CFDA Biological Evaluation Report

Gamula

Involved In Discussions
#1
Dear Elsmar cove-dwellers,

I hope that someone is knowing about te biological evaluation report, which has to be written in certain cases: "CFDA Notice on issuing guidance for Biological Evaluation and Review of Medical Devices (国食药监械[2007]345号).

I received this because it shall be written after DIN EN ISO 10993-1 biocompatibility testing. Now, I cannot find out where and why it is applicable (depending on class? depending on the kind of thedevice?)? Furthermore, I read that you can avoid testing by writing.

Does someone has experience in writing a biological evaluation report? Maybe, it is very easy or it is tremendous tough?

Thanks for any feedback on this issue! :tg: :tg: :tg:
 
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Marcelo

Inactive Registered Visitor
#2
Not that difficult, if written by a toxicologist with knowledge of the requirements of the 10993 series. You can avoid testing if enough good data exists to enable a risk assessment, but it's not that simple.

It's applicable, in general, if the device has direct or indirect contact with tissues, cells, etc.
 

Gamula

Involved In Discussions
#3
:agree1: Thanks!


I got your point and the quality of the data is the nub of the matter because we cannot assess the quality of the available data now. Especially, the devices I am working on are no ones in Europe but class I in China. Furthermore, the toxicologist who is aware of 10993 will und unfortunately won´t be available here :confused:
I think this is not common writing it instead of testing and submitting the test reports, although I found this option.

So, it is a matter of risk appetite :cool:

:thanks: again!!!
 
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