Medical device makers may get more time to secure licences

NEW DELHI: The federal government might permit producers of high-risk medical gadgets resembling ventilators, nebulisers, and x-ray tools to proceed manufacturing for “a restricted interval” amid a delay in issuing new regulatory licences, a senior official stated.

With the Central Medication Customary Organisation (CDSCO) lacking the October 1 deadline to offer licences to them, it’s probably that these producers which have already utilized might get an extension for a restricted interval, the official stated.

“Those that haven’t utilized (for licence) won’t get any extension,” he added.

October 1 was the deadline for bringing ‘class C’ and ‘class D’ medical gadgets – indicating ‘reasonable’ and ‘excessive’ threat – below CDSCO regulation as a part of a authorities choice to make it obligatory for all imported and domestically manufactured medical gadgets bought within the nation to be licensed by the drug regulator earlier than they enter the market to make sure high quality.

As reported by ET on Wednesday, a number of producers stated that they had filed for a licence in July however have been nonetheless awaiting audits, on the premise of which they are going to be given licences.

Medical gadgets are categorized primarily based on the dangers they pose.