Medical Device Manufacturing Licence in India is an important regulatory requirement for companies manufacturing medical devices, diagnostic equipment, surgical products, implants, hospital equipment, monitoring devices, in-vitro diagnostic products, and other regulated medical technologies for sale or distribution in India.

Medical devices in India are regulated under the Medical Devices Rules, 2017 (MDR 2017). The licensing pathway depends mainly on the risk classification of the medical device.

CDSCO classifies medical devices into four risk categories:

• Class A - Low Risk
• Class B - Low Moderate Risk
• Class C - Moderate High Risk
• Class D - High Risk

For manufacturing, Class A and Class B devices generally fall under the State Licensing Authority, while Class C and Class D manufacturing licences are handled by the Central Licensing Authority. A special registration route applies to Class A non-sterile and non-measuring medical devices, which are exempt from the normal manufacturing licensing regime.

A Medical Device Manufacturing Licence Consultant can help businesses classify the device, identify the correct licence form, prepare technical documentation, establish the Quality Management System, coordinate audits or inspections, file the application, respond to regulatory queries, and obtain the applicable manufacturing licence.

What is a Medical Device Manufacturing Licence?

A Medical Device Manufacturing Licence permits an eligible manufacturer to manufacture specified medical devices for sale or distribution in India.

The applicable licence depends on the device classification.

The basic regulatory structure is:

Class A / Class B → State Licensing Authority

Class C / Class D → Central Licensing Authority

The forms also vary according to the risk class and whether the applicant needs a regular manufacturing licence or a loan licence.

Medical Device Classification in India

Correct classification is the first step before preparing a licence application.

The four categories are based on risk:

Medical Device ClassRisk LevelManufacturing AuthorityClass ALow RiskState Licensing Authority / registration route for qualifying non-sterile, non-measuring devicesClass BLow-Moderate RiskState Licensing AuthorityClass CModerate-High RiskCentral Licensing AuthorityClass DHigh RiskCentral Licensing AuthorityClassification depends on factors such as:

• Intended use
• Duration of contact
• Invasiveness
• Implantation
• Active or non-active nature
• Anatomical location
• Diagnostic or therapeutic purpose
• Risk to patient
• Whether the product is an IVD

Businesses should confirm the classification before investing in regulatory documentation.

Class A Non-Sterile and Non-Measuring Medical Devices

An important exception applies to Class A medical devices that are both non-sterile and non-measuring.

These devices were exempted from the normal manufacturing licensing requirement through the 2022 amendment to the Medical Devices Rules.

Instead of obtaining an MD-5 manufacturing licence, manufacturers of qualifying Class A non-sterile and non-measuring devices register through the Online System for Medical Devices.

The registration process requires information such as:

• Manufacturing site details
• Generic device name
• Brand name
• Model
• Intended use
• Material of construction
• Dimensions, where applicable
• Shelf life, where applicable
• Self-certification of conformity with Essential Principles
• Undertaking regarding classification and compliance

A registration number is generated after the required information is submitted.

Businesses should therefore first determine whether their Class A device falls under this simplified route.

Manufacturing Licence for Class A and Class B Medical Devices

For applicable Class A devices other than non-sterile and non-measuring Class A devices, and for Class B devices, the application is made to the State Licensing Authority.

The relevant forms are:

Form MD-3 → Application for Manufacturing Licence

Form MD-5 → Manufacturing Licence

For a loan licence:

Form MD-4 → Application for Loan Licence

Form MD-6 → Loan Licence

The Medical Devices Rules require applications to be filed through the identified online system along with the applicable fees and documents specified under the Fourth Schedule.

Manufacturing Licence for Class C and Class D Medical Devices

Higher-risk Class C and Class D medical devices are regulated through the Central Licensing Authority.

The relevant forms are:

Form MD-7 → Application for Manufacturing Licence

Form MD-9 → Manufacturing Licence

For a loan licence:

Form MD-8 → Application for Loan Licence

Form MD-10 → Loan Licence

CDSCO's current medical-device information confirms the MD-7/MD-8 to MD-9/MD-10 route for manufacturing Class C and Class D devices.

These applications generally involve greater technical scrutiny and manufacturing-site inspection because of the higher risk associated with the products.

