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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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CDSCO Orders Regulation of CT Scan Equipment, All Implantable Devices, Medical Equipment As Drugs

Regulations for the import or manufacture of medical devices The Ministry of Health & Family Welfare, Government of India, has notified the list of equipment or devices which will be regulated as...

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update the product insert of 4th Generation HIV In-vitro Diagnostics kit

CDSCO has designated the National Institute of Biologicals (NIB), Noida, as Central Medical Device Testing Laboratory as per rule 19 of Medical Device Rules, 2017 released on 1st June 2018.NIB performs tests...

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CDSCO codifies New Cosmetics Rules,2020

The Ministry of Health and Family Welfare (MoHFW) has notified the Cosmetics Rules, 2020 under the Drugs and Cosmetics Act, 1940. This move is to streamline all functions and bring effective compliance...

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Regulation of 4 Medical Devices as Drugs

CDSCO has notified four medical devices, i.e., nebulizer, blood pressure monitoring devices, digital thermometer, and glucometer as drugs. The importers and manufacturers of these 4 medical devices need to take import and...

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Notification for Ultrasound equipment

The Ministry of Health and Family Welfare has recently come up with a release of notification dated 21st October 2020 to extend the timeline from 1st day of November, 2020” to the...

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CDSCO releases the timeline for Regularization of Rational Fixed Dose Combination in India

Indian pharma market is flooded with irrational Fixed Dose Combination (FDCs) and is an important topic for critical and scientific analysis. The country needs some regulatory laws for FDCs after analysing whether...

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New classifications of non-notified medical devices and IVDs in India by CDSCO

The Central Drugs Standard Control Organisation (CDSCO) has released two notices on September 3, 2020, including the classification of non-notified medical devices and in-vitro diagnostic devices (IVDs). To simplify the classification process...

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CDSCO releases Draft Regulatory Guidelines for the development of vaccines in COVID-19 Pandemic

Coronavirus still poses a potential threat to the global population, but no vaccines protect the body against the virus, causing COVID-19. The coronavirus spreads quickly, and majority of the world's population is...

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