Starting from March 2016, the Indian CDSCO (Central Drugs Standard Control Organization) stated the obligation to register also medical and IVD devices in Sugam online portal. This portal is active for drugs since 2015.

In case of missing registration within March 15, 2016, the device shall not be placed on the Indian market.

A transition period from hard-copy to online registration has been established from April 1, 2016 and lasted four weeks. So now the portal is the only active and official tool to register Medical Devices and IVDDs.


For further information: