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Classification of Medical Devices
Medical devices may be classified into 4 risk classes.

Class
Risk Lv
Examples
A
Low Risk
Surgical retractors / tongue depressors
B
Low-moderate Risk
Hypodermic Needles / suction equipment
C
Moderate-high Risk
Lung ventilator / bone fixation plate
D
High Risk
Heart valves / implantable defibrillator

Classification of a medical device will depend upon a series of factors, including:
How long the device is intended to be in use
Whether the device is invasive
Whether the device is implantable
Whether the device is active
Whether the device contains a drug or biologic component
The classification rules are adopted from the guidance developed by the Global Harmonization Task Force.