Is Indian Authorized Agent Mandatory for CDSCO?

Yes. An Indian Authorized Agent is mandatory for foreign manufacturers applying for a CDSCO medical device import license in India.
Under the Medical Device Rules, 2017, foreign manufacturers cannot directly submit an application to CDSCO. They must appoint a licensed Indian Authorized Agent who acts as the official regulatory representative in India.
The Authorized Agent is responsible for:
Submitting Form MD-14 application
Communicating with CDSCO during technical review
Responding to regulatory queries
Maintaining post-approval compliance
Holding a valid wholesale drug license
Managing retention fee requirements
Without appointing an Authorized Agent, CDSCO will not process the MD15 import license application.
Therefore, selecting a qualified regulatory partner is critical for smooth approval and long-term compliance in India.
If you are a foreign medical device manufacturer planning to export to India, you may explore our Indian Authorized Agent and CDSCO Medical Device import license services for complete regulatory support.