- A medical device is an instrument, apparatus, implant, in vitro reagent, or related article that is used to diagnose, prevent, or treat disease or other conditions, and does not achieve its purposes through chemical action within or on the body (which would make it a drug). Whereas medicinal products (also called pharmaceuticals) achieve their principal action by pharmacological, metabolic or immunological means, medical devices act by other means like physical, mechanical, or thermal means.
Class I- devices that present minimal harm to the user.
Class II-devices subjected to special controls, mandatory performance standards and post
marketing surveillance.
Class III-devices generally requiring premarket approval and a scientific review to ensure the
device’s safety and effectiveness.
