Regulation of medical devices set for overhaul to improve quality, safety

Health ministry has issued a draft notification to define all medical devices under Drugs and Cosmetics Act

The regulation of medical devices in the country is set for an overhaul. The government plans to bring all medical devices under the jurisdiction of the Central Drugs Standard Control Organisation (CDSCO) with an aim to improve their quality as well as safety. 

Sources said this would require a complete revamp of the CDSCO, with a new vertical to monitor devices and conduct fresh recruitment. Besides, plans are afoot to have a separate statutory body on the lines of the Food Safety and Standards Authority of India (FSSAI) for the regulation of medical devices. In that case, devices will be out