CFDA Requests Biocompatibility Evaluation for Raw Materials

pittmatj

Involved In Discussions
#1
Our company is undergoing a re-registration and the CFDA reviewer has requested biocompatibility evaluation reports for the raw materials in our medical devices. We have already provided the reports for the finished product.

My understanding is that it is permissible according to ISO 10993-1 to test the finished product. Note, our medical devices are low-risk, non-invasive, and non-sterile

Is this typical to require evaluation reports for the raw materials? Does anyone have the specific regulation from China?

Thanks.
 
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M

MIREGMGR

#2
I love biocompatibility evaluation rules. :notme:

US FDA has been giving me a hard time lately on a couple of applications because we documented the products involved per their constituent materials, and for the device type in question, FDA now will only accept finished device evaluations.

It's a merry go round.
 
N

NSFountou

#3
If the regulator that required the testing did not provide the standards... try to reach out to them to get the standards. As a caveat, it is an unusual request, but nevertheless your best resource is the CFDA contact.
 
M

MIREGMGR

#4
Sorry, I should have answered better before.

I don't have the cross reference list readily available, but CFDA uses China nationalized versions of ISO and IEC standards in most cases. My understanding is that they have adopted the ISO 10993 series in that sense. So, I think your situation is not that their standard specifically calls for something different from what rest-of-world standards require. Rather, it might be a matter of interpretation or institutional preference.
 

pittmatj

Involved In Discussions
#5
If the regulator that required the testing did not provide the standards... try to reach out to them to get the standards. As a caveat, it is an unusual request, but nevertheless your best resource is the CFDA contact.
That's a good idea, thanks. Up to this point, we have been communicating through our registrar in China.
 

pittmatj

Involved In Discussions
#6
Sorry, I should have answered better before.

I don't have the cross reference list readily available, but CFDA uses China nationalized versions of ISO and IEC standards in most cases. My understanding is that they have adopted the ISO 10993 series in that sense. So, I think your situation is not that their standard specifically calls for something different from what rest-of-world standards require. Rather, it might be a matter of interpretation or institutional preference.
Thanks. I found this file(attached) from another thread- is it the most updated version of the standards from the CFDA?
 

Attachments

M

MIREGMGR

#7
I don't read Chinese, but the accompanying plain text implies that this is a 2007 document. I'm under the impression that they issue updates several times a year.

That's not to say that the information in this document necessarily has changed. I don't think it's "latest", though.
 
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