Structured Lists Directory

Markdown

Types of Medical Devices - Markdown

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 |