The TGA, Australia has provided guidance on the medical device inclusion process.
Who is the guidance for?
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