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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Introduction Stem cell therapy represents one of the most scientifically promising and regulatorily complex frontiers in modern medicine. India's stem cell regulatory landscape presents both genuine opportunity and significant compliance risk. The...
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Three Regulatory Bodies, One Physical Label A Cosmetic label entering India is reviewed — directly or through market surveillance — against the requirements of three separate regulatory frameworks: CDSCO's Cosmetics Rules 2020...
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India's Medical Devices Rules, 2017 (MDR 2017) has a distinct regulatory pathway for Devices classified as New Medical Devices — a category that carries additional scrutiny, documentation requirements, and in many cases,...
Regulatory Update
Regulatory Update
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The Common Technical Document (CTD) is the universal language of Pharmaceutical and Biological registration. Most global regulatory agencies, including the USFDA, EMA and PMDA accept the ICH CTD format with regional Module...
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