Guidelines For Technical Review Of Registration Of Animal-Derived Medical Devices (2017)(Final)

The guideline is intended to guide registration applicantsin preparing registration materials for animal-derived medical devices. Some medical devices may contain materials of animal origin. These materials are diverse. They can constitute the main components of the device (such as bovine / pig-derived heart valves, sheep gut sutures, hemostatic materials, etc.), coatings, or infiltration agents (such as heparin, gelatin, collagen, etc.) , and can also become auxiliary materials used in the production (such as tallow, etc.). The use of animal tissues and their derivatives may give medical devices better performance than non-biologically derived materials such as metals, plastics, and fabrics. However, on the other hand, their application to the human body will increase the safety risks of virus transmission and immunogenicity, and there are difficulties in material characterization. Therefore, the evaluation of the safety of animal medical devices needs to consider more aspects than conventional medical devices. If the registration applicant has the above considerations when preparing the medical device registration application documents, it will help to more fully and scientifically evaluate the risk-benefit ratio of medical device products.

The guideline is based on the general requirements of the technical documents (study data, risk analysis documents, product technica requirement, and IFU) in the registration application documents, and the requirements for special attention and additional discussion on the characteristics of animal-derived medical device products. In addition, registration applicants should also comply with the “Administrative Measures for the Registration of Medical Devices” (China Food and Drug Administration Decree No. 4), “Administrative Regulations on the IFU and Labels of Medical Devices” (China Food and Drug Administration Decree No. 6), “Announcement on Publication of Medical Device Registration Information Requirements and Approval Document Format” (China Food and Drug Administration Announcement No. 43 of 2014) and other related document requirements issued by the State Administration and refer to YY/T 0771 / ISO 22442 standard series and other technical documents to submit registration application documents. Registration applicant should determine whether the specific content is applicable based on the characteristics of the specific product. If it is not applicable, the reason and corresponding scientific basis shall be elaborated. Registration applicant should also enrich and refine the contents of registration application documents based on the characteristics of specific products