Risk Classification

Last Updated on February 22, 2022

  • Medical devices are classified into four classes: Class A, Class B, Class C and Class D
  • It is a risk-based classification. The determination of class is based on rules derived from the potential of a medical device to cause harm to a patient or user (i.e. the hazard it presents) and thereby on its intended use and the technology/ies it utilizes.  
  • Class A represents the lowest hazard and Class D the highest. Some of the examples are given below
ALow HazardTongue depressors/ disposable masks
BLow-moderate HazardHypodermic Needles / suction equipment
CModerate-high HazardLung ventilator / bone fixation plate
DHigh HazardHeart valves / implantable defibrillator


  • Detailed description on classification system of medical devices is provided in Schedule A of the Medical Devices Rules, 2017