XML

Types of Medical Devices - XML

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
<?xml version="1.0" encoding="UTF-8"?>
<items>
  <item>
    <code>Class I</code>
    <slug>general-medical-devices</slug>
    <name>General Medical Devices (Class I)</name>
    <description>Devices with extremely low risk to the human body even if a malfunction occurs</description>
  </item>
  <item>
    <code>Class II</code>
    <slug>controlled-medical-devices</slug>
    <name>Controlled Medical Devices (Class II)</name>
    <description>Devices with relatively low risk to the human body if a malfunction occurs</description>
  </item>
  <item>
    <code>Class III</code>
    <slug>specially-controlled-medical-devices-high</slug>
    <name>Specially Controlled Medical Devices (Class III)</name>
    <description>Devices with relatively high risk to the human body if a malfunction occurs</description>
  </item>
  <item>
    <code>Class IV</code>
    <slug>specially-controlled-medical-devices-life-threatening</slug>
    <name>Specially Controlled Medical Devices (Class IV)</name>
    <description>High-risk devices directly linked to the patient&apos;s life</description>
  </item>
</items>