Compared with the United States and the European Union, the supervision of medical devices in China began later, but China has always viewed the quality and safety of medical devices as very important. In 1996, China issued the “Medical Device Product Registration Management Measures,” which requires that any medical device product that enters the Chinese market after January 1, 1997, must be registered by the Chinese Government Medical Device Registration Authority. The product manufacturer or its authorized agent should submit an application for product registration. In 2000, China issued the Regulations on the Supervision and Administration of Medical Devices to enhance the supervision and management of medical devices, ensure the safety and effectiveness of medical devices, and promote the development of the industry. The regulations were subsequently revised in 2014 and 2021. The latest regulations supplement and improve the aspects of risk management, full-process control, scientific supervision, and social cogovernance, ensuring the safety and effectiveness of medical devices. In the field of 3D-printed custom-made medical devices, although supervision in China began later than that in the United States and the European Union, its development is relatively more complete. China has initially established a systematic medical 3D printing supervision system, including a regulatory system, standard system, guideline system, and product system (Gao et al. 2023a, b). This chapter will elaborate on the process of establishing the medical 3D printing regulatory system in China, as well as the results of this system.