Well done Derek and co.Quality submission process.

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01/03/22

18:35

Post #: 59907563
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Originally posted by bariscan90: ↑

Hi all, I have some information about the TGA application process for rapid antigen tests. I exchanged e-mails with someone from the Medical Devices Information Unit at the TGA. I will post this information on Lumos Diagnostics(LDX) forum as well.

All the Covid rapid antigen test applications are being expedited. I wasn't able to get the exact date when they began prioritising these applications from the TGA. Due to the volume of applications in queue, the timeframe from start to finish is approximately 1-4 months, and this is inclusive of the requests for further information. Although, the timeframe is 1-4 months, the total timeframe will vary depending on the quality of information and the speed it is supplied when requested. When a company is asked for further information, the clock on the application is stopped until a response is received. Once the response is received, the clock will be reactivated and the application will go back into the assessment queue, so to the end of the queue. If a request for information does not receive a response by the due date, the application is considered to be lapsed. At this point, the TGA will send an additional notification to follow up on the request. I hope this helps.

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Well done Derek and co.
Quality submission process.

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Well done Derek and co.Quality submission process.

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