Categorization of Medical Devices

ClassGeneral ControlsRiskDescriptionExample
Class Ⅰ1) Sterile (Is)
2) Measuring (Im)
LowDevices that have least interaction with the bodyHospital beds, sterile plasters, weighing scales, thermometers etc.
Class ⅡaSpecial Controls required. May need special labelling, obligatory performance standards and post-market supervisionMediumDevices which are used to check or diagnose the medical conditions or are involved in the exchange of energy with the patient in a curative manner. Generally invasive, but limited to natural orifices. Included in Class Ⅱb if hazardous to patient.Hearing aid, electrical wheelchairs etc.
Class ⅡbSpecial Controls as Class ⅡaMediumSurgically invasive devices that are totally or partially implantable in the body and may modify the proportion of the body fluidsSurgical lasers, ventilators, infusion pumps etc.
Class ⅢPre-market approval is required to establish safety and effectiveness of these devicesHighSupport and sustain human life and are of utmost importance to prevent deterioration of human health or which present a possible unreasonable risk of injury or illness. Also includes devices that directly come in contact with the Central Circulatory System or comprise a medicinal productNeurological and Vascular implants, silicone-gel filled breast implants, replacement heart valves etc.

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