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CDSCO releases draft guidance document on stability studies of IVD Medical Devices

AuroBlog - Aurous Healthcare Clinical Trials blog

The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document on stability studies of In-vitro Diagnostic Medical Device (IVDMD) to aid manufacturers in the preparation of premarket review documents for the import or manufacturing license applications.

In-Vitro 172
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DCGI emphasises need for sample test for standards for medical devices and IVDs

AuroBlog - Aurous Healthcare Clinical Trials blog

Drugs Controller General of India (DCGI) Dr Rajeev Singh Raghuvanshi has emphasised that the medical devices and in-vitro diagnostics (IVD) sold in the county should be tested for the standards prescribed by the Bureau of Indian Standards (BIS) for its quality and performance in the country.

In-Vitro 117
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CDSCO calls for timely reporting of adverse events related to medical devices to MvPI

AuroBlog - Aurous Healthcare Clinical Trials blog

All the medical devices including in-vitro diagnostic medical devices have come under the regulation […]

In-Vitro 157
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DCGI adds IVD devices for diagnosis of Covid-19, RNA & DNA extraction kits in Class C risk category under MDR-2017

AuroBlog - Aurous Healthcare Clinical Trials blog

The Drug Controller General of India (DCGI) has added in-vitro diagnostic (IVD) medical devices including those for diagnosis of Covid-19, ribonucleic acid (RNA) and deoxyribonucleic acid (DNA) extraction kits, among others into the Class C risk category under the Medical Devices Rules (MDR), 2017.

RNA 163
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Keeping tabs on Covid-19: BetterLife embraces virtual clinical trials and Novan shares positive results from in vitro antiviral technology against SARS-CoV-2

The Pharma Data

With many nationwide and regional lockdowns coming into force, virtual clinical trials are proving to be an effective way to monitor patients remotely. BetterLife conducts patient centric study via a fully remote clinical trial. In vitro antiviral technology proves effective against SARS-CoV-2 in human airway infection model.

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Requirements to Conduct First-in-Human (FIH) Clinical Trials for Biopharmaceuticals

ProRelix Research

The transition of a drug, medical device, or biopharmaceutical from the laboratory bench to bedside involves a long series of steps starting from drug discovery, computational chemistry, in vitro and […] The post Requirements to Conduct First-in-Human (FIH) Clinical Trials for Biopharmaceuticals appeared first on ProRelix Research.

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First hybrid gene therapy shows early promise in treating long QT syndrome

Scienmag

— In a new study published in Circulation, Mayo Clinic researchers provide the first preclinical, proof-of-concept study for hybrid gene therapy in long QT syndrome, a potentially lethal heart rhythm condition. ROCHESTER, Minn.