YAML

Types of Medical Devices - YAML

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: "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"
- 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"
- 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"
- 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"