Complete Procedure to Meet the CDSCO License Mandate of Class C & D Non-Notified Medical Devices
Overview of the CDSCO License Mandate The Central Drugs Standard Control Organisation (CDSCO) is the regulatory body that manages medical device registration in India under the Ministry of Health & Family Welfare. The main aim of CDSCO is to ensure that medical devices are...
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Presently, the Indian market for medical devices is largely unregulated. Medical devices are freely imported into India. Only certain products require medical device registration in India. Over the years, there have...
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The clinical trial of Medical Device is different in nature as compared to that of Drugs or vaccines. In case of Medical Device, they do not conduct Phase I clinical trial to...
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By Jill Hartzler Warner, J.D. The U.S. Congress and the Food and Drug Administration have long focused on bringing new therapies to patients with rare diseases, including children. Two years...
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File No. 29/Misc/3/2012-DC (169) 8th Jan 2013 Medical devices which are notified under the provisions of Drugs and Cosmetics Act 1940 requires Registration certificate in Form 41 and Import Licence in Form...