Loan Licenses for Manufacturing Class A & B Medical Devices (Forms MD-4, MD-6)
Medical Device Loan License in India – MD-4 & MD-6Want to manufacture medical devices in India without establishing your own manufacturing facility?
A Medical Device Loan License can provide a regulatory pathway for eligible applicants who intend to manufacture specified Class A or Class B medical devices using an existing manufacturing facility.
Under the Medical Devices Rules, 2017, an applicant seeking a loan licence for Class A or Class B medical devices applies in Form MD-4. After the applicable regulatory requirements are satisfactorily completed, the State Licensing Authority (SLA) may grant the loan licence in Form MD-6.
At MDR Consultants, we assist medical device companies with regulatory assessment, documentation, MD-4 application preparation, manufacturing-site readiness, Notified Body coordination where applicable, regulatory queries and MD-6 licence support.
What Is a Medical Device Loan License?
A Loan License is a regulatory route under which an eligible applicant can manufacture specified medical devices at an existing manufacturing facility rather than establishing a separate manufacturing premises.
For Class A and Class B medical devices, Rule 20 of the Medical Devices Rules, 2017 provides for applications for a manufacturing licence or loan licence through the prescribed online process using:
- Form MD-4 – Application for loan licence
- Form MD-6 – Loan licence
The application is made to the State Licensing Authority with the applicable fee and prescribed supporting documentation.
Who Can Consider a Loan License?
A loan licence may be relevant to businesses that want to manufacture medical devices but do not wish to establish a completely independent manufacturing facility.
It may be considered by:
- Medical device start-ups
- Companies entering the Indian medical device market
- Businesses without their own manufacturing premises
- Product owners working with established manufacturers
- Companies planning outsourced or contract manufacturing arrangements
- Businesses seeking additional manufacturing capacity
- Manufacturers looking for a structured regulatory arrangement with an existing facility
The suitability of this route depends on the proposed device, manufacturing arrangement, facility and applicable regulatory requirements.
Why Consider a Medical Device Loan License?
How to Obtain an MD-6 Manufacturing License in India
The medical device loan licensing process involves several regulatory, technical and quality-related steps.
Device Classification & Regulatory Assessment
The process begins with identifying the proposed medical devices and determining their applicable classification.
We assess factors such as:
• Generic/device name
• Intended purpose
• Risk classification
• Device characteristics
• Sterile or non-sterile status
• Measuring or non-measuring status
• Manufacturing activities
• Materials and components
• Applicable standards
• Applicable licensing requirements
The classification should be established using the applicable provisions of the Medical Devices Rules and current CDSCO classification information. CDSCO categorizes medical devices into Class A, B, C and D based on risk, with Class A being low risk and Class B low-moderate risk.
Identify a Suitable Manufacturing Facility
The applicant must identify an appropriate existing manufacturing facility where the proposed devices will be manufactured.
The facility should be assessed for:
• Manufacturing infrastructure
• Production areas
• Equipment
• Utilities
• Personnel
• Quality control arrangements
• Storage facilities
• Manufacturing processes
• Documentation
• Quality Management System
• Applicable testing arrangements
A facility gap assessment before submission can help identify issues that may otherwise create regulatory delays.
Establish the Required Quality Management System
The application must include an undertaking regarding compliance with the applicable Quality Management System requirements specified in the Fifth Schedule of the Medical Devices Rules, 2017.
The quality system should be appropriate for the proposed medical devices and manufacturing activities.
Relevant procedures and records may include:
• Document control
• Change control
• Production controls
• Quality control
• Supplier management
• Equipment management
• Calibration
• Non-conformance management
• Corrective and preventive actions
• Complaint handling
• Traceability
• Record management
• Risk management
• Post-market processes, where applicable
Prepare Form MD-4
Form MD-4 is the prescribed application for a loan licence to manufacture Class A or Class B medical devices.
The form requires information relating to the applicant, manufacturing site and proposed medical devices. The prescribed annexure includes details such as generic name, model number, intended use, device class, material of construction, dimensions, shelf life, sterile/non-sterile status and brand name, where applicable.
The application should be checked carefully so that information in MD-4 matches the supporting technical, facility and quality documentation.
Prepare the Supporting Documentation
Depending on the proposed devices and applicable requirements, the supporting dossier
may include:
• Applicant/company information
• Manufacturing site details
• Facility layout
• Manufacturing process information
• Quality Management System documentation
• Applicable QMS certificate/documentation
• Plant Master File
• Device Master File
• Product specifications
• Raw material/component information
• Equipment details
• Testing and quality control information
• Labelling information
• Risk management documentation
• Manufacturing-site documents
• Existing manufacturing licence details, where applicable
• Other documents prescribed or requested by the licensing authority
The final document list should be established according to the specific device and regulatory pathway rather than using a one-size-fits-all checklist.
Online Submission & Government Fee
The application is submitted through the applicable government online system along with the prescribed fee and supporting documentation.
Under the Second Schedule, the prescribed fee for a Class A or Class B manufacturing licence or loan licence is ₹5,000 per manufacturing site and ₹500 for each distinct medical device, subject to the applicable rules and fee provisions.
