No, foreign manufacturers cannot directly apply for a CDSCO medical device import license in India without an Indian Authorized Agent for Medical Devices. Under the Medical Device Rules, 2017, overseas manufacturers must appoint an authorized representative or importer in India to handle the MD14 application and CDSCO communication process.
The Indian Authorized Agent acts as the official point of contact between CDSCO and the foreign manufacturer. Moreover, the agent helps manage regulatory coordination, document submission, and query responses during the approval process.
Foreign manufacturers usually require:
1. Device classification support
2. MD14 application filing
3. Documentation review
4. CDSCO query handling
5. MD15 import license approval support
Therefore, many overseas companies prefer to work with a professional Medical Device Import License Consultant in India to simplify the process and avoid delays.
Can Foreign Manufacturers Apply Directly for MD-14 in India?
Can Foreign Manufacturers Apply Directly for CDSCO Medical Device Import License in India?