INI

Types of Medical Devices - INI

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

[item.general-medical-devices]
code=Class I
slug=general-medical-devices
name=General Medical Devices (Class I)
description=Devices with extremely low risk to the human body even if a malfunction occurs

[item.controlled-medical-devices]
code=Class II
slug=controlled-medical-devices
name=Controlled Medical Devices (Class II)
description=Devices with relatively low risk to the human body if a malfunction occurs

[item.specially-controlled-medical-devices-high]
code=Class III
slug=specially-controlled-medical-devices-high
name=Specially Controlled Medical Devices (Class III)
description=Devices with relatively high risk to the human body if a malfunction occurs

[item.specially-controlled-medical-devices-life-threatening]
code=Class IV
slug=specially-controlled-medical-devices-life-threatening
name=Specially Controlled Medical Devices (Class IV)
description=High-risk devices directly linked to the patient's life