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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Getting a Cosmetic product registered and onto shelves in India is only half the job. Once a product is in the market, the Cosmetics Rules, 2020 place ongoing duties on manufacturers and...
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Although software intended for Medical purposes has been regulated in India since the implementation of MDR, 2017 Rules. CDSCO's Guidance Document on Medical Device Software (Doc No. CDSCO/MD/GD/MDSW/01/2026), issued on 21 July...
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India's Biological Regulatory landscape is at an inflection point. The country that pioneered affordable Biosimilar access, built one of the world's largest vaccine manufacturing ecosystems, and established the framework for recombinant Biological...
Regulatory Update
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A Recall is one of the few regulatory events where speed of response directly influences both patient safety outcomes and a company’s regulatory standing. Yet many manufacturers only consider their Recall process...
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