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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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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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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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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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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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Regulatory Approvals and Pathway for the Manufacture of Ventilators amid COVID-19

Cases of Novel Coronavirus (COVID-19) infection are rising every day across the world. Acute respiratory failure is one of the commonest causes of death among COVID-19 patients as this infection can inflame...

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