MD-7 Manufacturing License for Class C & D Medical Devices

The MD-7 Manufacturing License for Class C & D Medical Devices is required for manufacturers seeking approval to manufacture higher-risk medical devices in India for sale or distribution.

Under the Medical Devices Rules, 2017, Class C and Class D medical devices are regulated through the Central Licensing Authority (CLA). The manufacturer submits the application in Form MD-7, and after fulfilling the applicable regulatory requirements, the manufacturing licence is issued in Form MD-9.

ELT Corporate provides end-to-end assistance for MD-7 applications — device classification, documentation, technical requirements, quality management compliance, application filing, regulatory queries and licensing support.

• MD-7Application for the manufacturing licence
• MD-9Manufacturing licence granted by the authority
• Central Licensing AuthorityGrants the licence for Class C and D

Quick Facts

Particular	Details
Application form	Form MD-7
Licence form	Form MD-9
Applicable classes	Class C & Class D
Licensing authority	Central Licensing Authority
Regulatory framework	Medical Devices Rules, 2017
Site evaluation	Manufacturing site evaluation or audit applies
Key files	Plant Master File and Device Master File
Quality requirement	Quality Management System compliance
Purpose	Manufacturing for sale or distribution

What is an MD-7 Manufacturing License?

MD-7 is the prescribed application form for obtaining a manufacturing licence for Class C and Class D medical devices. Manufacturers intending to manufacture these devices for sale or distribution in India must submit the required information and documents through the applicable regulatory process.

After review and satisfaction of the applicable requirements, the manufacturing licence is granted in Form MD-9.

The application may involve information relating to:

• Manufacturer details and manufacturing premises
• Medical device details, classification and intended use
• Manufacturing process
• Quality Management System
• Technical documentation, testing and validation
• Labelling, packaging and risk management

What are Class C & Class D Medical Devices?

Medical devices in India are classified according to their associated risk.

• Class CModerate to high risk
• Class DHigh risk

Class C represents devices with a moderate-to-high level of risk. These devices require appropriate regulatory controls covering manufacturing, quality, technical documentation and safety.

Class D represents high-risk medical devices and is subject to the highest level of regulatory control within the risk classification system.

Who Issues the Manufacturing License for Class C & D?

For Class C and Class D medical devices, the manufacturing licensing process is handled by the Central Licensing Authority. The basic regulatory pathway is:

1. MD-7 applicationThe manufacturer applies for the manufacturing licence.
2. Regulatory reviewThe Central Licensing Authority reviews the application and documents.
3. Site evaluation or auditThe manufacturing facility is evaluated as per applicable requirements.
4. MD-9 manufacturing licenceThe licence is granted once the requirements are fulfilled.

This differs from the Class A and B pathway, where the manufacturing licence is issued by the State Licensing Authority.

Why is an MD-7 Manufacturing License Required?

An MD-7 application is an important part of the regulatory process for manufacturers of Class C and D medical devices.

• Regulatory ComplianceHelps establish compliance with the applicable medical device requirements.
• Lawful ManufacturingSupports lawful manufacturing for sale or distribution in India.
• Structured ProcessProvides a structured licensing process from application to grant.
• Quality ControlsRequires appropriate quality controls across the facility.
• Facility AssessmentSupports assessment of the manufacturing facility.
• DocumentationEstablishes technical and product documentation for the device.

Manufacturers must continue complying with the applicable conditions of the licence and regulatory requirements after approval.

Who Can Apply for an MD-7 License?

The MD-7 manufacturing licence process may be relevant to:

• Indian medical device manufacturers
• Medical device manufacturing companies
• New medical device manufacturers
• Class C medical device manufacturers
• Class D medical device manufacturers
• Existing manufacturers adding new Class C or D devices
• Companies establishing a new manufacturing facility

The applicant must have the appropriate manufacturing infrastructure and comply with applicable quality and regulatory requirements.

MD-7 Manufacturing License Process

1. Identify the classificationDetermine whether the device falls under Class C or Class D according to the applicable rules.
2. Regulatory assessmentReview the intended use, design, technology, risk level, manufacturing process and specifications.
3. Prepare required documentsPrepare company, facility, quality, technical and device-related documents.
4. Prepare the MD-7 applicationCompile the application in Form MD-7 with the required information and supporting documents.
5. Submit the applicationFile through the applicable online system along with the prescribed government fee.
6. Regulatory reviewThe Central Licensing Authority reviews the application and technical information.
7. Manufacturing site evaluationThe facility may be evaluated or audited as per applicable requirements.
8. Respond to queriesProvide clarification or additional documentation against any observation raised.
9. Grant of the MD-9 licenceThe manufacturing licence is granted in Form MD-9 once requirements are fulfilled.

