How to get medical device import license in India?

To get a medical device import license in India, you must follow the CDSCO registration process under the Medical Device Rules, 2017.
First, determine the classification of the medical device (Class A, B, C, or D). Next, if you are a foreign manufacturer, appoint a licensed Indian Authorized Agent. Then prepare all required documents including Power of Attorney, ISO 13485 certificate, Free Sale Certificate, Device Master File, and labeling compliance documents.
After documentation is complete, submit Form MD-14 through the CDSCO SUGAM portal along with the prescribed government fees. CDSCO will review the application and may raise technical queries. Once approved, CDSCO issues the MD-15 import license, which allows legal import and sale of the medical device in India.
If you require professional assistance with documentation preparation or MD-15 filing, you may explore our medical device import license consultancy services in India.