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.
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.
Regulation for all medical devices from October 1, says DCGI thehindu.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from thehindu.com Daily Mail and Mail on Sunday newspapers.
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.