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Types of Medical Devices - JSON

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"
  }
]