Yeah, fair enough.
Here is a link to a TGA webpage that details what the process is for a manufacturers evidence application.
https://www.tga.gov.au/manufacturer-evidence-medical-devices-and-ivd-medical-devicesI am not sure if this is the exact process that Rhythm would be going through but it gives an idea of how structured and prescribed the process would be. This step just gets Rhythm, as a manufacturer, into the TGA system and allows them to log in and lodge and manage any product applications they have with the TGA. It is effectively pre-vetting about who can lodge applications with the TGA.
Bottom line is they make the application, within 2 days they get confirmation that the application has been lodged and then the TGA attempts to complete the process within 15 working days. If they fail this time - and there is absolutely no reason I know of why they would fail - they can keep applying as many times as they want.
Until Rhythm is accepted by the TGA as being a manufacturer they cannot make an application for ColoSTAT to be registered by the TGA. I read somewhere that the target TGA sets itself for processing products like ColoSTAT is 80 working days but I suspect they might be unusually busy because of COVID.
