Manufacturing Licenses for Class C & D Medical Devices (Forms MD-7, MD-9)
Complete Guide to the MD-07 & MD-09 Manufacturing License ProcessPlanning to manufacture Class C or Class D medical devices in India?
Manufacturers of higher-risk medical devices must follow the applicable regulatory requirements under the Medical Devices Rules, 2017 (MDR 2017). For Class C and Class D medical devices, the manufacturing licence pathway is handled by the Central Licensing Authority (CLA).
The manufacturer applies in Form MD-7, and the manufacturing licence is granted in Form MD-9 after the applicable regulatory requirements have been satisfactorily completed.
At MDR Consultants, we assist medical device manufacturers with device classification, regulatory assessment, manufacturing facility readiness, Quality Management System documentation, Plant Master File, Device Master File, MD-7 application preparation, inspection readiness and regulatory query management.
What Is an MD-09 Manufacturing License?
Form MD-9 is the manufacturing licence issued for manufacturing Class C or Class D medical devices for sale or distribution in India.
The corresponding application is submitted in Form MD-7 through the applicable CDSCO online regulatory system.
The MD-9 licence identifies the manufacturer, manufacturing premises, approved medical devices and competent technical personnel responsible for manufacturing and testing. The licence remains subject to the provisions and conditions of the Medical Devices Rules, 2017.
Because Class C and Class D devices represent moderate-high-risk and high-risk categories, their manufacturing operations are subject to the applicable regulatory controls, quality requirements and inspection provisions.
Who Needs an MD-09 Manufacturing License?
The MD-09 manufacturing licence pathway applies to manufacturers intending to manufacture regulated Class C or Class D medical devices for sale or distribution in India.
This may include:
- New medical device manufacturers
- Existing manufacturers adding Class C or Class D devices
- Companies establishing a new medical device manufacturing facility
- Manufacturers expanding into higher-risk devices
- Contract or third-party manufacturers operating under an applicable regulatory arrangement
- Businesses developing advanced medical devices for the Indian market
The actual licensing requirements depend on the device, manufacturing activity and applicable provisions of the Medical Devices Rules.
MD-09 Manufacturing License Process in India
Determine Whether the Product Is a Medical Device
Before starting the licensing process, the manufacturer should establish whether the proposed product falls within the applicable definition of a medical device under Indian law.
The regulatory assessment should consider the product's:
• Intended purpose
• Mode of action
• Design and technical characteristics
• Medical claims
• Intended users
• Intended patient population
• Diagnostic, monitoring or therapeutic function
• Applicable regulatory provisions
A proper regulatory assessment at the beginning can help prevent an incorrect licensing pathway.
Determine the Applicable Risk Class
Once the product has been identified as a medical device, its applicable risk class should be determined.
For an MD-09 application, the device must fall within Class C or Class D under the applicable classification rules.
Classification can depend on factors including:
• Intended purpose
• Duration of use
• Invasiveness
• Implantation
• Patient contact
• Active or non-active nature
• Whether the device is intended for diagnosis, monitoring or treatment
• Potential risks associated with device failure
CDSCO maintains risk-based classification information for medical devices, and manufacturers should verify the current applicable classification before preparing the application.
Assess the Manufacturing Facility
A suitable manufacturing facility should be established and assessed before submission of the MD-7 application.
The facility should be appropriate for the proposed manufacturing activities and capable of meeting the applicable quality and regulatory requirements.
The assessment may cover:
• Manufacturing areas
• Facility layout
• Production rooms
• Equipment and machinery
• Utilities
• Environmental conditions
• Raw material storage
• Finished-product storage
• Quality control facilities
• Personnel facilities
• Testing arrangements
• Calibration systems
• Cleaning and sanitation
• Documentation systems
The CDSCO MD-9 checklist specifically calls for information concerning the manufacturing premises, plant layout, equipment and instruments, sanitation, production, quality assurance, storage and documentation.
Establish an Appropriate Quality Management System
Manufacturers must establish a Quality Management System appropriate to their medical device manufacturing activities.
The applicable requirements are linked to the Fifth Schedule of the Medical Devices Rules, 2017.
The QMS framework may address:
• Document control
• Record control
• Management responsibility
• Resource management
• Personnel competency
• Supplier controls
• Production controls
• Quality assurance
• Internal audits
• Non-conforming products
• Corrective and preventive actions
• Equipment maintenance
• Calibration
• Complaint handling
• Traceability
• Change management
The CDSCO MD-9 application checklist specifically includes an undertaking regarding compliance with the Fifth Schedule, along with Quality Manual, document and record controls, management responsibility, resource management, production controls, internal audit, non-conforming product controls and CAPA.
ISO 13485 for Medical Device Manufacturing
ISO 13485:2016 is widely used as a framework for medical device quality management.
However, manufacturers should distinguish between an ISO 13485 certification and the specific statutory requirements applicable under the Medical Devices Rules. The regulatory application should demonstrate compliance with the applicable MDR requirements rather than relying solely on an ISO certificate.
Prepare the Plant Master File
The Plant Master File (PMF) provides information about the manufacturing facility.
The CDSCO checklist refers to the Plant Master File in accordance with Appendix I of the Fourth Schedule of the Medical Devices Rules, 2017.
Depending on the applicable requirements, the PMF may cover:
• General information about the facility
• Manufacturing-site details
• Organization structure
• Personnel qualifications and responsibilities
• Premises and facilities
• Plant layout
• Equipment and instruments
• Sanitation
• Production activities
• Quality assurance
• Storage arrangements
• Documentation systems
A properly prepared PMF should accurately represent the actual manufacturing facility.
