Medical Device Manufacturing Licence in India: Complete Process for MD-05 and MD-09 Under MDR 2017

Manufacturing medical devices in India requires compliance with the regulatory framework established under the Medical Devices Rules, 2017 (MDR 2017). Companies intending to manufacture medical devices for sale or distribution must obtain an appropriate manufacturing licence based on the risk classification of the device.

Under the MDR 2017 framework, the manufacturing licence is issued in Form MD-5 for Class A and Class B medical devices and in Form MD-9 for Class C and Class D medical devices. The application process, licensing authority, documentation, quality requirements, and inspection pathway depend primarily on medical device classification.

What Is a Medical Device Manufacturing Licence?

A medical device manufacturing licence is a regulatory authorization that permits a manufacturer to manufacture medical devices for sale or distribution in India.

The licence confirms that the manufacturing facility, quality systems, technical personnel, manufacturing processes, testing arrangements, and other applicable regulatory requirements meet the requirements prescribed under the Medical Devices Rules, 2017.

The licensing process is risk-based. This implies that regulatory requirements become more stringent as the potential risks associated with a medical device increase.

Under the CDSCO risk classification framework:

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

Therefore, the correct classification of the device is the first and one of the most important steps before applying for a manufacturing licence.

What is Form MD-05 (Class A & Class B Medical Devices)?

Form MD-5 is a manufacturing licence issued for the manufacture of Class A and Class B medical devices for sale or distribution.

The application for this licence is submitted in Form MD-3 to the applicable State Licensing Authority (SLA) through the prescribed online regulatory system.

For Class A and Class B devices, the applicant must demonstrate that the manufacturing site complies with the applicable requirements under MDR 2017. The manufacturing facility must have appropriate infrastructure, equipment, competent technical personnel, quality systems, manufacturing controls, and testing arrangements relevant to the medical devices being manufactured.

The applicable quality management system requirements must also be fulfilled in accordance with the requirements prescribed under the MDR 2017.

What Is Form MD-09?

Form MD-9 is a manufacturing licence issued for the manufacture of Class C and Class D medical devices for sale or distribution.

The application is submitted in Form MD-7 to the Central Licensing Authority (CLA) through a prescribed online regulatory system.

Because Class C and Class D devices are categorized as moderate-high-risk and high-risk devices, respectively, the regulatory evaluation is more rigorous. The applicant must provide comprehensive information regarding the manufacturing facility, quality management system, device specifications, manufacturing processes, personnel, equipment, testing arrangements, and other applicable technical and regulatory requirements of the facility.

The manufacturing licence in Form MD-9 is issued by the Central Licensing Authority after the application and applicable compliance requirements are assessed.

MD-5 vs MD-9: Key Difference

The correct form cannot be selected solely based on the product name. Medical devices must first be classified according to the applicable risk-based classification rules under the MDR 2017.

Step-by-Step Process for Obtaining a Medical Device Manufacturing Licence

Step 1: Determine the Correct Risk Classification

The first step is to determine whether a medical device falls under Class A, B, C, or D.

Classification should be determined based on the applicable classification rules under the First Schedule to the Medical Devices Rules, 2017, taking into account factors such as intended purpose, duration of use, invasiveness, anatomical contact, whether the device is active, and other relevant characteristics.

Incorrect classification may result in an incorrect regulatory pathway, incorrect application form, or delays in the licensing process.

Step 2: Prepare the Manufacturing Facility

The manufacturing site must be suitable for manufacturing the proposed medical devices.

The facility should have appropriate premises, manufacturing areas, equipment, utilities, storage arrangements, personnel, environmental controls (where applicable), and testing facilities or arrangements appropriate to the nature of the device.

The requirements may vary depending on the type of medical device and risk classification.

Step 3: Establish the Required Quality Management System

A suitable Quality Management System is an important part of the manufacturing licence process.

The manufacturer must establish documented procedures and controls covering relevant areas, such as:

• Document and record control
• Manufacturing and process controls
• Quality assurance
• Equipment and maintenance

• Personnel responsibilities
• Control of non-conforming products
• Corrective and preventive actions
• Internal audits
• Storage and handling
• Complaint handling and applicable post-market activities

Specific requirements must be addressed according to the applicable provisions of the MDR 2017 and relevant quality management system requirements.

