On January 5th, 2018, CFDA released a “Medical Device Clinical Trial Design Guidelines.” Here is a summary of the scope, purpose and coverage of this document.
This guideline is intended to guide registered applicants in the preparation of registration declarations for animal-derived medical devices. Some medical devices may contain animal-derived materials that are diverse and can form the major components of the device (eg, bovine / porcine heart valves, suture, hemostatic, etc.), coatings or impregnation Agents (such as heparin, gelatin, collagen, etc.) can also be used as ancillary materials in the manufacturing process (eg, tallow, etc.). The use of animal tissues and their derivatives may give better performance to medical devices than non-biological sources such as metals, plastics and fabrics, but on the other hand, their application to humans in turn increases the spread of viruses And immunogenicity and other aspects of the security risks, and the existence of material characterization difficulties, so the evaluation of the safety of animal-derived medical devices, the need to consider more than conventional medical devices more aspects. If the registered applicant in the preparation of medical device registration information when the above considerations, will help to more fully and scientifically evaluate the risk-benefit ratio of medical device products.