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.
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.
