Legal analysis: the main body of responsibility for medical devices, including the development of medical devices, production units, business units and supervision units. Medical devices are instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials and other similar or related items used directly or indirectly for the human body, including the required computer software. Medical devices include medical equipment and medical consumables. Their purpose is the diagnosis, prevention, monitoring, treatment, or mitigation of disease; the diagnosis, monitoring, treatment, mitigation, or functional compensation of injury; the testing, substitution, regulation, or support of physiological structures or processes; the support or maintenance of life; the control of pregnancy; and the provision of information for medical or diagnostic purposes through the examination of specimens from the human body.
Legal basis: "Medical Devices Supervision and Administration Regulations" Article 4 Local people's governments at or above the county level shall strengthen the supervision and management of medical devices in the administrative region of the leadership, organization and coordination of supervision and management of medical devices in the administrative region as well as the response to emergencies, and to strengthen the supervision and management of medical devices capacity building, to provide protection for the safety of medical devices.
Local people's governments at or above the county level are responsible for drug supervision and management of the department responsible for the supervision and management of medical devices in the administrative region. The relevant departments of the local people's government at or above the county level are responsible for the supervision and management of medical devices in their respective areas of responsibility.