Step 4: Prepare the Regulatory Documentation

The application should be supported by comprehensive and accurate documentation.

Depending on the device and application, the documentation may include the following:

• Application form and prescribed fee details
• Constitution of the firm
• Site ownership or tenancy documents
• Plant Master File
• Manufacturing site information
• Organisation chart and personnel details
• Qualifications and experience of technical staff
• Premises and facility information
• Plant layout
• Equipment and instrument details
• Manufacturing and testing procedures
• Quality Management System documentation
• Device Master File
• Product specifications
• Device description and intended use
• Labelling and Instructions for Use
• Risk management information
• Clinical or performance-related information, where applicable

The CDSCO checklists for manufacturing applications provide detailed document categories and technical information required for the respective application pathways.

Step 5: Submit the Application

For applicable Class A and Class B manufacturing applications, the applicant submits Form MD-3 for the grant of the licence in Form MD-5.

For Class C and Class D devices, the applicant submits Form MD-7 for the grant of the licence in Form MD-9.

The application is submitted through the prescribed online regulatory portal with the required supporting documents and the applicable fees.

Step 6: Regulatory Review, Audit, and Inspection

The Licensing Authority reviews the submitted applications and supporting documentation.

For Class A and Class B devices, the applicable quality management system audit requirements involving a registered Notified Body apply as prescribed under MDR 2017.

For Class C and Class D devices, the Central Licensing Authority may evaluate the manufacturing site and conduct or arrange inspections, as applicable, to assess compliance with the required regulatory and quality standards.

Applicants may be required to respond to queries or provide additional information during the review process.

Step 7: Grant of Manufacturing Licence

Once the Licensing Authority is satisfied that the applicable requirements have been fulfilled, the manufacturing licence may be granted.

The licence is issued in:

• Form MD-5 for Class A and Class B medical devices
• Form MD-9 for Class C and Class D medical devices

The licence is subject to the provisions and conditions of the Medical Devices Rules, 2017.

Important Compliance After Obtaining the Licence

Obtaining a manufacturing licence does not end the regulatory responsibilities of the manufacturer.

The licence holder must continue to comply with the applicable requirements of the MDR 2017 and the conditions of the licence. This includes maintaining the Quality Management System, controlling manufacturing activities, maintaining required records, ensuring product conformity, handling complaints, managing non-conformities, and fulfilling applicable post-market obligations.

Manufacturers must also ensure that any changes to the manufacturing site, products, processes, quality systems, or other approved information are managed in accordance with the applicable regulatory requirements. Certain changes may require prior approval, whereas others may need to be reported within prescribed timelines.

The licence holder may also be subject to regulatory inspections to verify continued compliance.

Validity of MD-5 and MD-9 Manufacturing Licences

Manufacturing licences issued in Form MD-5 and Form MD-9 are generally valid in perpetuity, subject to the payment of the applicable licence retention fee within the prescribed period and continued compliance with the MDR 2017.

Failure to comply with applicable legal requirements or licence conditions may result in regulatory action, including suspension or cancellation of the licence.

Conclusion

Obtaining a medical device manufacturing licence in India requires a structured regulatory approach. The process begins with the correct device classification and continues through facility preparation, quality management system implementation, technical documentation, online application, regulatory review, audit or inspection, and ongoing compliance.

For Class A and Class B medical devices, a manufacturing licence is issued in Form MD-5, following application in Form MD-3 to the applicable State Licensing Authority. For Class C and Class D medical devices, a manufacturing licence is issued in Form MD-9, following application in Form MD-7 to the Central Licensing Authority.

A complete and accurate application, supported by appropriate technical documentation and a compliant manufacturing facility, can help reduce avoidable regulatory delays and support a smoother licensing process under the Medical Device Rules, 2017.

Manufacturers planning to establish or expand medical device manufacturing operations in India should evaluate the applicable classification, licensing authority, documentation requirements, quality management obligations, and post-licensing responsibilities before initiating the application process.

Last Updated : 31 Aug 2026