The definition of medical devices as stipulated in Chapter VIII of the "Regulations on the Supervision and Administration of Medical Devices" (Order No. 650 of the State Council of the People's Republic of China) refers to instruments, equipment, devices, diagnostic reagents and calibrators, materials, and other similar or related items that are directly or indirectly used on the human body, including the required computer software.

Medical device user units refer to the institutions that use medical devices to provide medical and other technical services for others. These include medical institutions that have obtained the medical practice license, family planning technical service institutions that have obtained the practice license for family planning technical services, as well as blood stations, single plasma collection stations, and rehabilitation assistive device adaptation institutions that do not need to obtain the medical practice license in accordance with the law.