The Central Drugs Standard Control Organization in its Notification dated 15th November 2019 has issued an Office Memorandum for processing of application for product approved as medical device in the country of origin and not covered under the medical devices notified in the country.
CDSCO has received application for grant of permission to import various products falling under the definition of drugs/new drugs but they are approved as medical device in the country of origin therefore in order to streamline the process, it has been decided that processing of such applications will be done by New Drugs division or Import division of CDSCO and the applications should be submitted through SUGAM Portal. However the CMC, safety and efficacy data etc. of the product should be submitted as per the checklist applicable for medical devices.
Click here to read the Notification .
