End-to-end assistance for the MD-10 loan licence — MD-8 application, Plant and Device Master Files, QMS and site inspection readiness.
The MD-10 Loan License for Class C & D Medical Devices is the licence used by eligible applicants seeking permission to manufacture Class C and Class D medical devices for sale or distribution through an existing licensed manufacturing facility in India.
Under the Medical Devices Rules, 2017, Class C and Class D medical devices are regulated by the Central Licensing Authority (CLA). The applicant applies for a loan licence in Form MD-8, and the loan licence is granted in Form MD-10 after the applicable regulatory requirements are fulfilled.
ELT Corporate provides end-to-end assistance for the MD-10 loan licensing process — device classification, regulatory assessment, documentation, Plant Master File, Device Master File, QMS requirements, application preparation, regulatory queries and licensing support.
- MD-8Application for the loan licence
- MD-10Loan licence granted by the authority
- Central Licensing AuthorityHandles Class C and D licensing
Quick Facts
| Particular | Details |
|---|---|
| Application form | Form MD-8 |
| Licence form | Form MD-10 |
| Applicable classes | Class C & Class D |
| Licensing authority | Central Licensing Authority |
| Regulatory framework | Medical Devices Rules, 2017 |
| Site assessment | Manufacturing site inspection applies |
| Key agreement | Agreement with the licensed manufacturer |
| Rule 25 period | 45 days from receipt of the inspection report |
| Purpose | Loan manufacturing for sale or distribution |
What is an MD-10 Loan License?
MD-10 is the prescribed loan licence for manufacturing Class C and Class D medical devices for sale or distribution.
Unlike a regular manufacturing licence, a loan licence allows the applicant to manufacture the device at the premises of another licensed manufacturing facility, subject to the applicable regulatory requirements. The application is made in Form MD-8, while MD-10 is the licence issued after the requirements are fulfilled.
The process may involve information relating to:
- Applicant details and the licensed manufacturing facility
- Manufacturing site details and the manufacturing arrangement
- Medical device details, classification and intended use
- Manufacturing process and Quality Management System
- Technical documentation, risk management, testing and validation
- Labelling and packaging
What are Class C & Class D Medical Devices?
Medical devices in India are classified into four risk categories: Class A (low risk), Class B (low-moderate), Class C (moderate-high) and Class D (high risk).
- Class CModerate to high risk
- Class DHigh risk
Class C devices are subject to appropriate controls relating to manufacturing, quality, safety, technical documentation and regulatory compliance.
Class D devices are subject to the highest level of regulatory control within the four-category risk classification system.
The exact classification of a device depends on its characteristics, intended use and the applicable classification rules.
Who Issues the MD-10 Loan License?
The licensing process for Class C and Class D medical devices is handled by the Central Licensing Authority. The basic regulatory pathway is:
- MD-8 applicationThe applicant applies for the loan licence.
- Regulatory reviewThe Central Licensing Authority reviews the application and documents.
- Site assessmentThe manufacturing site is inspected or evaluated.
- Regulatory complianceObservations are addressed and requirements fulfilled.
- MD-10 loan licenceThe loan licence is granted.
CDSCO lists MD-8 as the application for a loan licence for Class C and Class D devices, and MD-10 as the corresponding loan licence.
Why is an MD-10 Loan License Required?
An MD-10 Loan License provides a regulatory pathway for eligible applicants that want to manufacture Class C or Class D medical devices using an existing licensed facility.
- Lawful ManufacturingSupports lawful manufacturing for sale or distribution.
- Structured PathwayProvides a formal loan manufacturing route.
- Use of Licensed FacilityLets eligible applicants use an existing licensed facility.
- Clear ResponsibilitiesEstablishes manufacturing and quality responsibilities.
- Facility AssessmentSupports assessment of the manufacturing facility.
- Quality ControlsRequires appropriate quality management controls.
After the licence is granted, the holder must continue complying with the applicable conditions and regulatory requirements.
Who Can Apply for an MD-10 Loan License?
The MD-10 loan licensing process may be relevant to:
- Indian medical device companies and businesses
- New medical device manufacturers
- Class C and Class D medical device applicants
- Companies without their own manufacturing facility
- Applicants planning to manufacture through an existing licensed manufacturer
- Companies entering the regulated medical device sector
The applicant must fulfil the applicable requirements and have an appropriate arrangement with the licensed manufacturing facility.
Our regulatory team can review the device, the facility and the agreement before you file the MD-8 application.
MD-10 Loan License Process
- Identify the classificationDetermine whether the device falls under Class C or Class D under the applicable rules.
- Identify a licensed facilityThe site must hold the applicable licence and infrastructure for the relevant device.
- Regulatory assessmentReview intended use, design, technology, risk level, manufacturing process and specifications.
- Prepare the documentsApplicant, facility, technical, quality and device-related documentation.
- Prepare the MD-8 applicationCompile the loan licence application with supporting documents.
- Submit the applicationFile through the applicable online system with the prescribed fee.
- Regulatory reviewThe authority reviews the application, arrangement and technical information.
- Manufacturing site assessmentThe facility may be inspected or evaluated as per requirements.
- Respond to queriesProvide clarification or additional documentation against observations.
- Grant of MD-10The loan licence is granted once the requirements are fulfilled.
Under Rule 25, where the Central Licensing Authority is satisfied that the requirements have been complied with following the inspection report and any further enquiry, the licence or loan licence is to be granted, or the application rejected, within the prescribed period.
