Abstract: Animal research of medical devices/medical materials is an essential part of preclinical safety and efficacy evaluation. Many questions should be taken in considerations when it comes to design and conduction animal research of medical devices/medical materials because of its uniqueness. This kind of research has widespread studying objects while has no universal standard method, and should be designed case-by-case. This article is aimed at serving as a reference for sponsors and researchers when performing preclinical safety and efficacy evaluation of medical devices/medical materials.