TSV

Types of Medical Devices - TSV

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