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Reclassification of active medical devices for therapy with a diagnostic function

This guidance is to assist sponsors comply with new regulations.

Last updated

This guidance aims to assist sponsors of active medical devices for therapy with a diagnostic function with meeting their obligations and outlines transitional arrangements to help comply with new regulations.

From 25 November 2021 active medical devices for therapy with a diagnostic function will be required to meet regulatory requirements demonstrating the safety and performance for Class III medical devices.

  • About this guidance
    • Background
    • Requirements for reclassification
  • Active medical devices for therapy with a diagnostic function
    • Examples of devices to be reclassified to Class III
  • What you need to do
    • Medical devices included in the ARTG prior to 25 November 2021
    • Applications to include a medical device in the ARTG lodged before 25 November 2021
    • Applications to include a new medical device on or after 25 November 2021
  • Notifying the TGA
  • Class III applications for ARTG inclusion
    • Kind of device: Class IIa/Class IIb vs Class III
    • What to include in your application
    • How to submit a reclassification application
    • Mandatory audits
    • Fees
  • If your inclusion application is not successful
  • When to cease supply using your old ARTG entry

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