Medical Device Import Licence (MD-14 / MD-15)
Indian importers, authorised agents and foreign manufacturers seeking to import medical devices into India are required to obtain the applicable import licence (MD-14 or MD-15) from CDSCO. We assist with regulatory pathway determination, documentation, CDSCO application filing and regulatory query management.
Start a ConversationWhat's Included
- Regulatory pathway determination (MD-14 / MD-15)
- Documentation preparation and review
- CDSCO application filing and submission
- Regulatory query and follow-up management
- Licence renewal support
How we work with you.
Regulatory Assessment
Determining the applicable regulatory pathway and CDSCO requirements for your medical device.
Documentation
Preparing technical and supporting documentation for the import licence application.
CDSCO Filing
Filing the application with CDSCO and managing queries and follow-up.
Licence & Compliance
Obtaining the import licence and guiding on import and distribution compliance.
Frequently Asked Questions
What is the difference between MD-14 and MD-15?+
MD-14 is the import licence for Class A and Class B medical devices, while MD-15 is for Class C and Class D medical devices. The applicable form depends on the risk classification of your device under the Medical Devices Rules, 2017.
Ready to get started?
Tell us about your situation and our team will determine the next step.
Start a Conversation