Medical device makers may get more time to secure licences
medical devices such as ventilators, nebulisers, and x-ray equipment to continue production for “a limited period” amid a delay in issuing new regulatory licences, a senior official said.
With the Central Drugs Standard Organisation (CDSCO) missing the October 1 deadline to provide licences to them, it is likely that those manufacturers that have already applied may get an extension for a limited period, the official said.
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Offering CollegeCourseWebsiteIIM KozhikodeIIMK Healthcare Management & Analytics ProgrammeVisit“Those who have not applied (for licence) will not get any extension,” he added.
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.
As reported by ET on Wednesday, several manufacturers said they had filed for a licence in July but were still awaiting audits, on the basis of which they will be given licences.
Medical devices are classified based on the risks they pose.
