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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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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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Classification of non-notified Medical Devices : A major move by CDSCO

On 3rd September, 2020, CDSCO released a draft classification for non-notified Medical devices. The Ministry of Health and Family Welfare (MoHFW) is going to classify non-notified medical devices like gowns, adhesive drapes,...

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CDSCO releases notice for the online application of certificates of Notified Devices

Presently in India, only notified medical devices are regulated as Drugs under the Drugs and Cosmetics Act 1940 and Rules in 1945. The Central Drugs Standards Control Organization (CDSCO) streamlined the process...

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Relaxation of Drug License for Selling and Stocking Hand Sanitizers

After the outbreak of COVID-19, the World Health Organization (WHO) has said that hand hygiene is important to prevent the virus's spread. Hand hygiene guidelines of WHO recommends the use of an...

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CliniExperts aided the faster approval of Edinburgh Genetics Colloidal Gold Immunoassay and Whole Blood Collection COVID-19 kits

India is touching its peak in numbers of COVID-19 cases daily, making it critical to increase testing rapidly. Diagnostic companies worldwide are constantly manufacturing COVID-19 kits for mass testing and further prevention...

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Accelerated Approval of RealCycler CORO-G Real Time PCR Kits by CliniExperts

The rapid spread and alarming increase in the number of coronavirus disease 19 (COVID-19) cases caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in the community is increasing the burden in...

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CDSCO notified information on Convalescent Plasma in COVID-19

A growing number of research centres, hospitals are investigating antibody testing and blood- plasma therapy as a way to fight the new coronavirus in sick patients. People who survive an infectious disease...

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