Abstract: The rapid development of nanomaterials has brought breakthrough opportunities for high-quality innovation in medical devices, but it has also become a new challenge for regulatory authorities. Scientific risk assessment of medical devices with nanomaterials is essential for its regulatory and clinical application. Different levels of risks determine different regulatory categories. To solve this problem, this study focuses on medical devices with nanomaterials, compares relevant regulatory requirements of medical device classification, sorts out current management situation, and proposes suggestions for high-quality development of medical devices.