Bridging the gap: a paradigm shift in medical device regulations in India.

Abstract

India is among the top 20 international markets for medical devices. With increasing economic growth, rising life expectancy, and rapid technological advancements, the healthcare needs of the population have surged. This is particularly evident with the rise in chronic diseases, growing healthcare awareness, and the growing demand for personalized care and treatment. Medical devices, which encompass a wide range of machines, instruments, apparatus, and even software, play a vital role in diagnos