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Wholesale Drug License

A wholesale drug license in Form 21B is a prerequisite for starting a business to sell or distribute drugs that include biologicals, in-vitro diagnostic kits, and medical devices. In India, the government...

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Why do we need import licenses for In-Vitro Diagnostics kits?

The medical devices market is growing at a fast pace along with the drug market despite all the challenges created by insufficient quality standards and other inconveniences. In India, medical devices are...

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Based on the provisions of the Medical Device Rules (MDR) -2017, the Drug Controller General of India (DCGI) has issued a classification of in-vitro diagnostic (IVD) medical devices used in various clinical fieldson 23 July 2021.

Based on the provisions of the Medical Device Rules (MDR) -2017, the Drug Controller General of India (DCGI) has issued a classification of in-vitro diagnostic (IVD) medical devices used in various clinical...

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COVID-19 Home Testing using Rapid Antigen Tests (RATs)

Rapid Antigen tests (RATs) are commonly used to diagnose respiratory pathogens, including influenza virus and SARS-CoV-2 virus. These tests have come to practical use in the diagnosis of the infection in the...

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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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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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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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