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
Read MoreNew 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.
Read MoreCDSCO Releases Draft Regulatory Guidelines For The Development Of Vaccines In COVID-19 Pandemic
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.
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CDSCO codifies New Cosmetics Rules,2020
The Ministry of Health and Family Welfare (MoHFW) has notified the Cosmetics Rules, 2020 under the Drugs and Cosmetics Act, 1940. This move is to streamline all functions and bring effective compliance in the cosmetic sector of India. The notification came to separately codify and update the rules relating to import, manufacture, labeling, sale, and distribution of cosmetics in India, which were earlier set out under the Drugs and Cosmetics Rules, 1945.
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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, and coveralls under Class A, and surgical drapes and non- notified in-vitro diagnostic (IVD) as Class B medical […]
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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.
Read MoreRegulation/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.
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
CDSCO releases the timeline for Regularization of Rational Fixed Dose Combination in India
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