DefinePK

Abstract

Technological advancements in medical devices have drastically transformed the healthcare sector, significantly improving patient outcomes and efficiency. Innovations like wearable monitor’s robotic surgery, AI diagnostics, Smart implants, and nanotechnology are enhancing treatment accuracy and patient comfort, making healthcare more effective, accessible, and patient-centered. The rapid growth of the medical device industry is driven by factors such as aging, technological advancements, rise in chronic diseases. The Increasing demand for devices to manage conditions like diabetes and heart disease is shifting focus towards preventive care and early detection. Expanding healthcare access, higher spending capacity, fast regulatory approvals, and evolving reimbursement policies are fueling this growth, with innovations like minimally invasive surgeries, wearable devices, and investments in medical startups further accelerating the sector. These advancements in medical Technology may lead to bring about legal challenges, highlighting the inadequacy of existing laws to address emerging Issues. In India, the only existing law is the Drugs and Cosmetics Act, 1940, which is outdated and unable to address the new challenges posed by the emerging medical devices. To tackle these issues, a Draft of the New Drugs, Medical Devices and Cosmetics bill,2022 has been proposed. This paper tries to critically analyze the new changes introduced in the new drugs, Medical Devices and Cosmetics Bill, 2022, and also discuss the associated Issues and challenges.