A
AbsoluteBeginner
Hello- :truce:
we (german Company) want to register IVDs in Australia an i wonder how it works? It's my fist Job in "Regulatory Affairs", so i'm quite clumsy. I know that i have to submit a technical File. And i read about the GHTF. Can i just create a technical file like the STED? Is it a common procedure?
We develope the IVDs under consideration of certain DIN EN ISO. Do the Australiens have specific Standards which i have to take account?
Thank a lot in advance!!
we (german Company) want to register IVDs in Australia an i wonder how it works? It's my fist Job in "Regulatory Affairs", so i'm quite clumsy. I know that i have to submit a technical File. And i read about the GHTF. Can i just create a technical file like the STED? Is it a common procedure?
We develope the IVDs under consideration of certain DIN EN ISO. Do the Australiens have specific Standards which i have to take account?
Thank a lot in advance!!