It is possible to renew the product registration certificates and the current import licenses until July 31, 2018.

As of January 1, 2018, the new Regulation on Medical Devices and IVDs published by the Indian Regulatory Authority last year will be effective.

SUGAM, the online registration system, has already been updated according to the new legislative provisions.

Pending registration applications submitted in accordance with the previous “Drugs and Cosmetics Act” have been cleared from the system and must therefore be renewed in accordance with the new Regulation.

For more information:

http://www.cdsco.nic.in/writereaddata/Medical%20Device%20Rule%20gsr78E.pdf

http://cdsco.nic.in/writereaddata/Drugs&CosmeticAct.pdf