Prepare the Device Master File
The Device Master File (DMF) contains device-specific technical and regulatory information.
The CDSCO MD-9 checklist refers to the Device Master File in accordance with Appendix II of the Fourth Schedule.
Depending on the device, the documentation may include:
• Executive summary
• Device description
• Intended purpose
• Classification
• Device specifications
• Variants and accessories
• Materials
• Labelling
• Instructions for Use
• Design information
• Manufacturing information
• Risk management
• Verification and validation
• Performance information
• Testing information
• Applicable standards
• Packaging information
• Shelf-life information
• Sterilization information, where applicable
The precise documentation should be tailored to the specific device and regulatory pathway.
Prepare the MD-07 Application
The manufacturer submits the application for a Class C or Class D manufacturing licence in Form MD-7.
The application package should contain accurate and consistent information relating
to:
• Manufacturer
• Manufacturing premises
• Medical devices
• Device classification
• Technical documentation
• Quality Management System
• Plant Master File
• Device Master File
• Competent technical personnel
• Applicable declarations and undertakings
• Prescribed government fee
The CDSCO checklist identifies Form MD-7, fee challan, constitution of the firm, establishment/site ownership documents, Plant Master File, QMS information and Device Master File among the key components of a fresh MD-9 application.
Submit the Application Through the Applicable CDSCO Portal
The application is submitted through the applicable CDSCO online system with the required documents and prescribed fee.
Before submission, manufacturers should verify:
• Device classification
• Product names
• Manufacturing-site address
• Applicant details
• Technical documentation
• PMF and DMF consistency
• QMS documentation
• Personnel information
• Required declarations
• Fee details
Errors or inconsistencies across different parts of the application can result in regulatory queries and additional review.
Regulatory Review by the Central Licensing Authority
For Class C and Class D medical devices, the application is handled through the Central Licensing Authority
The regulatory review may consider:
• Manufacturer information
• Manufacturing premises
• Device classification
• Plant Master File
• Device Master File
• Quality Management System
• Manufacturing processes
• Testing arrangements
• Personnel
• Applicable standards
• Regulatory compliance
CDSCO's current medical device information identifies the CLA as the licensing authority for Class C and Class D manufacturing applications.
Manufacturing Facility Inspection
Inspection of the manufacturing site forms an important part of the Class C and Class D licensing process.
The inspection is intended to verify whether the manufacturing facility and quality systems are capable of meeting the applicable regulatory requirements.
Inspection areas may include:
• Premises
• Manufacturing operations
• Equipment
• Production controls
• Quality control
• Environmental conditions
• Personnel
• Training
• Calibration
• Storage
• Documentation
• Traceability
• Quality Management System
CDSCO has specific regulatory material addressing inspection of manufacturing sites for Class C and Class D medical devices under MDR 2017.
Respond to Regulatory Queries or Observations
During document review or inspection, the licensing authority may raise questions, observations or deficiencies.
The manufacturer may need to provide:
• Clarifications
• Additional documents
• Corrective action evidence
• Revised procedures
• Updated technical information
• Additional test reports
• Updated facility documentation
A structured response should directly address each observation and provide supporting evidence wherever required.
Grant of MD-09 Manufacturing License
Once the application, manufacturing facility and applicable compliance requirements are found satisfactory, the Central Licensing Authority grants the manufacturing licence in Form MD-09.
The MD-09 licence specifies the approved medical devices and manufacturing premises and identifies the competent technical staff responsible for manufacturing and testing.
The MD-09 licence specifies the approved medical devices and manufacturing premises and identifies the competent technical staff responsible for manufacturing and testing.
MD-09 Manufacturing License – Key Benefits
How MDR Consultants Can Help With MD-09 Licensing?
Obtaining a manufacturing licence for a Class C or Class D medical device requires coordination between regulatory, technical, quality and manufacturing requirements.
MDR Consultants provides end-to-end support for the applicable MD-07 and MD-09 licensing process.
- Device Classification Support: We assess the proposed device, intended purpose and applicable classification requirements to identify the appropriate regulatory pathway.
- Manufacturing Facility Assessment: We review the proposed manufacturing facility and identify potential gaps relating to infrastructure, equipment, personnel, production and quality systems.
- QMS Support: We assist manufacturers in developing and organizing documentation aligned with applicable Medical Devices Rules requirements.
- Plant Master File Preparation: We support the preparation of the Plant Master File covering the manufacturing facility, personnel, equipment, production, quality assurance, storage and documentation systems.
- Device Master File Support: We assist with compiling device-specific technical information, specifications, manufacturing details, labelling, risk management and applicable performance documentation.
- MD-07 Application Preparation: We help prepare, review and compile the MD-07 application and supporting regulatory dossier.
- Inspection Preparation: We help manufacturers prepare their manufacturing premises, documentation, personnel and quality systems for applicable regulatory inspection.
- Regulatory Query Management: If the authority raises observations or deficiencies, we assist with preparing responses, corrective actions and supporting documentation.
- MD-09 License Support: We provide regulatory support throughout the applicable licensing process leading to the MD-09 manufacturing licence, subject to fulfilment of the regulatory requirements.
Start Your Class C & Class D Medical Device Manufacturing Journey
MDR Consultants can support you from the initial regulatory assessment through MD-07 application preparation, technical documentation, facility readiness, inspection support and MD-09 manufacturing licence assistance.
