Journal of Biomedical Engineering and Medical Devices
Open Access
ISSN: 2475-7586
ISSN: 2475-7586
Dr, M. Pharm Drug Regulatory Affairs, Department of Pharmacy, Acharya & BM Reddy College of Pharmacy, Bengaluru-560107, India
Research Article
Comparative Regulatory Insight for Medical Device in India and EU
Author(s): Nitika Agrahari*, Divakar Goli and 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 co.. View More»
DOI:
10.35248/2475-7586.22.7.231