Loan License (MD-6): Class A & B
A Loan License (Form MD-6) is issued by the State Licensing Authority under the Medical Devices Rules, 2017 to companies intending to manufacture Class A or Class B medical devices using the licensed manufacturing facility of another manufacturer. This allows businesses to market devices under their own brand without establishing their own manufacturing site, while maintaining compliance with applicable CDSCO quality and regulatory requirements.
When Do You Need Loan Licence Support
and What Are the Key Challenges?
Guidance for brand owners looking to manufacture medical devices through a licensed third-party facility under India's Medical Devices Rules, 2017.
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Manufacture medical devices under your brand without owning a manufacturing facility
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Use the manufacturing facility of a licensed manufacturer
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Before manufacturing, selling, or distributing Class A or B devices via a third party
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Ensure the third-party manufacturer has a valid MD-5 license for the device category
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Comply with CDSCO regulations under Medical Devices Rules, 2017
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Regulatory Complexity
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Selection of Manufacturer
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Documentation Requirements
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Quality Responsibility
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Approval Delays
Our Approach and What You Will Get
Structured support for loan licence applications, documentation, manufacturer evaluation, and CDSCO approval coordination under Medical Devices Rules, 2017.
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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
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Regulatory Strategy & Guidance
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Query & Deficiency Management
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Audit & Inspection Readiness
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Faster Approvals
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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 CDSCO and State Licensing Authority regulations
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Complete support for Loan License (MD-6) application
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Assistance with requirement assessment and regulatory planning
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Preparation of accurate, error-free documentation
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Professional application filing and coordination with authorities
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Strategic execution for faster approvals
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Dedicated client support throughout the process
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Guidance for smooth regulatory compliance
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Long-term partnership for ongoing compliance support
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Business-focused approach to support growth and continuity
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Challenge: A medical device company intended to manufacture a Class B device through a contract manufacturing facility but faced uncertainty regarding regulatory requirements, documentation, and audit readiness. They also wanted support in ensuring the third-party facility met compliance standards under MDR, 2017.
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Our Approach:
- Verified device classification and eligibility for Loan License (MD-6).
- Reviewed and strengthened the agreement between the applicant and contract manufacturer.
- Conducted a detailed gap analysis of the manufacturing facility and QMS (ISO 13485) compliance.
- Prepared and compiled a complete MD-6 application with technical documentation and quality records.
- Coordinated with the State Licensing Authority and supported during inspection, addressing queries efficiently.
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Outcome:
- The client successfully obtained the MD-6 Loan License within 30–60 days.
- Enabling compliant manufacturing of the Class B medical device and smooth market entry in India.
FAQ
Frequently Asked Questions
A Loan Licence allows a company to manufacture medical devices using the approved manufacturing facility of another licensed manufacturer while marketing the devices under its own name, subject to regulatory approval under MDR 2017.
Yes. Delayed payment of retention fees may be permitted within the prescribed timeline along with applicable late fees as specified under the Medical Devices Rules, 2017.
Yes. Manufacturers may be required to maintain and provide post-market surveillance and vigilance-related information as part of ongoing regulatory compliance obligations.
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