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
| CLASS | LEVEL | DEVICE EXAMPLES |
| A | Low Hazard | Tongue depressors/ disposable masks |
| B | Low-moderate Hazard | Hypodermic Needles / suction equipment |
| C | Moderate-high Hazard | Lung ventilator / bone fixation plate |
| D | High Hazard | Heart valves / implantable defibrillator |
- Detailed description on classification system of medical devices is provided in Schedule A of the Medical Devices Rules, 2017