MD-15 Import License for Class A, B, C & D Devices
To legally import foreign medical devices into the Indian market, foreign manufacturers must secure an MD-15 Import License. Under CDSCO regulations, the foreign manufacturer must appoint an Indian Authorized Agent (holding a valid wholesale drug license and MD-42 registration) to submit regulatory dossiers on the SUGAM portal. We handle all aspects, including Power of Attorney (POA) registration, technical dossier compilations, and CDSCO central authority representation.
Key Benefits
- Assured legal market entry for global medical device brands
- Thorough review of foreign manufacturing sites to ensure CDSCO standard alignment
- Secure and streamlined handling of sensitive regulatory submissions
Recognized Standards
Our Methodology
Appoint Authorized Agent
Nominate a qualified Indian legal representative with wholesale credentials.
Dossier Preparation
Collect Free Sale Certificates, QMS audit reports, and technical dossiers.
Filing & Payment
File application for MD-15 via the SUGAM portal with government fees.
Review & Approval
Coordinate with CDSCO reviewers, resolve query requests, and download the MD-15.
Required Documents
Common Questions
Related Regulatory Insights
Need Assistance with MD-15 Import License for Class A, B, C & D Devices?
Our experts are ready to guide you through every step of the regulatory process. Let's discuss your project today.
Speak with a Consultant