Covestro medical polycarbonates have been safely used in a variety of medical devices for decades. Medical devices category III is highly regulated in China and needs premarket approval by the China Food and Drug Administration (CFDA). Registration of medical devices category III is quite challenging and is becoming demanding for applicants.
Part of the challenge is biocompatibility assessment on raw materials. Although the CFDA is not authorized to regulate raw materials, experts who review the dossiers typically inquire about the biocompatibility of raw materials and how it’s conducted.
As a consequence, the CFDA requires more and more supporting documentation to evaluate the biocompatibility assessment of devices. This includes the biocompatibility assessment report of a raw material, if available. According to the CFDA, biocompatibility assessment of raw materials shall take into account not only the biocompatibility testing data but also the established history of safe use and the results available from previously completed relevant studies. Makrolon® polycarbonate from Covestro has over 40 years of successful application history registered with the United States Food and Drug Administration, which is one type of acceptable history of safe use.
If the existing pre-clinical and clinical data meet the requirements of biological evaluation, then repeated biological testing would not be recommended. Moreover, further animal testing would be unethical.
The CFDA not only accepts the biological testing reports issued by the CFDA-certified national testing laboratories in China but also Good Laboratory Practice (GLP)-certified testing laboratories in overseas countries. Covestro’s Product Safety & Regulatory Affairs Department in Asia Pacific fully supports its customers’ registration in China by providing relevant documents of biocompatibility assessment for key Covestro medical Makrolon® grades prepared by GLP laboratories.
If the CFDA requires information about biocompatibility assessment of specific Covestro medical polycarbonate grades used in a customer’s registration device, the customer can contact his local Covestro account manager for further assistance.
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