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Regulation/Guidelines

CDSCO Notifies To Update The Product Insert Of 4th Generation HIV In-Vitro Diagnostics Kit

NIB Noida is evaluating samples of in-vitro Diagnostics of 4th generation HIV kits for QC evaluation. While evaluating NIB, Noida noticed that many manufacturers of such Kits are not mentioning sensitivity for HIV P-24 antigen in the product insert. All the manufacturers or licensees are requested to update the product insert of these 4th generations HIV In-vitro diagnostic kits for inclusion of analytical sensitivity for HIV P-24 antigen so that there is no unnecessary delay in evaluation

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Regulation/Guidelines

CDSCO Releases Notice For The Online Application Of Certificates Of Notified Devices

The Central Drugs Standards Control Organization (CDSCO) streamlined the process for submission of application for the issue of free sale certificate, market standing certificate, and non-conviction certificate of notified medical devices in India.

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Regulation/Guidelines

CliniExperts Aided The Faster Approval Of Edinburgh Genetics Colloidal Gold Immunoassay And Whole Blood Collection COVID-19 Kits

CliniExperts successfully helped in getting approval of Edinburgh Genetics Colloidal Gold Immunoassay and Whole Blood Collection kits for testing COVID-19.The pre-approved COVID-19 testing kits by the Medicines and Healthcare Products Regulatory Agency (MHRA, UK) are now also approved by the Central Drugs Standard Control Organization (CDSCO) and validated by Indian Council of Medical Research (ICMR).

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Regulation/Guidelines

Regulation of 4 Medical Devices as Drugs by CDSCO: A new Notification

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 manufacturing licenses from the Central Licensing Authority or State Licensing Authority effectively from 1st January 2021.

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Regulation/Guidelines

Accelerated Approval Of RealCycler CORO-G Real Time PCR Kits By CliniExperts

RealCycler CORO-G Kits v.5.3 is Real-time PCR Test Kit, using Taqman-like hydrolysis probes technology, in combination with CHIC technology for the design of the internal amplification control. The kits allows the detection of Coronavirus SARS-CoV-2 and Sarbecovirus E gene RNA in clinical samples using realtime PCR.

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Regulation/Guidelines

Regulatory Approvals And Pathway For The Manufacture Of Ventilators Amid COVID-19

India is presently grappling with an acute shortage of ventilators in its fight against coronavirus. Ventilators do not fall under any regulated medical device category at present in India. Ventilators may also be coming under the regulated category soon. Once this happens the present regulatory pathways followed for ventilators will change and manufacturers or importers need to apply for manufacturing license or import license.

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Regulation/Guidelines

Notification For Ultrasound Equipment From CDSCO: Extension Of Timeline

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 1st day of November, 2021 for Ultrasound Equipment

Regulation/Guidelines

New Classifications Of Non-Notified Medical Devices And IVDs In India By CDSCO

CDSCO has classified almost 1866 medical devices and 80 IVDs. There are 24 categories of medical devices and 3 Categories of Non- Notified In-Vitro Diagnostic Medical Device proposed by CDSCO.

Regulation/Guidelines

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, and coveralls under Class A, and surgical drapes and non- notified in-vitro diagnostic (IVD) as Class B medical […]

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