Abstract: Objective To introduce the test methods of embryo toxicity applied to medical devices for human assisted reproductive technology (ARTMD), and provide the evaluation reference. Methods The embryo toxicity test methods of ARTMD were summarized, and the key procedures and challenges in their safety evaluation were also discussed. Results Establishing sensitive and stable test system is important to guarantee the safety and efficacy of ARTMD. Conclusion It remains development opportunities in improving sample preparation, extending test technology and expending evaluation method.