Regulatory Affairs and its Role in Medical Devices

Abstract

Regulatory affair is comparatively new profession which developed from the purpose of governments to protect public health by governing the quality, safety and efficacy of product within regulated industries. Regulatory affairs in the pharmaceutical industry play an important role as the pharmaceutical sector is rising very rapidly and there is want of regulatory affairs professionals to provide the current needs of industries for the global competition. Regulatory affairs professionals serve a critical function throughout a medical device’s product lifecycle-leading pre market strategy, drafting regulatory submissions, and ensuring post market compliance. The medical device industry plays a key role in the health care ecosystem by providing innovative solutions that improve patient outcomes. Every company seeks to innovate, whether through iterative updates to existing technology or by developing new devices that could offer a more effective treatment to a particular disease or condition. Many countries throughout the world have their own medical device regulations, however, and regulatory affairs is required to understand the difference in global regulatory requirements to ensure that new products can be marketed. The global regulatory landscape is always changing, so successful regulatory affairs teams follow global trains and are aware of new regulations or programs.