CDSCO Approval Service

The Indian medical regulatory system has become more stringent in recent years. In past, medical devices did not need to be approved at all, but that is not the case today. In India, there are about 30 device “families” that outline which specific medical devices need to be registered under Medical Devices Rules, 2017

Medical Device Rules, 2017 came into force in January 2018 and devices are regulated by the Central Drugs Standard Control Organization (CDSCO)

The Central Drugs Standard Control Organization (CDSCO) is a regulatory body

that lays down stringent standards that any drug, medical devices, diagnostic kits, cosmetics, biologicals and vaccines being introduced into the country must meet before being sold in the market.