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Class III Medical Device

Meaning

A Class III Medical Device represents the highest regulatory category for medical products, encompassing devices that sustain or support human life, are of substantial importance in preventing health impairment, or present a potential, unreasonable risk of illness or injury. These devices typically require Premarket Approval (PMA) from regulatory bodies, demanding rigorous scientific evidence of safety and effectiveness before they can be marketed. Examples often include implantable pacemakers, heart valves, and certain complex diagnostic systems critical for patient care. The high-risk nature necessitates the most stringent regulatory oversight.