https://www.tga.gov.au/resources/publication/publications/application-audit-technical-file-review-ivd-medical-device-applications
Application audit process
The following flowchart summarises the process for an application audit:
So, if in fact an audit is what is going on... it's a very positive sign indeed! Unless Rhythm/Sonic has made some error in the application, which is very unlikely, an audit would be the final step prior to listing on ARTG.
https://www.tga.gov.au/resources/publication/publications/applica...
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