You are here

Reclassification of active medical devices for therapy with a diagnostic function

Guidance on the transitional arrangements and obligations
12 May 2021
Download Reclassification of active medical devices for therapy with a diagnostic function

Description

This guidance aims to assist sponsors of active medical devices for therapy with a diagnostic function with meeting their obligations and outlines transitional arrangements to help comply with new regulations.

From 25 November 2021 active medical devices for therapy with a diagnostic function will be required to meet regulatory requirements demonstrating the safety and performance for Class III medical devices.

  • About this guidance
  • Active medical devices for therapy with a diagnostic function
  • What you need to do
  • Notifying the TGA
  • Class III applications for ARTG inclusion
  • 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.