What is a Medical Device Loan Licence?

A loan licence allows a company to manufacture its medical devices using the manufacturing facilities of another licensed manufacturer, subject to the applicable regulatory requirements.

The forms are:

• MD-4 → MD-6 for Class A and B
• MD-8 → MD-10 for Class C and D

A loan licence may be useful for:

• Medical device startups
• Brand owners
• Companies without their own factory
• Businesses outsourcing production
• Companies launching a new medical device
• Manufacturers testing market demand before building their own plant

The manufacturing facility used under the arrangement must meet the applicable Quality Management System and regulatory requirements.

Role of Medical Device Manufacturing Licence Consultant

A consultant can assist manufacturers with:

• Medical device classification
• Regulatory applicability assessment
• Manufacturing licence pathway
• MD-3 application
• MD-4 loan licence application
• MD-7 application
• MD-8 loan licence application
• Class A registration assessment
• Device Master File preparation
• Plant Master File preparation
• Quality Management System review
• Essential Principles checklist
• Technical documentation
• Product testing requirements
• Manufacturing-site readiness
• Notified Body audit preparation
• CDSCO or SLA inspection support
• Regulatory query response
• Product addition
• Post-approval change support
• Licence retention compliance

The regulatory strategy should be finalised before submitting the application.

Documents Required for Medical Device Manufacturing Licence

The exact documentation depends on device classification and application type.

Common documentation may include:

• Company incorporation documents
• PAN
• GST Registration
• Factory address documents
• Land ownership or lease documents
• Manufacturing-site layout
• Plant Master File
• Device Master File
• Manufacturing process
• Process flow diagram
• Machinery and equipment list
• Testing equipment list
• Quality Management System documents
• Essential Principles checklist
• Product specifications
• Intended use
• Risk analysis
• Design and development information
• Product labels
• Instructions for use
• Shelf-life data, where applicable
• Sterilisation validation, where applicable
• Performance data
• Biocompatibility information, where applicable
• Qualified technical staff details
• Applicable test reports
• Other documents required under MDR 2017

Documentation should reflect the actual medical device and manufacturing facility.

Plant Master File

The Plant Master File provides information about the manufacturing facility and its quality system.

It may cover:

• Manufacturing-site details
• Organisation structure
• Personnel
• Premises
• Manufacturing areas
• Equipment
• Quality control
• Storage
• Documentation systems
• Validation
• Complaint handling
• Recall procedures
• Internal audits

The manufacturing site described in the application should match actual factory operations.

Device Master File

The Device Master File contains detailed technical information about the proposed medical device.

Depending on the device, it may include:

• Device description
• Intended use
• Product specifications
• Design information
• Raw materials
• Manufacturing process
• Risk analysis
• Essential Principles
• Verification and validation
• Performance data
• Biocompatibility
• Sterilisation information
• Shelf-life data
• Labels
• Instructions for use

Higher-risk devices generally require more extensive technical documentation.

Quality Management System for Medical Device Manufacturing

Medical device manufacturers are required to maintain a Quality Management System in accordance with the applicable requirements of the Medical Devices Rules.

The application for Class A and B devices includes an undertaking confirming compliance with the QMS requirements specified in the Fifth Schedule.

A QMS may cover areas such as:

• Design control
• Document control
• Supplier control
• Raw-material inspection
• Manufacturing controls
• Quality testing
• Calibration
• Validation
• Product release
• Complaint handling
• Corrective and preventive action
• Recall procedures
• Internal audit
• Training
• Traceability

Manufacturers commonly align their systems with ISO 13485 principles, but the regulatory licence requirements under MDR 2017 must still be independently satisfied.

Medical Device Manufacturing Licence Process

A typical manufacturing licence process can be understood in the following steps.

Step 1: Confirm Whether the Product is a Medical Device

The first step is determining whether the proposed product falls within the medical-device regulatory framework.

Products should be reviewed based on:

• Intended medical purpose
• Claims
• Mode of action
• User
• Patient contact
• Diagnostic or therapeutic purpose

Step 2: Determine Medical Device Classification

The product is classified as:

Class A → Class B → Class C → Class D

The risk classification determines the licensing authority, application form, audit route, and level of technical documentation.

