China SFDA Medical Device Software Requirements

S

spectra123

#11
Hello Everyone,

We have been asked to provide a software description document to SFDA. Is there a English version of the guidance document available from SFDA? Any help is greatly appreciated.

Thanks.

ST
 
Elsmar Forum Sponsor
S

spectra123

#13
Thanks Joanne for pointing it out . I missed going to page 2! Can anyone please post recent experiences dealing with SFDA with respect to software description document? Reading through the document, it looks like they require us to submit the technical file / design control file. There is a concern of providing proprietary information to SFDA. Any thoughts on how to handle it? Thanks in advance.

Regards,

ST
 
C

CBAL08

#14
We have submitted the document as per the sections provided in the SFDA document. We worte our Sofwtare document exactly as it was mentioned in the SFDA document. Each sections and headings and made it compatible to what they were asking for. ( Like we do for 510K application). I hope this helps.
 
C

CABRAC

#15
I am currently creating the document to respond to this CFDA software request. I would like to hear others experiences with CFDA on this particular document. Has anyone received approval? Has anyone received a government query specifically about what they submitted for Software?

Thank you in advance!
 
R

rsavoie

#16
Hi CABRAC,
We also followed the template as in the SFDA guidance document and received approval. So it can work!
I was reading that there are some incoming changes to this process very soon, so make sure to look on the SFDA website (now CFDA like you mentioned) and other sources to ensure you are up to date before submission.
 
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