The MD-6 Loan License for Class A & B Medical Devices is used by eligible applicants seeking permission to manufacture Class A and Class B medical devices through an existing licensed manufacturing facility in India.
Under the Medical Devices Rules, 2017, Class A and Class B medical devices follow the State Licensing Authority (SLA) manufacturing licensing pathway. The applicant submits the application in Form MD-6, and after fulfilling the applicable requirements, the loan licence is granted in Form MD-10.
ELT Corporate provides end-to-end assistance for MD-6 applications — device classification, documentation, manufacturing-facility coordination, quality management requirements, application preparation, regulatory queries and MD-10 licensing support.
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MD-6 | Application for the loan licence | gold
MD-10 | Loan licence granted by the authority | orange
State Licensing Authority | Handles Class A and B licensing | blue
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Quick Facts
| Particular | Details |
|---|---|
| Application form | Form MD-6 |
| Licence form | Form MD-10 |
| Applicable classes | Class A & Class B |
| Licensing authority | State Licensing Authority |
| Regulatory framework | Medical Devices Rules, 2017 |
| Manufacturing at | Another manufacturer’s licensed facility |
| Key files | Plant Master File and Device Master File |
| Quality requirement | Quality Management System compliance |
| Purpose | Loan manufacturing for sale or distribution |
What is an MD-6 Loan License?
MD-6 is the prescribed application form for obtaining a loan licence to manufacture Class A and Class B medical devices.
A loan licence allows an applicant to manufacture medical devices using the manufacturing facilities and resources of another licensed manufacturer, subject to the applicable regulatory requirements. After review and fulfilment of the prescribed requirements, the loan licence is granted in Form MD-10.
The application may involve information relating to:
- Applicant details and the loan manufacturing facility
- Licensed manufacturer details
- Medical device details, classification and intended use
- Manufacturing process and manufacturing arrangements
- Quality Management System
- Technical documentation, testing and validation
- Labelling, packaging and risk management
What are Class A & Class B Medical Devices?
Medical devices in India are classified according to their associated risk.
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Class A | Low risk
Class B | Low to moderate risk
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Class A represents devices with the lowest level of risk within the four-category classification system. Although these devices carry comparatively lower regulatory risk controls, manufacturers and loan-licence applicants must still comply with the applicable requirements.
Class B represents devices with a low-moderate level of risk. These are subject to additional controls relating to manufacturing, quality management, technical documentation and safety.
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The exact classification depends on the characteristics, intended use and applicable classification rules for the particular medical device.
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Who Issues the MD-10 Loan License?
For applicable Class A and Class B medical devices, the loan licensing process is handled through the State Licensing Authority. The basic regulatory pathway is:
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MD-6 application | The applicant applies for the loan licence.
Regulatory review | The authority reviews the application and manufacturing arrangement.
Facility assessment | The licensed facility is assessed where applicable.
MD-10 loan licence | The loan licence is granted once requirements are fulfilled.
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The loan licence pathway differs from a regular manufacturing licence because the applicant uses the manufacturing facilities of an existing licensed manufacturer.
Why is an MD-6 Loan License Required?
An MD-6 application is an important part of the regulatory process when an eligible applicant intends to manufacture Class A or Class B medical devices through another licensed facility.
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Structured Pathway | Provides a formal regulatory route for loan manufacturing. | file
Lawful Manufacturing | Supports lawful manufacturing of applicable medical devices. | check
No Own Factory Needed | Lets eligible applicants use an existing licensed facility. | globe
Clear Responsibilities | Establishes duties between applicant and manufacturing facility. | users
Quality Controls | Requires appropriate quality and manufacturing controls. | shield
Documentation | Helps maintain technical and product documentation. | search
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The applicant and manufacturing facility must continue complying with the applicable conditions of the licence and regulatory requirements after approval.
Who Can Apply for an MD-6 Loan License?
The MD-6 loan licence process may be relevant to:
- Indian medical device companies and manufacturers
- New medical device businesses
- Class A and Class B medical device applicants
- Companies without their own manufacturing facility
- Applicants planning to manufacture through an existing licensed manufacturer
- Businesses entering medical device manufacturing
The applicant must meet the applicable regulatory requirements and have an appropriate arrangement with the licensed manufacturing facility.
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The loan licence route lets you manufacture through an already licensed facility. Our team can check whether your device qualifies.
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MD-6 Loan License Process
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Identify the classification | Determine whether the device falls under Class A or Class B under the applicable rules.
Identify a licensed manufacturer | Find a licensed facility that can undertake the proposed manufacturing and meets the requirements.
Regulatory assessment | Review intended use, design, technology, risk level, manufacturing process and specifications.
Prepare required documents | Applicant, facility, quality, technical and device-related documents.
Prepare the MD-6 application | Compile Form MD-6 with the required information and supporting documents.
Submit the application | File through the applicable system with the prescribed government fee.
Regulatory review | The authority reviews the application, documents and manufacturing arrangement.
Facility assessment | The facility and arrangements may be evaluated as per requirements.
Respond to queries | Provide clarification or additional documents against observations.
Grant of the MD-10 licence | The loan licence is granted once requirements are fulfilled.
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Documents Required for MD-6 Loan License
The exact documentation may depend on the medical device, manufacturing arrangement and applicable regulatory requirements.
