Animal testing is one of the important methods in the evaluation of the safety and effectiveness of medical devices. The preclinical animal testing of medical devices is an important project that many Class III medical devices, especially innovative medical devices, need to be carried out before clinical trial research. This review provides a reference for standardizing the development of preclinical animal test research on medical devices.
Methods: This article summarizes the preclinical animal test research of medical devices at home and abroad on the basis of regulations and standards, and refers to the framework of the "Non-clinical Drug Non-clinical Research Quality Management Code" to summarize the main considerations for medical device preclinical animal test research. tidy.
Results: This article summarizes the pre-clinical animal test research of medical devices from several aspects such as personnel, facilities, equipment and experimental materials, test systems, standard operating procedures, research implementation, summary reports, and quality assurance and data files. Consider the main points.
Conclusion: This article provides a more comprehensive understanding of pre-clinical animal test research for medical devices, and provides a reference for conducting animal test research.
Researchers related to animal experiment research should include different technical personnel, such as clinicians, veterinarians, and researchers in the professional fields of veterinary pathology and imaging. Archives of all training and practice experiences and job descriptions of all personnel engaged in animal experiment research or supervising animal experiment research should be kept.
The experimental facility should have an information sheet about animal identification, experimental grouping, type of procedure performed, and the fate or disposal of each animal, so that any individual test and control animals are supervised.