Manufacturing License for Sale or for Distribution of Medical Devices in India: MD-3, MD-5, MD-7, and MD-9 Made Simple

India’s Medical Device manufacturing sector is growing rapidly, driven by a combination of government policy, the Make in India initiative, and increasing global demand for cost-effective, high-quality medical products. For any company wishing to manufacture Medical Devices in India — whether domestic or foreign — obtaining the correct manufacturing license from CDSCO is the essential first step.

The manufacturing license framework under MDR 2017 uses four primary application forms: MD-3, MD-5, MD-7, and MD-9 based on the risk classification of the device. This article explains what each form covers, what documents are required, and what manufacturers need to know to navigate the process efficiently.

Overview of the Manufacturing License Framework

Under MDR 2017, manufacturing licenses for Medical Devices are granted by CDSCO at the central level by Central Licensing Authorities (CLAs) for Class C and D (higher-risk) devices, and by State Licensing Authorities (SLAs) for Class A and B (lower-risk) devices. The forms vary based on this split:

Table1

MD-3: Application for Grant of License to Manufacture for Sale or for Distribution of Class A and B Medical Devices

Who Applies?

Any company intending to manufacture Class A (lowest risk) and Class B (low-moderate risk) Medical Devices in India must apply for a manufacturing license through Form MD-3 and submit the application to the CDSCO MD Portal.

Key Requirements

• Completed Form MD-3
• Details of the manufacturing site — General Information such as Name, address, manufacturing activities, Personnel, Premises and Facilities, Equipment, Sanitation, Storage, Documentation, Contract Activities, etc.
• Device Master File containing product details such as Device Description, Labelling, EPC, Risk Management Data, Verification and Validation data, Biocompatibility, Stability data, Clinical Evidence, Sterilization data, PMS data, etc.
• Quality Management System (QMS) documentation — ISO 13485 certification is strongly recommended and often required in practice.
• Design and Manufacturing Information
• Performance Evaluation Report (IVDs Only).

Process and Timelines

For Class A devices, the process is relatively straightforward. For Class B devices, a more detailed review of technical documentation is expected. For Class C & D devices, strictest review of technical documentation is followed. Timelines typically range from 3 to 9 months depending on the Risk Classification of the device and completeness of the application.

MD-5: License to Manufacture for Sale or Distribution of Class A and B Medical Devices

License Issuance?

Companies who applied to manufacture Class A (low risk) and Class B (low-moderate risk) devices through Form MD-3 directly to the CDSCO MD Portal, obtains the permission to Manufacture Class A and B devices through MD-5.

Scope and Nature of MD-5 Licence

The MD-5 licence serves as the License to Manufacture for Sale or for Distribution of Class A and B Medical devices in India. Unlike the application stage (Form MD-3), this form represents the final regulatory authorization from CDSCO confirming that the manufacturer has met all applicable requirements under the Medical Devices Rules, 2017 and is approved to Manufacture Class A and B Medical Devices for Sale or Distribution.

Note: For manufacturing of Class A devices, CDSCO doesn’t conduct Audit of the Manufacturing site whereas for Class B devices, CDSCO conducts Audit of the Manufacturing site after providing Approval of License to Manufacture Class A and B devices in Form MD-5.

MD-7: Application for the grant of license to manufacture Class C and D Medical Devices

Who Applies?

Any company intending to manufacture Class C (moderate to high risk) and Class D (highest risk) Medical Devices in India must apply for a manufacturing license through Form MD-7 and submit the application to the CDSCO MD Portal.

Key Requirements for MD-7

• Completed Form MD-7.
• General information about the facility, Plant Layout of premise with indication of scale, Premises and facilities, Organisation chart showing the arrangements for key personnel,                                                                                    Qualification, Experience and responsibilities of key technical personnel, List of Equipment and Instruments used for manufacturing and testing, Sanitation, Production, Quality Assurance, Storage, Documentation, etc.
• Quality Management System (ISO 13485) as per Fifth Schedule of Medical devices Rules, 2017.
• Device Master File containing information such as Descriptive information, Labelling Details, Device Design and Manufacturing Information, Risk analysis and control summary, Design verification and validation, Biocompatibility validation data, Medicinal substances data (if device contains Drug), Biological Safety and Biocompatibility Validation Data, Sterilization Validation data, Software verification and validation (if software used) if any, Animal studies, Stability study data ((Real-time and Accelerated conditions), Clinical evidence, etc.
• Performance Evaluation Report of IVDs only
• Post Market Surveillance Data for the latest 5 years. 

MD-9: License to Manufacture for Sale or for Distribution of Class C and Class D Medical Devices 

License Issuance?

Companies who applied to manufacture Class C (moderate to high risk) and Class D (highest risk) devices through Form MD-7 directly to the CDSCO MD Portal, obtains the permission to Manufacture Class C and D devices through MD-9.

Scope and Nature of MD-9 Licence

The MD-9 licence serves as the License to Manufacture for Sale or for Distribution of Class C and D Medical devices in India. Unlike the application stage (Form MD-7), this form represents the final regulatory authorization from CDSCO confirming that the manufacturer has met all applicable requirements under the Medical Devices Rules, 2017 and is approved to Manufacture Class C and D Medical Devices for Sale or Distribution.

Note: For manufacturing of Class C and D devices, it is a mandatory requirement of the CDSCO to conduct Audit of the Manufacturing site before providing Approval of License to Manufacture Class C and D devices through Form MD-9.

Conclusion

The Manufacturing License forms for Sale or Distribution of Medical Devices under MDR 2017 — MD-3, MD-5, MD-7, and MD-9 — represent a well-structured framework that balances regulatory oversight with practicality. Choosing the correct form, preparing a complete dossier, and ensuring site readiness before inspection are the three most important factors in achieving a timely approval.

Ready to get started? Discuss your manufacturing license route with CliniExperts. Visit cliniexperts.com/india-regulatory-services/medical-device-for-manufacturer/ or email contact@cliniexperts.com