In the dynamic and highly regulated world of medical devices, understanding and meeting regulatory expectations is crucial, especially for Class III medical devices. These high-risk devices, which include prosthetic heart valves, absorbable surgical sutures, and hip prostheses, play vital roles in patient care. In this article, I aim to shed light on what regulators, particularly the Therapeutic Goods Administration (TGA) in Australia, look for in Class III medical devices. Drawing from my years of experience as a regulatory affairs manager specializing in medical devices and in vitro diagnostics (IVDs), I will guide you through the key aspects of regulatory compliance. Understanding Class III Medical Devices Class III medical devices are the most stringently regulated due to the significant risk they pose to patient health and safety. They often sustain or support life, are implanted in the body, or present a potential for significant risk of illness or injury. Examples include: Pros ...
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