Documents Required for MD-7 Manufacturing License

The exact documentation depends on the medical device, manufacturing process and applicable requirements.

Plant Master File for MD-7 Application

The Plant Master File (PMF) provides information about the manufacturing facility. It can include details regarding:

• 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

A properly prepared Plant Master File helps present the manufacturing facility and its quality systems in a structured manner.

Device Master File for Class C & D Devices

The Device Master File (DMF) contains the technical and regulatory information about the 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 information
• 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 manufacturing medical devices. Manufacturers should establish appropriate procedures covering areas such as:

• 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 applicable requirements should be assessed according to the device and the Medical Devices Rules.

MD-7 Manufacturing License Timeline

The regulatory timeline can depend on the completeness of the application, technical review, manufacturing site evaluation, regulatory queries and the manufacturer’s response.

The Medical Devices Rules provide timelines for regulatory scrutiny, but the overall time to obtain the manufacturing licence can vary depending on the specific application and compliance requirements. Manufacturers should therefore ensure that documentation and the manufacturing facility are prepared before submitting the application.

Government Fee for MD-7 Manufacturing License

The applicable government fee is prescribed under the relevant provisions of the Medical Devices Rules, 2017, including the applicable fee schedule. The amount may depend on the regulatory requirements and device details.

MD-7 vs MD-9

MD-7	MD-9
Application form	Manufacturing licence
Used to apply for Class C and D manufacturing	Issued after applicable requirements are fulfilled
Submitted by the manufacturer	Granted by the Central Licensing Authority
Application stage	Licence stage
Contains regulatory and technical information	Authorises the applicable manufacturing activity

MD-7 is the application, while MD-9 is the manufacturing 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
Manufacturing licence pathway	Loan manufacturing pathway
Licence is issued in MD-9	Loan licence is issued in MD-10

Why Choose ELT Corporate for MD-7 License?

ELT Corporate helps medical device manufacturers navigate the regulatory process for the MD-7 Manufacturing License for Class C and D medical devices.

• Classification and AssessmentMedical device classification assistance and regulatory assessment.
• Application PreparationMD-7 application preparation and online filing assistance.
• Master FilesPlant Master File and Device Master File support.
• QMS and TechnicalQMS documentation and technical documentation support.
• Audit ReadinessManufacturing facility compliance guidance and audit preparation.
• Licensing and BeyondMD-9 licensing assistance and post-licence compliance guidance.

Our objective is to make the medical device manufacturing licensing process more structured and easier for manufacturers.

Frequently Asked Questions

• What is an MD-7 Manufacturing License?

  MD-7 is the application form used to apply for a manufacturing licence for Class C and Class D medical devices in India.

• Is MD-7 the actual manufacturing licence?

  No. MD-7 is the application form. MD-9 is the manufacturing licence issued after the applicable regulatory requirements are fulfilled.

• Who issues the MD-9 licence?

  The Central Licensing Authority is responsible for the manufacturing licensing of Class C and Class D medical devices.

• Which devices require an MD-7 application?

  The MD-7 application is used for manufacturing Class C and Class D medical devices intended for sale or distribution in India.

• What is the difference between Class C and Class D devices?

  Class C devices are categorised as moderate-to-high-risk devices, while Class D devices are categorised as high-risk devices.

• What documents are required for MD-7?

  Documents may include company details, manufacturing facility information, Plant Master File, Device Master File, QMS documents, technical documentation, risk management information, labelling and applicable testing or validation documents.

• Is a manufacturing-site audit required?

  The Class C and D manufacturing licensing process includes applicable manufacturing site evaluation and audit requirements.

• How long does an MD-7 application take?

  The overall timeline depends on the application, document completeness, regulatory review, site evaluation, observations and responses, so a single fixed approval timeline should not be relied upon.

• Can ELT Corporate help with MD-7 registration?

  Yes. ELT Corporate assists with classification, documentation, MD-7 application preparation, QMS requirements, technical documentation and regulatory coordination.

• What is an MD-9 Manufacturing License?

  MD-9 is the manufacturing licence issued for applicable Class C and Class D medical devices after the prescribed requirements are fulfilled.

Need an MD-7 Manufacturing License?

If you are planning to manufacture Class C or Class D medical devices in India, ELT Corporate can assist with the MD-7 application, technical documentation, QMS requirements, manufacturing facility compliance and the regulatory process.