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Reclassification of active implantable medical devices (AIMD)

This guidance is to assist sponsors comply with new regulations.

Last updated

This guidance aims to assist sponsors of active implantable medical devices (AIMD) with meeting their obligations and outlines transitional arrangements to help comply with new regulations.

From 25 November 2021 active implantable medical devices will be required to be reclassified from Class AIMD to Class III.

Contents

  • About this guidance
    • Background
  • Active implantable medical devices
    • 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
      • Cancelling your ARTG inclusion
    • Applications to include a new medical device on or after 25 November 2021
    • Annual Reporting Requirements
  • Notifying the TGA
  • Class III applications for ARTG inclusion
    • How to submit a reclassification application
    • What to include in your application
  • Fees and charges
  • Amendments to Prostheses List
  • If your inclusion application is not successful
  • When to cease supply using your old ARTG entry

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