You are here

Reclassification of active implantable medical devices (AIMD)

Guidance on the transitional arrangements and obligations
12 May 2021
Download Reclassification of active implantable medical devices (AIMD)

Description

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

We aim to provide documents in an accessible format. If you are having problems using a document with your accessibility tools, please contact us for help.