India CDSCO Medical Device Classification
The MDR 2017 Guidelines serve as the foundation for the Indian CDSCO classification system, which is based on factors such as intended use, risk level, mode of distribution, and degree of invasiveness within the human body. The classification of medical devices into these classes was based on factors such as the intended use, duration of contact with the body, and potential risks associated with the device.
Under these rules, medical devices were categorized into four classes:
Class A: Low-risk devices such as thermometers, blood pressure monitors, and stethoscopes.
- Class B: Low to moderate risk devices such as hypodermic needles, suction equipment, and surgical gloves.
- Class C: Moderate to high-risk devices such as syringes, orthopedic implants, and catheters
- Class D: High-risk devices such as cardiac stents, heart valves, and implantable defibrillators.
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