TGA provides guidance on the medical device inclusion process

The TGA, Australia has provided guidance on the medical device inclusion process.

Who is the guidance for?

It is intended for sponsors applying for inclusion of a ‘kind of medical device’, including IVD medical devices, in the Australian Register of Therapeutic Goods (ARTG).

In what format has the guidance been provided?

There are 9 steps (from 1 to 9) in the medical device inclusion process. For each step, a link is provided to the appropriate web page.

The web pages:

  • identify the process you will need to follow to include your device in the ARTG,
  • navigate you through the inclusion processes step-by-step,
  • contain hyperlinks to the regulatory and technical guidance, and application forms you will need to complete each step in the process, and
  • identify when the process is complete.
Update on 20 May 2021

Further information on the Therapeutic Goods (Medical Devices-Application Form for Inclusion) Approval 2021 is available here.

Source: TGA website