Importer Services in India

The key responsibilities of an Indian Authorized Agent (IAA) for importing medical devices into India are:

1. Submit the import license application (MD-14) for each manufacturing site, which requires a comprehensive Device Master File (DMF) for each product.

2. Liaise with the Central Drugs Standard Control Organization (CDSCO) to provide any additional information requested until approval is granted. 

3. Submit a test license application for import of devices intended for testing, evaluation, and clinical investigations.

4. Handle post-approval changes and endorsement applications.

5. Conduct post-marketing surveillance activities.

6. Notify the CDSCO within 15 days of any adverse reactions, recalls, or regulatory restrictions.

7. Obtain prior approval from the CDSCO before implementing any major changes.

8. Notify the CDSCO within 30 days of any minor changes.

9. Inform the CDSCO within 30 days of any change in the constitution of the manufacturer or the IAA.

10. Ensure medical devices comply with Indian labeling and packaging standards.

11. Collaborate with the manufacturer to understand the products and regulatory needs and assist in navigating the complex Indian regulatory landscape.

12. Provide the clearing agent with key documents like commercial invoice, batch release certificate, packing list, airway bill, end user certificate, etc. for customs clearance.