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Medical device makers may get more time to secure licences

October 1 was the deadline for bringing ‘class C and ‘class D medical devices – indicating ‘moderate and ‘high risk – under CDSCO regulation as part of a government decision to make it mandatory for all imported and locally manufactured medical devices sold in the country to be certified by the drug regulator before they enter the market to ensure quality. ....

Offering College , Central Drugs Standard Organisation , Healthcare Management Analytics Programme , Healthcare Expertise , Medical Devices , X Ray Equipment ,

medical devices: Many high-risk medical device manufacturers stop production

Earlier this year, the Central Drugs Standard Organisation (CDSCO) had set the October 1 deadline for bringing class C and class D medical devices under regulation to control quality. According to the new regulation, medical devices belonging to these categories, such as ventilators, imagining equipment, oxygen therapy equipment, nebulisers, x-ray equipment, surgical robots and oncology treatment linear accelerator, can t be sold from October 1 without a manufacturing licence. ....

Rajiv Nath , Association Of Indian Medical Devices Industry , Central Drugs Standard Organisation , Offering College , Healthcare Expertise , Indian Medical Devices , Medical Devices , Supply Chain , High Risk Medical Devices , Manufacturing Licence ,

Regulation for all medical devices from October 1, says DCGI

Regulation for all medical devices from October 1, says DCGI
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CDSCO Approves Shelf Life Of COVID-19 Vaccines

Responding to a question on the shelf life of Covid vaccines approved in the country and their active period among the vaccinated people, Mandaviya, in a written reply, said the vaccines were developed very recently, therefore, scientific evidence regarding the duration of protection is still evolving globally. ....

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CDSO approves shelf life of Covid vaccines

CDSO has approved the shelf life of Covaxin to 12 months, Covishield to nine months, and ZyCoV-D to six months from the date of manufacture ....

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