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.
About this guidance
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
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.