Beyond FDA: Securing Your Medical Device Import License in India

Medical Device Global Market Access · Aug 5, 2025 · 3m

This episode demystifies the process for medical device manufacturers who have U.S. FDA approval and are targeting the Indian market. We clarify that while FDA registration is beneficial, it does not replace the mandatory import license from India's Central Drugs Standard Control Organization (CDSCO). We outline the essential steps, including appointing an Authorized Indian Agent, understanding India's risk-based device classification, and preparing the required Device and Plant Master Files for a successful submission. Key Questions: • Does having U.S. FDA approval mean you can automatically…