Is an English version of CFDA YY0664-2008 available?

P

ps_alsa

After receiving the document "Requirements on Declaration of Description Document for Medical Device Software", I've to compile a document according (I think...) with YY0664-2008.
I would know if an English Version is available and if is it similar to IEC 62304 "Medical device software - Software life-cycle processes".

Thanks
Paolo
 
Jen Kirley

Jen Kirley

Quality and Auditing Expert
Leader
Admin
Re: Is an English version of CFDA YY0664-2008 eavailable?

A quick bump...

Can anyone help?
 
O

Oscar Wang

Re: Is an English version of CFDA YY0664-2008 eavailable?

ps_alsa said:
After receiving the document "Requirements on Declaration of Description Document for Medical Device Software", I've to compile a document according (I think...) with YY0664-2008.
I would know if an English Version is available and if is it similar to IEC 62304 "Medical device software - Software life-cycle processes".

Thanks
Paolo
Click to expand...

Hello, you are right. China standard YY/T0664-2008 is identical to IEC 62304:2006 which is just a translation version.:)
 
P

ps_alsa

Re: Is an English version of CFDA YY0664-2008 eavailable?

Thanks Oscar!
Rgds
Paolo
 
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