I want to register IVDs (CE) in Australia

[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!!

 

[lilybef]

A sponsor located in Australia is the only entity that can register products with the TGA. The manufacturer cannot do the registration unless they are located in Australia. The TGA website http://www.tga.gov.au/industry/devices.htm is extremely well organized and will have most of the information you are looking for, including what needs to be included in the submission. They do use the STED documentation format for submissions. Good Luck!

 

[AbsoluteBeginner]

Thank you

 

[Ronen E]

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!!

Hi,

If your devices are already EC certified / duly CE marked then you may not have to submit a technical file. For full details you may consult the TGA's guidance document on medical devices:

http://www.tga.gov.au/industry/devices-argmd.htm

If you require closer assistance please drop me a private message. I'm located in Australia and have gone through sponsoring / "registration" of medical devices in Australia (actually it's called "inclusion" here).

Good luck,
Ronen.