The MD-5 Manufacturing License for Class A & B Medical Devices is required for eligible manufacturers intending to manufacture medical devices in India for sale or distribution. Under the Medical Devices Rules, 2017, eligible Class A and Class B manufacturers apply through Form MD-3, and the State Licensing Authority grants the manufacturing licence in Form MD-5 after the applicable regulatory requirements are satisfied.
ELT Corporate provides end-to-end support for MD-5 manufacturing licence applications — regulatory assessment, documentation, application preparation, online filing, compliance support and regulatory queries.
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MD-3 | Application for the manufacturing licence | gold
MD-5 | Manufacturing licence granted by the authority | orange
State Licensing Authority | Grants the licence for Class A and B | blue
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Quick Facts
| Particular | Details |
|---|---|
| Licence | MD-5 Manufacturing License |
| Applicable classes | Class A & Class B |
| Application form | Form MD-3 |
| Licence form | Form MD-5 |
| Licensing authority | State Licensing Authority |
| Regulatory framework | Medical Devices Rules, 2017 |
| Application portal | Applicable government online portal |
| Quality requirement | Quality Management System compliance |
| Purpose | Manufacturing for sale or distribution |
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The regulatory pathway for Class A and B manufacturing runs MD-3 to MD-5, with the licence issued by the State Licensing Authority.
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What is an MD-5 Manufacturing License?
An MD-5 Manufacturing License is the licence issued for manufacturing eligible Class A and Class B medical devices for sale or distribution in India.
The application is submitted in Form MD-3 to the State Licensing Authority along with the prescribed fee and required documentation. The applicant must demonstrate compliance with applicable requirements, including the Quality Management System requirements under the Medical Devices Rules, 2017.
The licence allows the approved manufacturing facility to manufacture the specified medical devices, subject to the conditions of the licence and applicable regulations.
What is CDSCO and Its Role in Medical Device Manufacturing?
The Central Drugs Standard Control Organisation (CDSCO) is India’s national regulatory authority for medical devices and other regulated products.
Medical devices in India are regulated under the Medical Devices Rules, 2017, which establish a risk-based framework. Devices are classified into Class A, B, C and D according to their associated risk.
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Class A and Class B manufacturing licences are handled by the State Licensing Authority, while higher-risk Class C and Class D manufacturing licences are handled by the Central Licensing Authority.
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Why is an MD-5 Manufacturing License Required?
Obtaining the applicable manufacturing licence helps manufacturers legally manufacture eligible medical devices for sale or distribution in India.
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Regulatory Compliance | Helps the manufacturer operate according to the applicable Medical Devices Rules. | file
Legal Manufacturing | Provides the regulatory authorisation for manufacturing covered Class A and B devices. | check
Quality Management | The application requires compliance with applicable Quality Management System requirements. | shield
Market Access | Supports lawful manufacturing and distribution of approved medical devices in India. | globe
Regulatory Documentation | Establishes a documented regulatory framework for the facility and its products. | search
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Which Medical Devices Come Under Class A & Class B?
Medical devices in India are classified according to risk.
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Class A | Low risk
Class B | Low to moderate risk
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Class A — low risk. Class A non-sterile and non-measuring medical devices are exempt from the licensing requirement under the applicable exemption notification.
Class B — low to moderate risk. Class B devices remain subject to the applicable manufacturing licensing requirements.
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The exact regulatory requirement should be checked against the current classification and applicable notifications for the particular device.
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Who Can Apply for an MD-5 Manufacturing License?
The service can be relevant to:
- Medical device manufacturers
- Indian medical device companies
- New medical device manufacturing businesses
- Existing manufacturers adding regulated medical devices
- Manufacturers producing Class A devices that are subject to licensing
- Class B medical device manufacturers
- Eligible applicants seeking to manufacture devices for sale or distribution
The applicant must have a suitable manufacturing facility and meet the applicable regulatory and quality requirements.
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Share your device details and our regulatory team will confirm the classification and the licence that applies.
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MD-5 Manufacturing License Process
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Medical device classification | Determine whether the product falls under Class A or Class B according to the applicable risk classification rules.
Regulatory assessment | Review the device, intended use, manufacturing process and applicable regulatory requirements.
Prepare documents | Prepare the required regulatory, technical, manufacturing and quality documents.
Prepare the MD-3 application | The manufacturing licence application for applicable Class A and B devices is made in Form MD-3.
Online submission | Submit the application and prescribed documents through the applicable government online system.
Regulatory review | The State Licensing Authority reviews the application and supporting documents.
Manufacturing site compliance | The premises must satisfy the applicable requirements, including Quality Management System requirements.
Grant of the MD-5 licence | Once the requirements are satisfactorily fulfilled, the authority may grant the licence in Form MD-5.
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Documents Required for MD-5 License
The exact documents can vary depending on the device and manufacturing setup, but the application generally requires regulatory, technical and quality-related information.
