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As per government rules, a medical device which itself or its predicate hasn’t yet been included in the medical devices list of CDSCO (Central Drugs Standard Control Organization) is considered a new medical device. Moreover, already registered devices vying to apply for new claims with respect to different implementation factors will also be treated as new devices.
Medical devices have been classified into A, B, C and D categories where the risk factor involved increases from A to D. Low-risk devices include equipment like thermometers whereas high-risk devices include pacemakers, heart valves and others. The devices are further classifed as surgical or non-surgical devices based upon their invasiveness. License for class A devices is easy to obtain as compared to class D devices.

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