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Reclassification of active implantable medical devices (AIMD)
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
- What you need to do
- Notifying the TGA
- Class III applications for ARTG inclusion
- 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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