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Reclassification of medical devices that administer medicines or biologicals by inhalation

Updated guidance to reflect new amendments made to the regulations.

Last updated

This guidance aims to assist sponsors of medical devices that administer medicines or biologicals by inhalation with meeting their obligations and outlines transitional arrangements to help comply with new regulations.

From 25 November 2021 medical devices that administer medicines or biologicals by inhalation will be required to meet regulatory requirements demonstrating the safety and efficacy of the product commensurate with the higher classification (Class IIa or Class IIb).

  • About this guidance
    • Background
    • Requirements for reclassification
  • Medical devices that administer medicines or biologicals by inhalation
    • Examples of devices to be reclassified
    • Devices pre filled with medicines or biologicals
  • 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
  • Application to transition
    • What to include in your application
    • How to submit a reclassification application
  • If your inclusion application is not successful
  • When to cease supply using your old ARTG entry

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