CSV

Types of Medical Devices - CSV

Medical devices are classified based on the risk to the human body in the event of malfunction. In Japan, they are classified into four levels from Class I to IV, and in the US FDA, into three levels from Class I to III.

Medical Devices Healthcare Medical Classification
code,slug,name,description
Class I,general-medical-devices,General Medical Devices (Class I),Devices with extremely low risk to the human body even if a malfunction occurs
Class II,controlled-medical-devices,Controlled Medical Devices (Class II),Devices with relatively low risk to the human body if a malfunction occurs
Class III,specially-controlled-medical-devices-high,Specially Controlled Medical Devices (Class III),Devices with relatively high risk to the human body if a malfunction occurs
Class IV,specially-controlled-medical-devices-life-threatening,Specially Controlled Medical Devices (Class IV),High-risk devices directly linked to the patient's life