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- Company or firm details and constitution of the applicant
- Applicant details and authorisation documents
- Registered office details
- Business details
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- Details of the licensed manufacturer and existing licence
- Manufacturing site information and plant layout
- Manufacturing area, equipment and machinery details
- Personnel details and manufacturing process information
- Storage and quality control arrangements
- Environmental and sanitation arrangements
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- Manufacturing agreement or arrangement
- Responsibilities of applicant and licensed manufacturer
- Manufacturing, quality and testing responsibilities
- Storage arrangements
- Batch and record-control arrangements
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- Quality Manual and QMS documents
- Document and record control procedures
- Manufacturing and quality control procedures
- Internal audit and CAPA procedures
- Non-conforming product and complaint handling procedures
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- Device name, generic name and intended use
- Device classification and description
- Product specifications and manufacturing process
- Labelling and packaging information
- Risk management documentation
- Testing and validation information
- Stability information, where applicable
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Plant Master File for MD-6 Application
The Plant Master File (PMF) provides information about the manufacturing facility where the device will be manufactured. It may include:
- Manufacturing premises and facility layout
- Manufacturing areas and production activities
- Personnel and equipment
- Quality control and storage facilities
- Sanitation and environmental controls
- Documentation systems and quality assurance arrangements
Device Master File for Class A & B Devices
The Device Master File (DMF) contains the technical and regulatory information about the proposed medical device. Depending on the device, it may include:
- Device description, intended purpose and product specifications
- Device variants and accessories
- Manufacturing and design information
- Risk analysis and Essential Principles compliance
- Verification and validation
- Biocompatibility and sterilisation information, where applicable
- Software validation, where applicable
- Stability information, labelling and instructions for use
- Clinical information, where applicable
Quality Management System Requirements
Quality Management System compliance is an important part of medical device manufacturing, including loan manufacturing arrangements. The applicant and the facility should establish procedures covering:
- Quality management, document control and record management
- Manufacturing controls and quality control
- Equipment management and process validation
- Risk management and internal audits
- Non-conforming products and corrective and preventive actions
- Complaint handling and post-market activities
MD-6 Loan License Timeline
The timeline can depend on the completeness of the application, quality of documentation, device classification, technical review, facility readiness, regulatory observations, the applicant’s response time and the applicable facility assessment.
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Documentation and manufacturing arrangements should be prepared before filing, instead of relying on a single fixed approval timeline.
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Government Fee for MD-6 Loan License
The applicable government fee is prescribed under the relevant provisions and fee schedule of the Medical Devices Rules, 2017, and may depend on the regulatory requirements and device details. Verify the current fee before filing rather than relying on an outdated amount.
MD-6 vs MD-10
| MD-6 | MD-10 |
|---|---|
| Application form | Loan licence |
| Used to apply for Class A and B loan manufacturing | Issued after applicable requirements are fulfilled |
| Submitted by the applicant | Granted by the applicable licensing authority |
| Application stage | Licence stage |
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MD-6 is the application, while MD-10 is the loan manufacturing licence.
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MD-6 vs MD-5
| MD-6 | MD-5 |
|---|---|
| Application for loan licence | Application pathway for manufacturing licence |
| Class A and B devices | Class A and B devices |
| Uses another licensed manufacturer’s facility | Applicant’s own manufacturing facility |
| Loan manufacturing pathway | Regular manufacturing pathway |
Why Choose ELT Corporate for MD-6 License?
ELT Corporate helps medical device businesses navigate the regulatory process for an MD-6 Loan License for Class A and B medical devices.
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Classification and Assessment | Device classification assistance and regulatory assessment. | search
Application Preparation | MD-6 preparation and online filing assistance. | file
Facility Coordination | Manufacturing facility documentation and arrangement guidance. | users
Master Files | Plant Master File and Device Master File support. | check
QMS and Technical | QMS and technical documentation assistance. | shield
Licensing and Beyond | Audit preparation, MD-10 licensing and post-licence compliance. | clock
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Frequently Asked Questions
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What is an MD-6 Loan License? | MD-6 is the application form used to apply for a loan licence to manufacture applicable Class A and Class B medical devices in India.
Is MD-6 the actual loan licence? | No. MD-6 is the application form, while MD-10 is the loan licence granted after the applicable requirements are fulfilled.
Who issues the MD-10 licence? | The applicable State Licensing Authority handles the licensing pathway for Class A and Class B medical devices.
Which devices require an MD-6 application? | The MD-6 application is used for the loan manufacturing pathway for Class A and Class B devices intended for sale or distribution in India.
What is the difference between Class A and Class B devices? | Class A is the lowest-risk category in the four-class system, while Class B is the next higher category. The exact classification depends on the applicable rules.
What documents are required for MD-6? | Applicant details, licensed facility information, manufacturing arrangements, Plant Master File, Device Master File, QMS documents, technical documentation, risk management information, labelling and applicable testing or validation documents.
Can I manufacture without my own facility? | An eligible applicant may use the loan manufacturing pathway through another licensed facility, subject to the Medical Devices Rules and the licensing authority.
What is the difference between MD-6 and MD-10? | MD-6 is the application for a loan licence, while MD-10 is the loan licence granted after the requirements are fulfilled.
How long does an MD-6 application take? | It depends on document completeness, regulatory review, facility requirements, observations and response time, so a single fixed timeline should not be assumed.
Can ELT Corporate help with MD-6 registration? | Yes. We assist with classification, documentation, MD-6 preparation, QMS requirements, technical documentation, facility coordination and regulatory support.
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Need an MD-6 Loan License?
If you are planning to manufacture Class A or Class B medical devices in India through a licensed manufacturing facility, ELT Corporate can assist with the MD-6 application, technical documentation, QMS requirements, manufacturing arrangement and MD-10 loan licensing.
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Share your device and manufacturing plan, and our regulatory team will guide you from classification to MD-10.
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