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
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
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.