Indian Regulators Launching Mandatory Online Medical Device Registration Platform
India’s Central Drugs Standard Control Organization (CDSCO), responsible for overseeing the country’s medical device market, has implemented an online portal for submission of registration certificates and import licenses to facilitate faster commercialization pathways.
Update February 26 2016: Mandatory online registration with the CDSCO will apply only to notified medical devices.
Through the portal, India Authorized Agents can now submit Form-41 registration certificates and Form-10 import licenses to the CDSCO’s Import & Registration Division, as well as track the progress of their manufacturing clients’ registration applications following online submission.
According to Emergo consultants in India, the platform will go fully live March 1, 2016, and by April 1 online CDSCO registration will become mandatory.
Emergo’s offices in New Delhi and Secunderabad will continue monitoring the situation to determine how the online CDSCO submission system will impact ease and speed of Indian market registration for foreign manufacturers.