Step 3: Identify the Correct Application

Depending on classification:

Class A/B Manufacturing → MD-3

Class A/B Loan Licence → MD-4

Class C/D Manufacturing → MD-7

Class C/D Loan Licence → MD-8

Class A non-sterile and non-measuring devices should be assessed for the registration route instead.

Step 4: Prepare QMS and Manufacturing Facility

Before application, the manufacturing facility should be reviewed for:

• Suitable manufacturing space
• Equipment
• Quality-control facilities
• Testing equipment
• Personnel
• Storage
• Documentation
• Calibration
• Cleanliness controls
• Environmental controls, where required
• Traceability

Gaps should preferably be corrected before regulatory audit or inspection.

Step 5: Prepare Technical Documentation

The manufacturer prepares the Plant Master File, Device Master File, Essential Principles checklist, QMS documentation, product specifications, labelling documents, and other applicable information.

Step 6: Submit Online Application

The application is submitted through the identified medical-device online system with the applicable government fee and supporting documents.

Step 7: Audit or Inspection

Audit requirements depend on the device class.

For applicable Class A and Class B manufacturing sites, registered Notified Bodies play an important role in manufacturing-site audits.

For Class A devices under the licensing route, the rules allow the licence to be granted before the audit, with the required Notified Body audit to follow within the prescribed period.

Class B sites are audited as part of the licensing process.

Class C and Class D applications involve scrutiny and inspection under the Central Licensing Authority framework.

Step 8: Respond to Regulatory Queries

Queries may relate to:

• Device classification
• Device Master File
• QMS
• Testing
• Risk analysis
• Labels
• Manufacturing process
• Validation
• Technical personnel
• Factory facilities
• Product specifications

Responses should directly address each observation and provide supporting documentation.

Step 9: Grant of Manufacturing Licence

After satisfactory review, the applicable authority may issue:

• MD-5 for Class A/B manufacturing
• MD-6 for Class A/B loan licence
• MD-9 for Class C/D manufacturing
• MD-10 for Class C/D loan licence

Only products and manufacturing sites covered by the approved licence should be manufactured under that licence.

Government Fees for Medical Device Manufacturing Licence

Under the fee schedule in the Medical Devices Rules, the basic government fees are:

Class A or Class B

• ₹5,000 for one manufacturing site
• ₹500 for each distinct medical device

Class C or Class D

• ₹50,000 for one manufacturing site
• ₹1,000 for each distinct medical device

The same schedule also provides corresponding retention fees.

Professional consulting, testing, Notified Body audits, validation, and other project expenses are separate.

Medical Device Manufacturing Licence Timeline

Processing time depends on device class, audit, documentation quality, regulatory queries, and inspection readiness.

CDSCO's published timelines provide indicative regulatory milestones such as:

• Class A licence under the licensing route - approximately 45 working days for grant, followed by the required Notified Body audit within 120 days
• Class B - Notified Body audit, reporting, and State Licensing Authority review
• Class C/D - scrutiny, inspection, and subsequent licence decision through the Central Licensing Authority process

The published timelines exclude additional time caused by applicant queries or incomplete documentation.

Businesses should therefore avoid committing to commercial launch dates before understanding the complete approval pathway.

Validity of Medical Device Manufacturing Licence

Manufacturing licences under the Medical Devices Rules are generally valid in perpetuity, unless suspended, cancelled, or surrendered, subject to payment of the prescribed licence retention fee after every five-year period.

The Rules also provide for late fees where the retention fee is not paid within the required timeline.

Manufacturers should therefore maintain a regulatory calendar even though the licence does not follow a traditional short-term expiry model.

Test Licence for Medical Device Manufacturing

A company that needs to manufacture a small quantity of medical devices for:

• Testing
• Evaluation
• Clinical investigation
• Examination
• Demonstration
• Training

may need a test manufacturing licence.

The application is made in Form MD-12, and the licence is granted in Form MD-13 subject to applicable requirements.

This route is different from the commercial manufacturing licence.

Manufacturing Licence for New or Investigational Medical Devices

Devices without a predicate device may require additional regulatory permissions before commercial manufacturing.

