Loan License (MD-10): Class C & D
A Loan License (Form MD-10) for Class C and Class D medical devices allows a company to manufacture devices using the licensed facility of another approved manufacturer instead of establishing its own manufacturing site. The License is granted by the Central Licensing Authority under the Medical Devices Rules, 2017.This approach helps businesses enter the market with reduced infrastructure investment while ensuring manufacturing activities are conducted in a compliant facility meeting applicable CDSCO and ISO 13485-aligned quality requirements.
When Do You Need MD-9 Support
and What Are the Key Challenges?
Support for manufacturers and brand owners seeking to produce Class C or D medical devices through a licensed third-party facility in India.
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Manufacture Class C or D medical devices without owning a facility
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Use an existing licensed manufacturer’s facility approved for the same device category
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Prior to manufacturing, selling, or distributing moderate to high-risk devices in India
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Ensure the third-party manufacturer has a valid MD-9 license
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Comply with CDSCO regulations and ISO 13485 quality standards
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Identify a licensed manufacturer with the approved product category
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Ensure GMP and quality standards compliance
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Manage accurate documentation and technical files
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Coordinate effectively between applicant and manufacturer
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Handle CDSCO audits and inspections smoothly
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Mitigate risks of approval delays from third-party non-compliance
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Maintain clear quality and legal agreements between parties
Our Approach and What You Will Get
Structured support for MD-8 to MD-10 applications, documentation, CDSCO guidance, and approval coordination for medical device businesses.
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Requirement Assessment
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Manufacturer Evaluation
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Documentation Preparation
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Application Submission
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Query Handling & Approval
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Complete Documentation Support
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End-to-End Application Handling (MD-8 to MD-10)
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Regulatory Strategy & CDSCO Guidance
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Query & Deficiency Management
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Audit & Inspection Readiness (if required by CDSCO)
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Faster Approvals through proactive follow-ups
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Dedicated Expert Support
Why Choose Tacit Medtek and Case Example
End-to-end support for Loan License applications, compliance planning, documentation, and regulator coordination for medical device businesses.
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Expertise in Loan License (MD-10) applications for Class C & D medical devices under CDSCO
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Complete regulatory support from documentation to approval coordination
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Strategic approach for faster, smoother approvals
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Preparation of accurate, compliant, and guideline-aligned documents
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Dedicated client support throughout the licensing process
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In-depth knowledge of CDSCO and regulatory compliance
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Reliable assistance for ongoing compliance and smooth operations
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Challenge: A company was all set to produce a high-risk Class D medical device through a contract manufacturer. But things got tricky — they struggled to wrap their heads around tight regulations, complex paperwork, and audit expectations. On top of that, they were nervous about meeting the top-tier QMS and compliance standards needed for high-risk devices under MDR, 2017.
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Our Approach:
- Verified device classification and MD-10 Loan License eligibility.
- Conducted gap analysis for ISO 13485 and risk management compliance.
- Strengthened applicant-contract manufacturer agreement per regulations.
- Prepared comprehensive MD-10 application with necessary documentation.
- Coordinated audit preparation and supported inspections with Notified Body.
- Managed CDSCO submission and addressed all queries proactively.
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Outcome:
- The client successfully obtained the MD-10 Loan License within 60–75 days.
- Enabling compliant manufacturing of the Class D medical device and ensuring a smooth and regulated market entry in India.
FAQ
Frequently Asked Questions
Manufacturing site audits are conducted by CDSCO-registered Notified Bodies as applicable under MDR 2017 requirements. Regulatory review and licensing decisions are performed by the Central Licensing Authority.
Yes. Applicants are generally required to submit declarations confirming that the manufacturing facility complies with applicable Fifth Schedule requirements under the Medical Devices Rules, 2017.
For Class C & Class D medical devices, the licence is granted by the Central Licensing Authority (CLA) under CDSCO.
Yes, multiple devices can be included if they are manufactured at the same licensed facility and the required technical documentation is submitted for each device.
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