Regulatory Standards for medical devices has a 3 class classification system that are class 1,2 and 3. They are classified on the basis of risk that is present while using them on a patient. As the class increases the risk of the device increases.

Class 1 medical devices have lowest to moderate risk. 47% of medical devices fall underclass 1 and 95% of these are exempted from the regulatory process. Manual stethoscope, bandages are examples of class 1 medical devices.

Class 2 medical device have moderate to high risk. 43% of medical devices fall under this class. Wheelchair, pregnancy test kit are some examples of class 2 devices.

Class 3 medical devices have highest risk of all medical devices. 10% of medical devices fall under this class. Implantable pacemaker is an example of class 3 medical devices