Requirements for introducing Medical devices in India and US market-A comparative study of regulations

Medical devices are widely used in the healthcare sector and are manufactured by the pharmaceutical industry. The Government of India has periodically come out with certain guidelines, to be followed by the companies that are manufacturing medical devices. There are some challenges which have to do with the medical devices. Medical devices are designed by manufacturers in answer to the demands and expectations of doctors. They are then evaluated by doctors and are used in patients. Phase I trials are not possible for them as they cannot be tested on healthy volunteers. Adverse Drug Reactions are not detected in medical devices as easily as for medicines. There are no separate regulations (apart from Schedule M III of Drugs and Cosmetics Act) for Medical Devices in India before 2017. U.S. FDA has robust regulations for medical devices. If any company wants to market its medical device in the U.S.A, it should be proved to be substantially equivalent to a chosen predicate device that is already there in the market in the USA. This paper studies the current scenario in India and the USA regarding regulations concerning medical devices. It concludes that India cannot have a policy of “accept in India if it is accepted abroad”. Acceptance requirement should include certification from Notified Technical Bodies of India. India should have better connectivity between regulators and doctors as far as medical devices are concerned. A National Registry should be developed for each variety of Class D medical devices, such that “recall action”, if necessary, can be taken in a fast and systematic manner.