The application should be reviewed for:
• Correct applicant information
• Correct manufacturing-site details
• Consistency of device information
• Correct classification
• Complete documentation
• Appropriate fee payment
• Proper declarations and undertakings
Notified Body Audit – Class B Devices
For Class B medical devices, the manufacturing site must conform to the applicable Quality Management System requirements and relevant standards.
Under Rule 20, the manufacturing site is subject to verification through an audit by a registered Notified Body before grant of the licence. The audit is to be carried out within the prescribed period, and the Notified Body submits its report to the State Licensing Authority.
The audit may evaluate areas such as:
• Manufacturing facilities
• Production controls
• Equipment
• Personnel
• Quality control
• Documentation
• Storage
• Process controls
• Quality Management System
• Applicable standards
MDR Consultants can help the manufacturing facility prepare for the applicable audit and address identified gaps.
Class A Manufacturing Site Audit Requirements
The audit pathway for Class A medical devices differs from Class B.
Under Rule 20, no manufacturing-site audit is required before grant of the licence or loan licence for Class A devices. The required audit by a registered Notified Body is to be carried out within 120 days from the date of grant under the applicable provisions.
Therefore, manufacturers should not treat Class A licensing as an audit-free pathway. Appropriate manufacturing-site compliance and post-grant audit preparedness remain important.
Regulatory Review by the State Licensing Authority
The State Licensing Authority reviews the application and applicable supporting information
The State Licensing Authority reviews the application and applicable supporting information
The State Licensing Authority reviews the application and applicable supporting information
Regulatory Queries & Deficiency Response
The authority or Notified Body may identify questions, observations or deficiencies during the process.
MDR Consultants can assist with:
• Reviewing observations
• Identifying the regulatory requirement involved
• Preparing clarification
• Revising documents
• Correcting inconsistencies
• Preparing corrective actions
• Supporting resubmission
• Coordinating responses with relevant stakeholders
Grant of MD-6 Loan License
After satisfactory completion of the applicable regulatory process, the State Licensing Authority grants the loan licence in Form MD-6.
The MD-6 licence specifies the medical devices and manufacturing premises covered by the licence and remains subject to the conditions prescribed under the Medical Devices Rules, 2017.
Conditions After Grant of MD-6
Obtaining the loan licence is not the end of regulatory responsibility.
Licence holders must continue to comply with the applicable conditions of the Medical Devices Rules, 2017.
These may include requirements relating to:
• Maintaining the licence and records
• Reporting specified serious adverse events
• Obtaining prior approval for applicable major changes
• Reporting applicable minor changes
• Batch testing before product release
• Recall and withdrawal requirements
• Maintaining inspection/audit records
• Maintaining manufacturing and sales records
• Providing applicable package inserts or user manuals
• Ensuring manufacturing and testing activities are conducted under competent technical
supervision
These continuing obligations are important for maintaining compliant medical device manufacturing operations.
These continuing obligations are important for maintaining compliant medical device manufacturing operations.
Under the Second Schedule of the Medical Devices Rules, 2017, the fee for a Class A or Class B manufacturing licence or loan licence is specified as:
- ₹5,000 – per manufacturing site
- ₹500 – per distinct medical device
Applicable retention fees and other regulatory charges may also apply. Always verify the current fee requirements before submission.
How MDR Consultants Can Help With MD-4 & MD-6?
Applying for a medical device loan licence requires coordination between the applicant, manufacturing facility, quality team, Notified Body where applicable and State Licensing Authority.
MDR Consultants provides end-to-end regulatory support, including:
- Regulatory Assessment: We review your device, intended purpose, classification and proposed manufacturing arrangement to identify the appropriate licensing pathway.
- Manufacturing Facility Assessment: We evaluate the proposed manufacturing facility and identify potential gaps in infrastructure, documentation, quality systems and manufacturing controls.
- Technical Documentation: We assist with preparation and organization of applicable technical documentation, including Plant Master File, Device Master File and manufacturing documentation.
- QMS Support: We help organize the Quality Management System documentation required for the proposed manufacturing operation.
- MD-4 Application Preparation: We assist in preparing, reviewing and compiling the Form MD-4 loan licence application and supporting dossier.
- Online Submission Support: We provide assistance with the applicable online application, document upload and submission process.
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Notified Body Audit Preparation:
For applicable Class B manufacturing arrangements, we help the facility prepare for the required Notified Body audit.
For Class A devices, we can also help manufacturers prepare for the applicable post-grant audit requirements. - Regulatory Query Management: If the authority or Notified Body raises queries or observations, we assist with regulatory responses, document revisions and corrective actions.
- MD-6 Loan License Support: We support the applicant throughout the regulatory process leading to the applicable Form MD-6 loan licence, subject to fulfilment of the regulatory requirements.
Start Your Medical Device Manufacturing Journey
Looking to manufacture Class A or Class B medical devices in India without establishing your own manufacturing facility?
MDR Consultants can help you assess whether the MD-4 & MD-6 loan licence pathway is appropriate for your proposed medical device and manufacturing arrangement.