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- Company or firm details
- Applicant details
- Manufacturing facility address
- Ownership or constitution documents
- Authorised person’s details
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- Manufacturing site details
- Plant and site information
- Manufacturing area details
- Equipment and machinery details
- Manufacturing process information
- Quality control arrangements
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- Device name and generic name
- Intended use
- Device specifications
- Risk classification
- Product specifications
- Packaging information
- Labelling details
- Shelf-life information, where applicable
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- Quality Management System documentation
- Applicable standards
- Testing information
- Validation documents, where applicable
- Risk management documentation
- Technical documentation
- Other documents prescribed under the applicable regulatory framework
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The Medical Devices Rules require the application to be accompanied by the applicable documents specified in the Fourth Schedule, along with an undertaking regarding compliance with the Quality Management System requirements of the Fifth Schedule.
Quality Management System Requirements
Quality management is an important part of the Class A and Class B manufacturing licensing process. Manufacturers must comply with the applicable Quality Management System requirements specified under the Medical Devices Rules, 2017.
Depending on the device and regulatory requirements, this can involve:
- Quality procedures
- Manufacturing controls
- Quality control
- Process validation
- Equipment controls
- Risk management
- Documentation and record control
- Complaint handling
- Corrective and preventive actions
MD-5 License Timeline
The Medical Devices Rules specify a regulatory timeline for processing the Class A and B manufacturing application.
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45 days | To grant or reject the application
Form MD-3 | Application form
Form MD-5 | Licence granted
State Authority | Grants the licence
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For an eligible Class A or B application, the State Licensing Authority is required to grant or reject the licence, with reasons recorded, within 45 days from the date of application, subject to fulfilment of the applicable requirements.
For applicable Class A devices, the rules also provide for an audit of the manufacturing site by a registered Notified Body after the licence is granted, within the specified period. Actual completion time can vary depending on documentation, queries, compliance requirements and the specific device.
Government Fee for MD-5 License
The government fee for a manufacturing licence is prescribed under the Second Schedule of the Medical Devices Rules, 2017. The applicable amount can depend on the type and regulatory category of the device and other prescribed factors.
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Regulatory fees and notifications change from time to time. The applicable fee should be verified against the latest Second Schedule before filing.
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MD-5 vs MD-6 Manufacturing License
| MD-5 | MD-6 |
|---|---|
| Manufacturing licence | Loan manufacturing licence |
| Issued for manufacturing for sale or distribution | Issued as a loan licence |
| Application through Form MD-3 | Application through Form MD-4 |
| Applicable to eligible Class A and B devices | Applicable to eligible Class A and B devices |
The Medical Devices Rules identify MD-5 as the manufacturing licence and MD-6 as the loan licence for Class A and Class B medical devices.
Why Choose ELT Corporate?
ELT Corporate supports manufacturers through the MD-5 licensing process, from the initial regulatory assessment to application preparation and regulatory coordination.
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Classification Support | Medical device classification and MD-5 regulatory assessment. | search
Application Preparation | MD-3 application preparation and filing assistance. | file
Documentation | Documentation and technical documentation support. | check
Quality Compliance | Quality compliance guidance for the manufacturing facility. | shield
Query Handling | Regulatory query support until the licence is granted. | users
Post-Approval | Manufacturing licence compliance and post-approval assistance. | clock
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Frequently Asked Questions
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What is an MD-5 Manufacturing License? | MD-5 is the manufacturing licence issued for eligible Class A and Class B medical devices under the Medical Devices Rules, 2017.
What is the application form for MD-5? | The application for the applicable Class A and B manufacturing licence is made in Form MD-3. The licence itself is issued in Form MD-5.
Who issues the MD-5 License? | The State Licensing Authority issues the MD-5 manufacturing licence for eligible Class A and Class B medical devices.
Is MD-5 required for Class B medical devices? | Yes. Applicable Class B medical device manufacturing is subject to the prescribed manufacturing licensing requirements under the Medical Devices Rules, 2017.
Is MD-5 required for every Class A medical device? | Not necessarily. Class A non-sterile and non-measuring medical devices are exempt from the licensing requirement under the applicable notification.
What is the difference between MD-3 and MD-5? | MD-3 is the application form, whereas MD-5 is the manufacturing licence granted after the applicable requirements are satisfied.
Is ISO 13485 required for MD-5? | The manufacturer must comply with the applicable Quality Management System requirements under the Medical Devices Rules. The exact documentation and certification requirements should be assessed according to the device and applicable provisions.
How long does MD-5 approval take? | The rules provide a 45-day period for grant or rejection of the application, subject to fulfilment of the prescribed requirements.
Can ELT Corporate help with MD-5 registration? | Yes. ELT Corporate assists with classification, documentation, MD-3 application preparation, filing and regulatory compliance support.
What happens after obtaining an MD-5 License? | The manufacturer must continue complying with the conditions of the licence and applicable Medical Devices Rules, including quality, manufacturing, documentation and post-market requirements.
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Need an MD-5 Manufacturing License?
If you are planning to manufacture a Class A or Class B medical device in India, ELT Corporate can assist with the regulatory assessment, MD-3 application, documentation and the licensing process.
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Share your device details and our regulatory team will guide you through classification, documentation and filing.
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