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
Read MoreThe 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.
Read MoreAfter 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 alcohol-based hand rub for 20-30 seconds when hands are not dirty.
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To put regulations on this matter, Central Drugs Standard Control Organisation (CDSCO) made a list of 294 FDCs, and directions are given to all State/UT Drug Controllers of India to withdraw 294 FDCs from the licensed market the consent of DCGI. Court then got it to stay order in favour of the Manufacturers Association
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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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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.
Read MoreCDSCO 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.
The Central Drugs Standard Control Organisation (CDSCO) released draft guidelines for developing vaccines in the grave situation of COVID-19, taking it as a special case. The Central Drug Authority came with the guidelines considering the Drug and Cosmetics Rules, 1940 and New Drugs and Clinical Trials Rules, 2019, and the international perspectives of World Health Organization (WHO), United States Food and Drug Administration (USFDA), European Medicines Agency (EMA) guidelines, and other applicable guidelines of 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 […]