Depending on the product, the manufacturer may need:

• Clinical investigation
• Performance evaluation
• Safety and performance data
• Permission from the Central Licensing Authority

Manufacturers developing innovative devices should therefore determine the regulatory pathway before directly applying for a standard manufacturing licence.

Addition of New Medical Devices to Existing Licence

Existing manufacturers may later want to add:

• New medical device
• New model
• New intended use
• Additional device category
• New product range

CDSCO confirms that additional medical devices can be added to an existing manufacturing licence through an endorsement application with the applicable fee and supporting documents.

Manufacturers should obtain the required approval before commercial manufacture of additional products.

Post-Approval Changes

Changes after licence approval should be reviewed from a regulatory perspective.

Examples can include:

• Change in manufacturing process
• Change in manufacturing site
• Major equipment changes
• Design changes
• Change in intended use
• Quality-system changes
• New sterilisation method
• Change in critical raw material

Some changes may require prior approval, while others may follow the applicable notification or documentation procedure.

Regulatory review should therefore be completed before implementing a significant change.

Medical Device Labelling Requirements

Manufacturers should also ensure that medical device labels comply with the applicable MDR requirements.

Depending on the device, labels may need information relating to:

• Device name
• Manufacturer
• Manufacturing address
• Batch or lot number
• Serial number, where applicable
• Manufacturing date
• Expiry date, where applicable
• Sterile status
• Storage conditions
• Intended use
• Warnings
• Manufacturing licence or registration details, as applicable

Labelling should be reviewed before printing commercial quantities.

Common Mistakes in Medical Device Manufacturing Licence Applications

Common problems include:

• Incorrect medical device classification
• Filing under the wrong form
• Assuming every Class A device requires MD-5
• Incomplete Device Master File
• Weak Plant Master File
• Missing QMS procedures
• Incomplete risk analysis
• Missing validation
• Incorrect product label
• Factory not ready for audit
• Testing equipment not calibrated
• Manufacturing process different from submitted documents
• Missing technical personnel
• Starting commercial production before approval
• Adding new devices without endorsement

A pre-application gap assessment can help reduce these problems.

Benefits of Hiring Medical Device Manufacturing Licence Consultant

Professional consulting can help manufacturers with:

• Medical device classification
• Regulatory pathway assessment
• Class A registration
• MD-3 / MD-5 licensing
• MD-4 / MD-6 loan licensing
• MD-7 / MD-9 licensing
• MD-8 / MD-10 loan licensing
• QMS preparation
• Plant Master File
• Device Master File
• Essential Principles
• Audit readiness
• Inspection support
• Regulatory query response
• Product addition
• Post-approval compliance

This can be particularly useful for startups and manufacturers entering the regulated medical-device sector for the first time.

Why Choose Green Permits for Medical Device Manufacturing Licence?

Green Permits Consulting supports manufacturers, healthcare businesses, startups, importers, and industrial companies with regulatory approvals and manufacturing compliance in India.

Green Permits can assist with:

• Medical Device Manufacturing Licence
• Medical Device Classification
• Class A Device Registration
• MD-3 / MD-5 Application
• MD-7 / MD-9 Application
• Medical Device Loan Licence
• QMS Documentation
• Plant Master File
• Device Master File
• Audit and Inspection Preparation
• CDSCO Query Response
• Product Addition
• Post-Approval Compliance
• CDSCO Import and Regulatory Support

The objective is to help manufacturers establish the correct regulatory pathway from device classification and factory preparation to licence approval and ongoing compliance.

Learn More About Medical Device Manufacturing Licence in India

Before manufacturing medical devices in India, confirm the device classification and applicable licence requirements to plan your facility, documentation, testing, audits, fees, and approvals.

Read more about medical device licensing and regulatory compliance services here:

👉 https://www.greenpermits.in/08/cdsco-medical-device-manufacturing-licence-india/

📞 Get Expert Assistance for Medical Device Manufacturing Licence

If you need help with Medical Device Manufacturing Licence in India, device classification, MD-3, MD-5, MD-7, MD-9, loan licence, Class A registration, QMS documentation, factory audit preparation, or regulatory filing, Green Permits Consulting can assist you.

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