Types of medical devices based on risk classification
Overview
Types of Medical Devices
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 |