Abstract

REGULATORY APPROVAL PROCESS FOR MEDICAL DEVICES IN INDIA, USA & EUROPEAN UNION

Pushpa Bindu Nannepamu*, Tavva Naga Panindra Kumar, Pagadala Sai Ram, M. V. Nagabhushanam, G. Ramakrishna, Brahmaiah Bonthagarala, Y. Ratna Sindhu, Santosh Kumar Ch.

Abstract

Today millions of patients depend on medical device based treatment for the management and diagnose of several diseases. Quality and safety of device is depends upon the regulatory guidelines. Therefore a law containing adequate guidelines of rules and regulations are required for monitoring the entry of such devices into the use in public health. The regulations define requirements of medical device design, development and manufacture to ensure that products reaching market are safe and effective. Presently in India regulatory body CDSCO is governing regulation for regulation of devices which with time, amendment introducing in the law will provide safety assurance to public health. The United States has long had the world’s most successful medical device (or med tech) industry, with the European Union (EU) serving as its largest export market. The trading bloc’s reputation for relatively timely market approvals has long benefited these U.S. manufacturers. However, the EU’s soon-to-be- implemented Medical Device Regulation (MDR)—an overhaul of the previous med tech regulatory regime—may present a number of obstacles for U.S. and other med tech firms that could limit their access to a critical market. The present review discuss about the classification of medical devices and regulations aspects in India, USA and European Union.

Keywords: Medical classification, Regulatory, License, Marketing, European Union (EU).