Regulatory aspects of medical devices in India

International Journal of Drug Delivery

View Publication Info
 
 
Field Value
 
Title Regulatory aspects of medical devices in India
 
Creator Targhotra, Monika; Delhi Pharmaceutical Science and Research University, Pushp Vihar, Sector-3 MB Road, New Delhi-110017, India
Aggarwal, Geeta; Delhi Pharmaceutical Science and Research University, Pushp Vihar, Sector-3 MB Road, New Delhi-110017, India
Popli, Harvinder; Delhi Pharmaceutical Science and Research University Pushp Vihar, Sector-3 MB Road, New Delhi-110017
Gupta, Madhu; Delhi Pharmaceutical Science and Research University Pushp Vihar, Sector-3 MB Road, New Delhi-110017
 
Subject Pharmaceutical Sciences; Pharmaceutics; Drug Delivery
Medical devices, classification, regulatory, license, marketing etc.
 
Description 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. Medical device manufacturing in India should be taken seriously due to large population and the potential severity of the consequences of introducing inferior and unsafe products to the market-place. 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. This review provides a study on different regulatory aspects of medical device implemented in India. The present review discuss about the classification of medical devices and regulations aspects in India.
 
Publisher Advanced Research Journals
 
Contributor
 
Date 2017-10-06
 
Type info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion

 
Format application/pdf
 
Identifier http://www.arjournals.org/index.php/ijdd/article/view/2147
10.5138/09750215.2147
 
Source International Journal of Drug Delivery; Vol 9, No 2 (2017): International Journal of Drug Delivery; 18-27
0975-0215
 
Language eng
 
Relation http://www.arjournals.org/index.php/ijdd/article/view/2147/pdf
 
Rights Copyright (c) 2017 Monika Targhotra, Geeta Aggarwal, Harvinder Popli, Madhu Gupta
http://creativecommons.org/licenses/by-nc-nd/4.0
 

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