TOML

Types of Medical Devices - TOML

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

[[items]]
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"

[[items]]
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"

[[items]]
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"

[[items]]
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"