REGULATION OF MEDICAL DEVICES IN INDIA

LESSONS FROM USA’S FLAWS

Abstract

A vast range of medical devices exist in today’s world. Diagnosis devices to active implant devices have changed the health care system globally. However, medical devices need to be ensured of their safety especially if they are going to be implanted inside a human body. This is because active implantable devices’ extended lifecycle and prolonged contact with the patients. Medical devices need to be regulated before and after they enter the market. In the United States, medical devices are regulated by the Food and Drug Administration (FDA) through a pre-market approval. But the existing regulations in US form a big loophole which resulted in medical devices causing various health consequences including death. Medical device regulation is in a state of crisis in US for about three decades. In India, 20 % of medical device imports are from the US. The medical devices are being regulated only from 2018. This paper will analyse the medical device regulations in US and India. This paper will also focus on the failure of US laws to regulate medical devices in terms of safety. This paper will shed light into how India’s regulatory regime should not become like that of US.