The purpose of this guidance is to help sponsors and manufacturers comply with the requirements of the therapeutic goods legislation.
This is a guide only, and sponsors and manufacturers are encouraged to familiarise themselves with the legislative and regulatory requirements in Australia. If necessary, seek professional advice as it is the responsibility of each sponsor and/or manufacturer to understand and comply with these requirements.
This document will evolve over time and updates and clarifications will be included as required. Feedback on the guidance is always welcome.
Contents
How to vary an entry in the ARTG
Class III/AIMD variation application form
Device Change Request (Request Change) Application Form
