Regulation for Medical Devices in India

Abstract

In the era of competitive use of medical devices, stringent regulatory standards should be followed to ensure that the devices are safe, well studied and have minimum adverse reactions. Recently introduced guidelines and the amendment in the law will provide adequate guidance for both the manufacturers and competent authorities to manage cases efficiently and appropriately. India has emerged as one of the leaders in pharmaceutical sector. Like many other amendments in Drugs and Cosmetics Act that have boosted the global confidence in pharmaceutical sector in India, guidelines for devices will encourage the much needed research for devices in medical field. Pharmacy personnel can certainly play an important role in the regulation of medical devices. Safety, risks, effectiveness and performance of the medical devices need to be well established and regulated properly. It is necessary that the guidelines should be implemented and regulated effectively for a productive outcome to upgrade the health status of individuals.