Anyone Work at TGA or Healthcare and Familiar on How to Get an Approval for a Medical Device to Be Registered on ARTG?

PaperplaneXXX on 07/08/2023 - 19:32

Hi all,

Story short. I need to know please the list of documents Sponsors normally submit to TGA to get an approval for a medical test for example like a serology for detection of some disease in human serum?
And probably the whole process if someone can shed some light, maybe in personal messages.

Let's say a Sponsor - medical Company needs to put a new test on the market and register on ARTG?
what's the process they would follow and what documents they need to submit. Any evidence of validation, calibration ect ?

cheers all

Xxx

Health & Beauty

Comments

cuteduck on 07/08/2023 - 19:51

+1

Some pharmaceutical companies use https://www.pharmatomarket.com/
- capslock janitor on 07/08/2023 - 21:26
  
  Do I know u
sumyungguy on 07/08/2023 - 21:54

Factual link
poboy on 07/08/2023 - 22:35

+1

Is this a class 1 medical device or class 2?
- PaperplaneXXX on 08/08/2023 - 20:39
  
  CLASS II
TheRealCher on 08/08/2023 - 16:58

Bikies

Anyone Work at TGA or Healthcare and Familiar on How to Get an Approval for a Medical Device to Be Registered on ARTG?

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