Medical devices in India are categorized into A, B, C and D classes based upon the associated risk and Indian regulatory bodies have defined procedures for license applications. This includes rules for the import of medical devices.
We, at Metina, support clients in the application and licensing of Medical devices in India in the following ways:
Identifying the category of medical device and define regulatory pathway through State Licensing Authority or Central Licensing Authority
Acting as authorized Indian agent to apply for the license through the SUGAM portal
Support for Clinical Investigation Permission for new medical device in India
Assist in all documentation pertaining to Import license, test license, manufacturing license as applicable
Query resolution to support timely approvals
Prospecting and identification of marketing & distribution partners in India