Classifications of Medical Devices in India - CDSCO
Posted: 02 Apr 2021, 20:21
The CDSCO classifications of medical devices govern alongside the regulatory approval and registration by the CDSCO is under the DCGI.
CDSCO classification for medical devices has a set of risk classifications for 12 products planned for notification and guideline as medical devices.
CDSCO classification for medical devices Risk-based Classifications Medical Devices are generally based on risks; the actual risk-based classification of the medical device depends upon its intended use and purpose.
Low Risk –Class A –(Absorbent cotton wools, surgical dressing, alcohol swabs etc)
Low Moderate Risk –Class B–(Thermometer, BP monitoring device, disinfectants etc)
Moderate High Risk –Class C–(Implants, hemodialysis catheter etc)
High risk –Class D–(Angiographic guide wire, heart valve)
CDSCO classification for medical devices has a set of risk classifications for 12 products planned for notification and guideline as medical devices.
CDSCO classification for medical devices Risk-based Classifications Medical Devices are generally based on risks; the actual risk-based classification of the medical device depends upon its intended use and purpose.
Low Risk –Class A –(Absorbent cotton wools, surgical dressing, alcohol swabs etc)
Low Moderate Risk –Class B–(Thermometer, BP monitoring device, disinfectants etc)
Moderate High Risk –Class C–(Implants, hemodialysis catheter etc)
High risk –Class D–(Angiographic guide wire, heart valve)