What is Import License (MD 15): Class A & B
Form MD-15 is an import License granted by CDSCO under the Medical Devices Rules, 2017 that permits authorized importers to legally import, sell, and distribute Class A and Class B medical devices in India. The application is submitted through Form MD-14 by an Authorized Indian Agent on behalf of the foreign manufacturer. This License ensures that imported medical devices comply with applicable safety, quality, performance, and labelling requirements prescribed under MDR 2017. MD-15 acts as a mandatory regulatory approval for lawful market entry and commercial distribution of imported medical devices in India.
When Do You Need CDSCO Import Support?
Support for importing medical devices into India, preparing documentation, and managing CDSCO compliance before market entry.
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Importing Class A or Class B medical devices into India
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Launching a foreign-manufactured device in the Indian market
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Appointing an authorized Indian agent/importer
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Expanding product portfolio with new imported devices
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Ensuring compliance before commercial distribution and sale
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Complex documentation requirements
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Device classification and regulatory pathway confusion
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Coordination with foreign manufacturers
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Technical documentation gaps (STED/DMF)
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CDSCO query handling delays
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Evolving CDSCO regulatory requirements and compliance updates
Our Approach and What You Will Get
End-to-end support for medical device import licensing, documentation, and CDSCO coordination in India.
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Regulatory strategy and classification assessment as per Medical Devices Rules 2017
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Appointment and compliance setup of Authorized Indian Agent
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End-to-end documentation (STED, FSC, QMS, labelling)
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Dossier preparation and submission on CDSCO portal
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Coordination with Central Drugs Standard Control Organization
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Query management and fast-track approval strategy
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Post-approval compliance and lifecycle support
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Complete documentation support (STED, Plant Master File, labelling)
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Regulatory pathway clarity and strategy report
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Authorized Agent compliance setup
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End-to-end MD-14 application filing
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Query management and efficient regulatory coordination
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MD-15 Import License approval support
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Ongoing regulatory compliance guidance
Why Choose Tacit Medtek and Case Example
End-to-end regulatory support for medical device imports, MD-15 approvals, and CDSCO coordination in India.
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Deep knowledge of CDSCO rules for medical device imports
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Strong grasp of Medical Devices Rules, 2017
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End-to-end support—from documentation to final approval
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Help with Authorized Agent appointment and compliance setup
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Accurate and compliance-focused regulatory submissions
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Strategic regulatory support for efficient approvals
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Support with application submission and regulatory coordination
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Proactive handling of queries and compliance needs
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Dedicated client support with timely communication
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A trusted long-term partner for seamless MD-15 approvals
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Challenge: A distributor planned to import a Class B diagnostic device from a foreign manufacturer but faced delays due to incomplete documentation and lack of clarity on appointing an authorized Indian agent. They were also unsure about post-approval compliance requirements.
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Our Approach: Spotted gaps in existing documents and fixed them.
Helped appoint and document the Authorized Indian Agent.
Reviewed Free Sale Certificate, ISO certification, and technical dossier for compliance.
Prepared and submitted a complete MD-15 application with accurate labelling and device details.
Coordinated with CDSCO and answered queries on time. -
Outcome: The client successfully obtained the MD-15 Import License after completion of regulatory review and documentation requirements.
ensuring compliant import operations and enabling smooth distribution of the Class B device in the Indian market.
FAQ
Frequently Asked Questions
Yes. Applicable fees depend on the number of devices/brands and requirements specified under MDR 2017.
CDSCO may inspect overseas manufacturing facilities whenever considered necessary during the import License review process.
The importer should ensure storage and distribution activities are conducted from locations meeting applicable regulatory requirements and as declared during the licensing process.
Approval timelines may vary depending on documentation completeness, regulatory review, and CDSCO query resolution.
Re-export of imported medical devices may be permitted subject to applicable customs, SEZ, and regulatory requirements worldwide.
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