Are you planning to manufacture Class C or Class D medical devices in India? If yes, obtaining a CDSCO MD-9 License is a mandatory regulatory requirement before manufacturing, selling, or distributing these high-risk medical devices. Under the Medical Devices Rules, 2017, manufacturers must obtain the MD-9 License from the Central Drugs Standard Control Organisation (CDSCO) after submitting an application in Form MD-7 and successfully completing document verification and facility inspection. Whether your manufacturing unit is located in Delhi, Noida, Gurgaon, Mumbai, Pune, Chennai, Hyderabad, Bengaluru, Ahmedabad, or anywhere in India, complying with CDSCO regulations is essential for legal market access. This guide explains the CDSCO MD-9 License, eligibility, registration process, required documents, government fees, compliance requirements, validity, and common mistakes to help manufacturers achieve faster approval in 2026.

What is a CDSCO MD-9 License?

A CDSCO MD-9 License is the manufacturing license issued by the Central Licensing Authority for the manufacture, sale, and distribution of Class C and Class D medical devices in India. It is issued after an application in Form MD-7 is reviewed and the manufacturing facility complies with the Medical Devices Rules, 2017.

Who Needs an MD-9 License?

Manufacturers producing Class C and Class D medical devices generally require an MD-9 License, including those manufacturing:

• Ventilators

• Dialysis equipment

• Infusion pumps

• MRI systems

• CT scanners

• Pacemakers

• Implantable medical devices

• High-risk diagnostic equipment

Benefits of Obtaining an MD-9 License

• Legal authorization to manufacture Class C & D medical devices

• Compliance with CDSCO regulations

• Improved customer confidence

• Easier participation in government tenders

• Better export opportunities

• Reduced regulatory risk

• Improved quality management

Eligibility Criteria

Applicants should generally have:

• A registered manufacturing company

• Manufacturing premises complying with applicable GMP and quality requirements

• Qualified technical personnel

• Quality Management System documentation

• Device Master File and Plant Master File

• Required infrastructure and testing facilities

Documents Required for MD-9 License

Prepare the following documents:

• Company Incorporation Certificate

• PAN & GST Registration

• Manufacturing Site Details

• Device Master File (DMF)

• Plant Master File (PMF)

• ISO 13485 Certificate (where applicable)

• Quality Management System documents

• List of Equipment

• Technical Staff Details

• Product Labels

• Risk Management Documents

• Clinical or performance evidence (where applicable)

• Authorization documents

Step-by-Step CDSCO MD-9 Registration Process

Step 1: Device Classification

Identify whether the product falls under Class C or Class D.

Step 2: Prepare Technical Documents

Compile the Device Master File, Plant Master File, quality documents, and supporting technical information.

Step 3: Submit Form MD-7

Submit the online application through the CDSCO Medical Device portal.

Step 4: Pay Government Fees

Pay the prescribed government fee based on the number of manufacturing sites and devices.

Step 5: CDSCO Review

The Central Licensing Authority reviews the submitted application and supporting documents.

Step 6: Manufacturing Site Inspection

CDSCO conducts an inspection of the manufacturing facility before granting approval for Class C and D devices.

Step 7: License Grant

After successful review and inspection, the manufacturing license is issued in Form MD-9.

Government Fees

Government fees depend on the number of manufacturing sites and medical devices covered by the application. Applicants should verify the latest fee schedule before submission.

Common Reasons for Application Rejection

• Incomplete documentation

• Incorrect device classification

• Missing technical data

• Poor Quality Management System

• Non-compliance during inspection

• Incorrect product labeling

• Delayed response to CDSCO queries

Compliance After Receiving MD-9 License

Manufacturers should continue to:

• Maintain quality records

• Report adverse events where required

• Follow labeling regulations

• Maintain manufacturing standards

• Cooperate with regulatory inspections

• Keep technical documentation updated

Why Choose PSR Compliance?

PSR Compliance offers complete assistance for:

• CDSCO Medical Device Registration

• MD-9 License Documentation

• Device Classification

• Technical File Preparation

• Application Filing

• Regulatory Support

• Query Resolution

• End-to-End Compliance Assistance

Frequently Asked Questions

What is the CDSCO MD-9 License?

The MD-9 License is the manufacturing license issued for Class C and Class D medical devices after approval of the MD-7 application.

Is the MD-9 License mandatory?

Yes, manufacturers of Class C and Class D medical devices generally require this license before commercial manufacturing.

Which authority issues the MD-9 License?

The Central Licensing Authority under CDSCO issues the MD-9 License.

Which form is used to apply?

Applications are submitted using Form MD-7, while the manufacturing license is issued in Form MD-9.

Can PSR Compliance assist with the process?

Yes. PSR Compliance provides complete support from documentation to regulatory approval.

Get Expert Assistance for CDSCO MD-9 License

Planning to manufacture Class C or Class D medical devices? Let PSR Compliance simplify your CDSCO approval process with expert regulatory guidance and end-to-end documentation support.

Conclusion

Obtaining a CDSCO MD-9 License is an essential regulatory requirement for manufacturers of Class C and Class D medical devices in India. The license ensures that your manufacturing facility complies with the Medical Devices Rules, 2017, helping you legally manufacture, market, and distribute high-risk medical devices while maintaining quality and safety standards. By understanding the eligibility criteria, documentation requirements, application process, and ongoing compliance obligations, businesses can avoid delays, penalties, and regulatory challenges.

If you are planning to apply for a CDSCO MD-9 License, partnering with experienced regulatory professionals can simplify the entire process. PSR Compliance offers end-to-end support for documentation, application filing, regulatory compliance, and CDSCO approvals, helping manufacturers obtain their licenses efficiently and focus on growing their business with confidence.

Company Name: PSR Compliance

Phone: +91 7065883416

Email: [email protected]

Office Address: D-49, D Block, Sector 6, Noida, Uttar Pradesh, 201301

Website: https://www.psrcompliance.com…