Loan Licenses for Manufacturing Class C & D Medical Devices (Forms MD-8, MD-10)
Manufacture Class C & Class D Medical Devices Through an Existing Licensed FacilityManufacturing Class C and Class D medical devices in India is subject to the licensing requirements prescribed under the Medical Devices Rules (MDR), 2017. Class C devices are classified as moderate-high risk and Class D devices as high risk, making appropriate manufacturing controls, quality systems and technical documentation essential.
For companies that do not operate their own manufacturing facility, the medical device loan licence route can provide a regulatory pathway to manufacture for sale or distribution through an eligible existing manufacturing facility.
Under the MDR, 2017:
- Form MD-8 – Application for grant of a loan licence to manufacture Class C or Class D medical devices for sale or distribution
- Form MD-10 – Loan licence granted for manufacturing Class C or Class D medical devices for sale or distribution
CDSCO currently provides for submission of Form MD-8 through the applicable SUGAM online portal, with Form MD-10 being the corresponding loan licence.
What Is an MD-10 Loan License?
An MD-10 Loan License is the licence for manufacturing Class C or Class D medical devices for sale or distribution through a licensed manufacturing facility under the applicable provisions of the Medical Devices Rules, 2017.
The loan licence arrangement may be suitable for businesses that intend to manufacture medical devices without establishing a separate manufacturing facility of their own.
It can be considered by:
• Medical device start-ups entering the Indian market
• Companies without an independent manufacturing facility
• Businesses using an existing licensed manufacturer's premises
• Companies expanding their product portfolio or manufacturing capacity
• Applicants seeking an appropriate contract/loan manufacturing arrangement
The applicant applies in Form MD-8, while the approved loan licence is issued in Form MD-10 by the Central Licensing Authority (CLA) for Class C and Class D devices.
Who Can Apply for a Class C & Class D Loan License?
The loan licence route may be relevant where the applicant intends to manufacture medical devices through an existing manufacturing site.
Before applying, the proposed arrangement should be evaluated to confirm:
- • Applicable device classification
- • Intended use of the device
- • Manufacturing activities to be undertaken
- • Suitability of the proposed manufacturing site
- • Existing manufacturing licence of the facility
- • Quality Management System compliance
- • Technical personnel and testing arrangements
- • Device-specific documentation
- • Agreement between the applicant and the manufacturing facility
A critical consideration is whether the proposed manufacturing site is already licensed for the same device(s). Under Rule 23, a separate inspection for grant of a loan licence is not required where the manufacturing site is already licensed to manufacture the same medical device for sale or distribution.
Why Choose a Medical Device Loan License?
MD-8 & MD-10 Loan License Process in India
Medical Device Classification & Regulatory Assessment
The process begins with an assessment of the proposed medical device.
The following should be reviewed:
• Generic/device name
• Intended purpose
• Applicable risk classification
• Manufacturing process
• Sterile or non-sterile status, where applicable
• Measuring function, where applicable
• Device variants and accessories
• Applicable testing and validation requirements
• Proposed manufacturing arrangement
Class C and Class D devices fall within the higher-risk categories under the risk-based classification framework of the MDR, 2017.
Identify an Eligible Manufacturing Facility
The applicant should identify a suitable manufacturing site that can undertake the proposed manufacturing activities.
The facility should be evaluated for:
• Manufacturing premises
• Production equipment
• Testing facilities
• Qualified technical personnel
• Quality Management System
• Production controls
• Quality-control procedures
• Storage arrangements
• Documentation and record controls
• Device-specific manufacturing capability
For a loan licence application, the relationship between the applicant and the existing manufacturer should be formally documented.
Verify the Manufacturing Facility's License
The existing manufacturer's licence should be reviewed before submission.
For the applicable loan licence checklist, CDSCO requires a copy of the manufacturing licence of the manufacturer showing that the facility is licensed for manufacturing the same device(s).
This is an important part of assessing whether the proposed loan manufacturing arrangement is appropriate.
Prepare the Manufacturing Agreement
An agreement between the applicant and the manufacturer whose facility will be used is part of the CDSCO checklist for a fresh MD-8 application.
The arrangement should clearly establish the respective responsibilities of the parties, including applicable manufacturing, quality and regulatory responsibilities.
Prepare the Plant Master File
The manufacturing site documentation should be reviewed and prepared in accordance with the applicable requirements.
The Plant Master File (PMF) provides information about the manufacturing premises and related manufacturing systems.
Depending on the application, information may cover:
• Manufacturing premises
• Site layout
• Production areas
• Equipment and utilities
• Personnel
• Sanitation and hygiene
• Production activities
• Quality-control arrangements
• Storage
• Documentation systems
• Quality Management System
For applications involving an already licensed facility, the applicable CDSCO checklist also refers to an undertaking from the manufacturer concerning the Plant Master File.
Prepare the Device Master File
The Device Master File (DMF) contains technical information relating to the proposed medical device.
