LIU Yi-sheng, ZHANG Guang-xiang, HUANG Wei-yu, LIANG Jin-yuan, LU Zhong, KONG Fan-pu
With the continuous development of aesthetic filler medical devices toward longer-lasting effects, tissue regeneration, and functional composite properties, product compositions, mechanisms of action, and clinical applications have become increasingly diversified, imposing higher requirements on non-clinical safety and efficacy evaluation. Animal experiments, as an important component of medical device registration evaluation, serve as key evidence for assessing biocompatibility, tissue response, degradation characteristics, and long-term safety of products. Based on China's Guidelines for the Registration Review of Animal Experiment Studies of Medical Devices, the GB/T 16886 series standards on Biological Evaluation of Medical Devices, the ISO 10993 series standards on Biological Evaluation of Medical Devices, and relevant domestic and international research progress, this paper systematically summarizes the regulatory requirements, general design principles, selection of animal models for different types of filler materials, observation periods, and evaluation priorities for animal experiments of aesthetic filler medical devices. It focuses on key evaluation techniques such as imaging, histopathological observation and quantitative analysis, and molecular biological approaches, as well as safety and efficacy evaluation indicators and statistical design requirements. The main problems existing in current animal experiments and key points of concern in registration review are also analyzed. In the future, the animal experiment evaluation system should be further improved; the application of new technologies such as imaging, digital pathology, artificial intelligence, and multi-omics in animal experiments should be promoted; and the implementation of risk management concepts and the 3R principles (Replacement, Reduction, and Refinement) should be strengthened, so as to advance the standardization, normalization, and precision of animal experiment evaluation, and provide technical references for the research and development, registration review, and clinical safe application of aesthetic filler medical devices.
