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Clinical evidence guidelines for medical devices

Guidance on the clinical evidence requirements for medical devices, including in-vitro diagnostic medical devices (IVDs), under Australian legislation. 

Published
Last updated

Purpose

Medical device clinical evidence requirements, including IVDs, are outlined in this Guidance.

Both industry and regulators can use this guidance as a reference. Sponsors and manufacturers can use this guidance to collect, compile, and present clinical evidence.

Legislation

Guidance

This Guidance is presented as downloadable files because of its length. 

Downloads

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Topics

Page history

Show all page updates (8)

Section added for Use of computational modelling and simulation.

Title changed from 'Clinical evidence guidelines' to 'Meeting clinical evidence requirements for medical devices' as part of migration to new 'Guidance' content type:

  • Consistent ‘Purpose’ heading.
  • ‘Legislation’ section to clearly show which laws the Guidance relates to.
  • ‘Page history’ section replaces document version history.
  • New page navigation features.
  • Updated page summaries.
  • Complex images include long descriptions.
  • New ‘Save as PDF’ feature.

Summary of changes:

  • new chapters on Ophthalmic devices and medical devices incorporating a medicine
  • changes to Surgical mesh and Breast implants and tissue expander
  • added references to Real World Data and Real-World Evidence
  • changes to reflect recent TGA experience with clinical evidence for a range of medical devices.

Details of changes: 

  • transferred to new template
  • updated Part 1 - General Requirements - Other clinical experience data - Real World Data (and Real World Evidence)
  • updated Part 2 to include - Medical devices incorporating a medicine
  • updated Part 3 to include – Ophthalmic devices
  • v3.1 previously combined Part 3 'Supportive Devices - Meshes, patches and tissue adhesives' has been separated into two: 'Supportive Devices - Surgical Mesh' and 'Supportive Devices - Central nervous system (CNS) patches and tissue adhesives’
  • updated Part 3 – Supportive devices – Surgical Mesh
  • updated Part 3 – Breast Implants and Tissue Expanders
  • updated - Abbreviations.

Summary of changes: 

  • Updated Part 1 – General Requirements – The Essential Principles.
  • New chapter - Personalised medical devices (PMDs).
  • Updated - Total and partial joint prostheses.
  • New chapter - Software as Medical Device.
  • Updated - Abbreviations.

Updated Part 1 – General Requirements and overall structure. 

Updated links.

Updated section on Comparable devices including substantially equivalent devices.

Updated links and footnotes.

Minor updates to reflect CTA name change.

Original publication.

Section added for Use of computational modelling and simulation.

Title changed from 'Clinical evidence guidelines' to 'Meeting clinical evidence requirements for medical devices' as part of migration to new 'Guidance' content type:

  • Consistent ‘Purpose’ heading.
  • ‘Legislation’ section to clearly show which laws the Guidance relates to.
  • ‘Page history’ section replaces document version history.
  • New page navigation features.
  • Updated page summaries.
  • Complex images include long descriptions.
  • New ‘Save as PDF’ feature.

Summary of changes:

  • new chapters on Ophthalmic devices and medical devices incorporating a medicine
  • changes to Surgical mesh and Breast implants and tissue expander
  • added references to Real World Data and Real-World Evidence
  • changes to reflect recent TGA experience with clinical evidence for a range of medical devices.

Details of changes: 

  • transferred to new template
  • updated Part 1 - General Requirements - Other clinical experience data - Real World Data (and Real World Evidence)
  • updated Part 2 to include - Medical devices incorporating a medicine
  • updated Part 3 to include – Ophthalmic devices
  • v3.1 previously combined Part 3 'Supportive Devices - Meshes, patches and tissue adhesives' has been separated into two: 'Supportive Devices - Surgical Mesh' and 'Supportive Devices - Central nervous system (CNS) patches and tissue adhesives’
  • updated Part 3 – Supportive devices – Surgical Mesh
  • updated Part 3 – Breast Implants and Tissue Expanders
  • updated - Abbreviations.

Summary of changes: 

  • Updated Part 1 – General Requirements – The Essential Principles.
  • New chapter - Personalised medical devices (PMDs).
  • Updated - Total and partial joint prostheses.
  • New chapter - Software as Medical Device.
  • Updated - Abbreviations.

Updated Part 1 – General Requirements and overall structure. 

Updated links.

Updated section on Comparable devices including substantially equivalent devices.

Updated links and footnotes.

Minor updates to reflect CTA name change.

Original publication.