CDSCO Classifications of medical devices

CDCSO manages the affairs relating to the classification of medical devices. CDSCO classifies medical devices into four classes based on risk (A, B, C, and D) as per the regulation, which are as follows • Class A (Low Risk) • Class B (Low-Moderate Risk) • Class C (Moderate High Risk) • Class D (high Risk) • Class A (Low Risk) covers Absorbent cotton wools, surgical dressing, alcohol swabs etc. • Class B (Low-Moderate Risk) covers Thermometer, BP monitoring device, disinfectants etc. • Class C (Moderate High Risk) covers Implants, hemodialysis catheter etc. • Class D (high Risk) covers Angiographic guide wire, heart valve.


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