Mike,

> 
> Does anyone know:
> 
> 1) Standards for medical devices in Japan and Australia?
> 2) Approval procedure for medical devices in Japan and Australia?

Try http://www.ita.doc.gov/td/mdequip/Australiaregs.html for Australia

and http://www.ita.doc.gov/td/mdequip/japanregs.html for Japan


> 
> Any help/direction would be appreciated.
> 
> Thanks,
> 
> Mike Cantwell
> 
> 

Regards,
Jon Griver
www.601help.com
The Medical Device Developer's Guide to IEC 60601-1


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