Zeitschrift für Biomedizintechnik und Medizingeräte
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Comparative Regulatory Insight for Medical Device in India and EU

Nitika Agrahari*, Divakar Goli, Shantha Kumar GS

Medical Device is an emerging market. The specific areas of application and extent of usage of medical devices is ever increasing throughout the world and becoming more and more sophisticated with every passing year. Regulations of Medical Devices vary from country to country. European Medical Agency (EMA) regulates medical devices in EU while the Central Drug Standard Control Organization (CDSCO) is its counterpart in India. Recently introduced guidelines and various amendments provide adequate guidance for the manufacturers, distributors and competent authorities to manage various activities and regulatory processes in an efficient manner. They perform a gap analysis of various regulatory frameworks of their business interests in order to thoroughly understand the inputs required for regulatory approvals across geographic territories. This research highlights comparative study of current regulations in India and EU, pertaining to applications for medical device registration certificates and medical device manufacturing/importation licenses. The recommendations are to be expected to implemented and regulated properly with effective outcome.