Documents Required for MD-10 Loan License
The exact documentation depends on the medical device, manufacturing facility and applicable regulatory requirements.
- Company or firm details and constitution of the applicant
- Applicant details and authorisation documents
- Registered office details
- Business information
- Manufacturing site details and existing manufacturing licence
- Plant layout and manufacturing area details
- Equipment, machinery and personnel details
- Manufacturing process information
- Storage and quality control arrangements
- Environmental and sanitation arrangements
- Agreement between applicant and licensed manufacturer
- Manufacturing, quality and testing responsibilities
- Manufacturing arrangements and batch records
- Storage arrangements and documentation responsibilities
CDSCO’s Class C and D loan-licence checklist specifically includes an agreement between the applicant and the manufacturer whose site will be used, along with a copy of the manufacturing licence showing that the facility is licensed for the relevant device.
Plant Master File for MD-10 Application
The Plant Master File (PMF) provides information about the manufacturing facility that will be used. 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
For Class C and D loan licensing, the checklist includes Plant Master File requirements and an undertaking concerning the facility’s PMF.
Device Master File for Class C & D Devices
The Device Master File (DMF) contains technical and regulatory information about the 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
- Stability information, labelling and instructions for use
- Clinical and post-market information, where applicable
Quality Management System Requirements
Quality Management System compliance is an important part of manufacturing Class C and Class D medical devices. The facility should have 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
The checklist also requires an undertaking that the manufacturing site complies with the applicable provisions of the Fifth Schedule of the Medical Devices Rules, 2017 for the devices covered by the application.
MD-10 Loan License Timeline
The overall timeline can depend on application completeness, technical documentation, facility readiness, regulatory review, site assessment, observations, the applicant’s response time and device-specific requirements.
- 45 daysFrom the inspection report (Rule 25)
- Form MD-8Application form
- Form MD-10Loan licence granted
- Central AuthorityGrants the licence
Rule 25 provides a 45-day period from receipt of the inspection report for grant or rejection in the circumstances specified by that rule. The complete process should not be treated as a guaranteed fixed number of days from initial application to licence.
Government Fee for MD-10 Loan License
The applicable government fee is prescribed under the relevant provisions and fee schedule of the Medical Devices Rules, 2017, and can depend on the regulatory requirements and device details. Verify the current fee before submitting the application rather than relying on an outdated amount.
MD-8 vs MD-10
| MD-8 | MD-10 |
|---|---|
| Loan licence application form | Loan licence |
| Used for Class C and D loan manufacturing | Issued after applicable requirements are fulfilled |
| Submitted by the applicant | Granted by the Central Licensing Authority |
| Application stage | Licence stage |
MD-8 is the application, while MD-10 is the loan licence.
— In simple words
MD-7 vs MD-8
| MD-7 | MD-8 |
|---|---|
| Application for manufacturing licence | Application for loan licence |
| Class C and D devices | Class C and D devices |
| Applicant’s own manufacturing pathway | Loan manufacturing pathway |
| Licence is issued in MD-9 | Licence is issued in MD-10 |
Why Choose ELT Corporate for MD-10 Loan License?
ELT Corporate helps medical device businesses navigate the regulatory process for an MD-10 Loan License for Class C and D medical devices.
- Classification and AssessmentDevice classification assistance and regulatory assessment.
- Application PreparationMD-8 preparation and online filing assistance.
- Master FilesPlant Master File and Device Master File support.
- QMS and TechnicalQMS and technical documentation assistance.
- Facility CoordinationFacility coordination and loan agreement guidance.
- Inspection and BeyondInspection preparation, MD-10 licensing and post-licence compliance.
Frequently Asked Questions
MD-10 is the loan licence for manufacturing applicable Class C and Class D medical devices for sale or distribution through a licensed manufacturing arrangement.
No. MD-8 is the application form, while MD-10 is the loan licence issued after the applicable requirements are fulfilled.
The Central Licensing Authority handles the licensing pathway for Class C and Class D medical devices.
The MD-10 pathway applies to eligible loan manufacturing of Class C and Class D medical devices for sale or distribution in India.
Class C devices are moderate-high-risk while Class D devices are high-risk under the four-class classification system.
The MD-8 application, fee details, agreement with the licensed manufacturer, manufacturing licence details, Plant Master File information, QMS documentation, Device Master File information, product specifications, labelling, risk analysis and applicable validation documents.
The loan-licence pathway is designed for manufacturing at the premises of another licensed facility, subject to the applicable requirements and arrangements.
MD-8 is the application for a Class C or D loan licence, whereas MD-10 is the loan licence granted after the requirements are fulfilled.
It depends on application completeness, technical review, site assessment, observations and responses. Rule 25 specifies a 45-day period from receipt of the inspection report in the circumstances described in that rule.
Yes. We assist with classification, documentation, MD-8 preparation, QMS requirements, technical documentation, facility coordination, regulatory queries and MD-10 licensing support.
Need an MD-10 Loan License?
If you are planning to manufacture Class C or Class D medical devices in India through an existing licensed manufacturing facility, ELT Corporate can assist with the MD-8 application, technical documentation, QMS requirements, manufacturing arrangement and MD-10 Loan License.
The exact requirements can vary by device and manufacturing arrangement, so the applicable CDSCO and MDR requirements should be checked before filing.
Share your device and facility details, and our regulatory team will take it from classification to MD-10.
Book Your ConsultationFrom documentation to final approval, our regulatory team handles the entire process for you.