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Abstract

Current status of the regulation for medical devices

Author(s): Anuja R Shah, RK Goyal
L. M. College of Pharmacy, P.O. Box 4011, Navrangpura, Ahmedabad-380 009, India

Correspondence Address:
R K Goyal L. M. College of Pharmacy, P.O. Box 4011, Navrangpura, Ahmedabad-380 009 India [email protected]


In the light of escalating use of medical devices, stringent regulatory standards are required to ensure that the devices are safe, well studied and have least 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 industry. Like many other amendments in Drugs and Cosmetics Act that have boosted the global confidence in pharmaceutical industry in India, guidelines for devices will encourage the much needed research in medical devices. Pharmacy personnel can certainly play an important role in the regulation of medical devices. Safety, risks, effectiveness and performance of the medial devices need to be well established and regulated properly. It is hoped that the guidelines are implemented and regulated properly with effective outcome.



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