, etc.)
  • Addition of Essential Principle 13B (requiring identification of the current version and build number to be made accessible by, and identifiable to, users of medical devices that are, or that incorporate, software)

These reforms will be implemented February 25, 2021. As for the Essential Principles amendments, their implementation has been delayed for up to two years after the commencement of European Union Medical Device Regulation changes and IVD Medical Device Regulations (likely to be May 2022).

Significant device reclassifications:

The device reforms have also brought about some up-classification. The list below is general; some exceptions remain to the new classifications.

  • Spinal implantable medical devices are moving from Class IIb to Class III
  • Active medical devices for therapy with diagnostic function are moving from Class IIa/b to Class III
  • Active implantable medical devices are moving from Class AIMD to Class III
  • Medical devices that administer medicines or biologicals by inhalation are moving from Class I or IIa to Class IIa or IIb
  • Medical devices composed of substances that are introduced into the body through a body orifice or applied to the skin are moving from Class I or IIa to Class IIa, IIb, or III
  • Medical devices used in direct contact with the heart, central circulatory or central nervous systems are moving from Class IIa to Class III

These reforms will be implemented November 25, 2021.


See our other posts on TGA here:

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

SoftwareCPR Training Courses:

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering:  June 5-7, 2024
Boston, MA

Email to request a special pre-registration discount.  Limited number of pre-registration coupons.

Registration Link:

Register Now



Being Agile & Yet Compliant (Public or Private)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for scheduling!

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering: February 12-15, 2024

Virtual via Zoom

Registration Link:

Register Now



Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering:  TBD

Corporate Office

15148 Springview St.
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN, TX) and Canada.