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According to CDSCO guidelines, Replacement heart valve falls under Risk Class D under Cardiovascular category of Medical Devices. Intended use - A replacement heart valve is a device intended to perform the function of any of the heart's natural valves. This device includes valves constructed of prosthetic materials, biologic valves (e.g., porcine valves), or valves constructed of a combination of prosthetic and biologic materials.. This article will give you complete information about manufacturing Replacement heart valve