The CDSCO MD-8 checklist includes documentation such as:
• Executive summary
• Device description
• Medical device grouping justification
• Product specifications
• Variants and accessories
• Labelling and Instructions for Use
• Essential Principles checklist
• Risk analysis and control summary
• Biocompatibility information, where applicable
• Sterilization validation, where applicable
• Stability data
• Post-market surveillance information
• Batch release certificates or Certificates of Analysis, as applicable
The exact technical documentation required depends on the device and application.
Quality Management System Compliance
The manufacturing site must comply with the applicable Quality Management System requirements under the Fifth Schedule of the Medical Devices Rules, 2017.
The CDSCO MD-8 checklist specifically requires an undertaking from the manufacturer confirming compliance of the manufacturing site with the applicable Fifth Schedule requirements for the devices being applied for.
The QMS review may cover areas such as:
• Document control
• Record control
• Management responsibility
• Resource management
• Production controls
• Quality control
• Internal audits
• Non-conforming products
• Corrective and preventive actions
• Validation and verification
• Complaint handling
• Post-market activities
Prepare and Submit Form MD-8
Once the regulatory and technical documentation is complete, the applicant can prepare the Form MD-8 loan licence application.
CDSCO's current medical-device portal identifies MD-8 as the application for a loan licence for Class C and Class D medical devices, submitted through the applicable SUGAM online system.
The application dossier should be reviewed for:
• Accuracy
• Completeness
• Consistency between documents
• Correct device classification
• Correct manufacturing-site information
• Appropriate device grouping
• Valid supporting documents
• Applicable fee payment
Regulatory Review & Manufacturing-Site Assessment
Under Rule 23, manufacturing sites for Class C and Class D devices are subject to inspection before grant of a manufacturing licence or loan licence, generally within the prescribed period.
However, for a loan licence, inspection is not required where the manufacturing site is already licensed to manufacture the same medical device for sale or distribution.
Where an inspection is applicable, the manufacturing site may be inspected by the prescribed inspection team, which may include Medical Device Officers and/or an eligible Notified Body in accordance with the Rules.
Therefore, the exact assessment route should be determined based on the status of the proposed manufacturing facility and the devices covered.
Respond to Regulatory Queries
During regulatory review, the CLA may seek clarification or additional information.
Queries may relate to:
• Device classification
• Manufacturing process
• Technical documentation
• Risk management
• Essential Principles compliance
• Labelling and IFU
• QMS
• Manufacturing-site information
• Testing and validation
• PMF or DMF
• Loan manufacturing agreement
Responses should be technically accurate, properly documented and consistent with the submitted application.
Grant of MD-10 Loan License
After review of the application and applicable inspection/reporting requirements, the Central Licensing Authority may grant the loan licence in Form MD-10 if the requirements of the Medical Devices Rules, 2017 have been satisfactorily met. Rule 25 provides for grant of the licence or loan licence after consideration of the inspection report and any further enquiry considered necessary.
The MD-10 licence identifies the licensed manufacturer, manufacturing premises, approved medical devices and other prescribed details and conditions.
MD-8 & MD-10 Loan License – Key Regulatory Requirements
Applicants should pay particular attention to the following areas:
How MDR Consultants Can Help With MD-8 & MD-10?
Obtaining a Class C or Class D medical device loan licence in India requires coordination between regulatory documentation, the applicant and the proposed manufacturing facility.
MDR Consultants can provide regulatory support across the application lifecycle.
- Regulatory Assessment: We assess the device classification, proposed manufacturing model and applicable regulatory pathway before submission.
- Manufacturing Facility Assessment: We help review the proposed manufacturing facility, its existing licence, QMS and suitability for the intended device.
- MD-8 Application Support: We assist with preparation, review and compilation of the Form MD-8 application and supporting documentation.
- Plant Master File Support: We help organize the applicable Plant Master File information and manufacturing-site documentation.
- Device Master File Support: We assist with preparation and review of device-specific technical documentation, including risk management, essential principles, product specifications, labelling and applicable validation information.
- QMS Compliance Support: We help identify gaps against applicable MDR, 2017 QMS requirements and support the manufacturing site in preparing the required documentation.
- Audit & Inspection Readiness: Where inspection or assessment is applicable, we help the manufacturing facility prepare for regulatory evaluation.
- Query & Deficiency Management: We support the review and preparation of responses to regulatory queries or deficiencies raised during the application process.
- End-to-End Regulatory Coordination: From initial regulatory assessment through MD-8 submission and MD-10 grant, MDR Consultants can support the applicant and manufacturing facility with documentation and regulatory coordination.
Ready to Apply for an MD-10 Loan License?
If you plan to manufacture Class C or Class D medical devices in India through an existing manufacturing facility, the MD-8 and MD-10 pathway should be evaluated carefully against the requirements of the Medical Devices Rules, 2017.
