MD-5 Manufacturing License for Class A & B

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.

• MD-3Application for the manufacturing licence
• MD-5Manufacturing licence granted by the authority
• State Licensing AuthorityGrants the licence for Class A and B

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

The regulatory pathway for Class A and B manufacturing runs MD-3 to MD-5, with the licence issued by the State Licensing Authority.

— Medical Devices Rules, 2017

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.

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.

• Regulatory ComplianceHelps the manufacturer operate according to the applicable Medical Devices Rules.
• Legal ManufacturingProvides the regulatory authorisation for manufacturing covered Class A and B devices.
• Quality ManagementThe application requires compliance with applicable Quality Management System requirements.
• Market AccessSupports lawful manufacturing and distribution of approved medical devices in India.
• Regulatory DocumentationEstablishes a documented regulatory framework for the facility and its products.

Which Medical Devices Come Under Class A & Class B?

Medical devices in India are classified according to risk.

• Class ALow risk
• Class BLow to moderate risk

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.

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.

MD-5 Manufacturing License Process

1. Medical device classificationDetermine whether the product falls under Class A or Class B according to the applicable risk classification rules.
2. Regulatory assessmentReview the device, intended use, manufacturing process and applicable regulatory requirements.
3. Prepare documentsPrepare the required regulatory, technical, manufacturing and quality documents.
4. Prepare the MD-3 applicationThe manufacturing licence application for applicable Class A and B devices is made in Form MD-3.
5. Online submissionSubmit the application and prescribed documents through the applicable government online system.
6. Regulatory reviewThe State Licensing Authority reviews the application and supporting documents.
7. Manufacturing site complianceThe premises must satisfy the applicable requirements, including Quality Management System requirements.
8. Grant of the MD-5 licenceOnce the requirements are satisfactorily fulfilled, the authority may grant the licence in Form MD-5.

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.

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.

• 45 daysTo grant or reject the application
• Form MD-3Application form
• Form MD-5Licence granted
• State AuthorityGrants the licence

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.

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.

• Classification SupportMedical device classification and MD-5 regulatory assessment.
• Application PreparationMD-3 application preparation and filing assistance.
• DocumentationDocumentation and technical documentation support.
• Quality ComplianceQuality compliance guidance for the manufacturing facility.
• Query HandlingRegulatory query support until the licence is granted.
• Post-ApprovalManufacturing licence compliance and post-approval assistance.

Frequently Asked Questions

• 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.

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.