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 EquipmentRead More
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 More
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.Read More
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.Read More
With the spurt in demand for infrared thermometers in India due to Coronavirus pandemic, the Government of India has eased down procedures at the custom level for easier import of the non-contact infrared thermometers by issuing no-objection certificate (NOC) for release of these medical devices.Read More
CDSCO released the notification for release of vaccines, IVDs and blood products (sampled 100% testing) from the ports after reviewing the documents, protocol, and certificate of release batch by the manufacturer and past satisfactory history of the product.Read More
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 […]
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.
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).