Manufacturing License MD-7 & MD-9

Introduction to Manufacturing License MD-7 & MD-9

The MD-7 and MD-9 Licences are official manufacturing approvals issued under the Medical Devices Rules, 2017 for companies engaged in manufacturing medical devices in India. The MD-7 licence is issued for the manufacturing of Class A and Class B medical devices, which are considered low to low-moderate risk products. In contrast, the MD-9 licence is required for Class C and Class D medical devices, which fall under moderate to high-risk categories.

These licences are granted after the applicant submits the prescribed application and fulfills the required regulatory conditions, including compliance with quality management systems, infrastructure standards, and technical specifications. The purpose of these licences is to ensure that medical device manufacturers maintain product safety, quality, and regulatory compliance throughout the manufacturing process. Manufacturing notified medical devices in India without a valid MD-7 or MD-9 licence is not permitted.

What are Form MD-7 and Form MD-9?

Form MD-7 and Form MD-9 are important manufacturing licenses issued under the Medical Devices Rules, 2017 for medical device manufacturers in India. These licenses confirm that the manufacturer complies with the required quality, safety, and performance standards for producing medical devices.

Registration Process for MD-7 & MD-9

Obtaining a Medical Device Manufacturing License is a mandatory requirement for companies manufacturing medical devices in India. Businesses planning to manufacture medical devices should follow a systematic registration process to avoid delays, compliance issues, or rejection of the application.

1. 1
   Submission of Application on the CDSCO PortalThe registration process begins with filing the application through the CDSCO SUGAM portal or the concerned licensing authority portal. Complete the prescribed application form accurately, provide details of the manufacturing facility and medical device category, and upload all necessary documents.
2. 2
   Payment of Government FeesAfter submitting the application, pay the applicable government fees based on the class and number of medical devices. For MD-9 (Class C & D): Site registration fee of ₹50,000 and ₹1,000 per product. Payment is made online through digital payment methods and the fee paid is non-refundable.
3. 3
   Technical Evaluation and Factory InspectionThe licensing authority reviews submitted documents and technical information. This includes evaluation of the Quality Management System (ISO 13485 compliance), examination of Device Master File, inspection of the manufacturing facility, and verification of machinery, testing equipment, and qualified technical personnel.
4. 4
   Query Resolution and ClarificationsIf CDSCO raises any queries or requests additional information, the applicant must submit proper responses, revised documents, and clarifications within the stipulated time period to avoid delays in the approval process.
5. 5
   Grant of MD-7 or MD-9 LicenseIf the licensing authority is satisfied with the application, technical review, and inspection findings, the manufacturing license is granted. The manufacturer is then legally permitted to manufacture approved medical devices and sell and distribute products in the Indian market.

Government Fees for MD-7 & MD-9 License

The fee structure for MD-7 and MD-9 manufacturing licenses depends on the device class and number of products included in the application.

Manufacturing License Fees — Class A & B Devices (MD-7)

Manufacturing License Fees — Class C & D Devices (MD-9)

Essential Documents Required for MD-7 & MD-9

Preparing the required documents in advance plays a major role in avoiding delays during the approval process. Below is a detailed list of documents generally required for Form MD-7 and MD-9 applications.

Business & Legal Documents

• Completed Form MD-7 Application
• Certificate of Incorporation / Partnership Deed
• GST Registration Certificate & PAN Card
• Details of Directors / Partners / Proprietor
• Registered Office Address Proof
• Company PAN Card Copy

Premises & Manufacturing Facility Documents

• Layout Plan of Manufacturing Facility
• Site Master File (SMF)
• Ownership Proof / Lease Deed / Rent Agreement
• Interior & Exterior Photographs
• Details of Installed Plant & Machinery
• HVAC, Water Systems & Cleanroom Details
• Environmental Monitoring & Contamination Control
• Safety Systems & Waste Disposal Arrangements

Device-Specific Technical Documents

• Device Master File (DMF) for Each Device
• List of Medical Devices for Manufacturing
• Product Specifications & Intended Purpose
• Device Risk Classification Details
• Product Labels, Packaging & IFU
• Design & Engineering Specifications
• Clinical Evaluation Reports (if applicable)
• Performance Testing & Validation Reports

Personnel & Quality Documents

• Educational Qualification of Technical Staff
• Experience Certificates of Key Employees
• ISO 13485 Certificate (Mandatory for Class C & D)
• Quality Manual & Standard Operating Procedures
• GMP Compliance Documents
• Risk Management File (ISO 14971)
• Equipment Calibration Records
• Internal Audit Reports & CAPA Documentation

Regulatory Declarations & Undertakings

• Declaration of Compliance with MDR 2017
• Undertaking on Product Quality & Safety
• Affidavit Confirming Information Accuracy
• Copies of Previous Licenses (if available)
• Power of Attorney (if through a consultant)
• Cover Letter for Manufacturing Activities Scope

Approval Timeline for MD-7 & MD-9 License

The overall approval process generally takes around 60 to 90 days. However, the timeline may vary depending on the device category, completeness of documents, and observations raised by the licensing authority.

• Class A & B Devices (MD-7): ~1–2 months
• Class C Devices (MD-9): ~60–90 days
• Class D Devices (MD-9): ~90–120 days
• With Pending Queries: May extend further

Submitting properly prepared documents and maintaining regulatory compliance can help significantly reduce delays during the approval process.

Validity & Renewal of MD-7 and MD-9 License

After approval, the MD-9 License authorizes manufacturers to legally manufacture and market approved Class C and Class D medical devices in India. The license is generally valid for five years, provided the manufacturer continues to comply with all applicable regulatory and quality requirements under the Medical Devices Rules, 2017.

To keep the manufacturing license active, manufacturers are required to follow the prescribed retention and compliance procedures, including:

• Retention Fee Payment Every 5 Years
• Updated Compliance Documents Submission
• Proper Record Maintenance (Manufacturing & Testing)
• Adverse Event Reporting to CDSCO
• Notify Changes in Device Specifications
• Notify Changes in Factory Location
• Notify Changes in Company Ownership
• Notify Changes in Manufacturing Process

Benefits of MD-7 & MD-9 License Registration

Obtaining an MD-7 and MD-9 Manufacturing License provides several important benefits to medical device manufacturers operating in India. These licenses not only ensure regulatory compliance but also help businesses strengthen market presence and maintain product quality standards.

Why Hire a Professional Consultant for MD-7 & MD-9?

An experienced regulatory consultant helps businesses correctly prepare technical documentation, manage the entire application process, and ensure compliance with the Medical Devices Rules, 2017.

Professional guidance helps reduce application errors, avoid unnecessary delays, minimize the chances of rejection, and assists in maintaining long-term regulatory compliance with CDSCO guidelines.

Conclusion

The MD-7 and MD-9 Licenses are essential regulatory approvals for companies involved in the manufacturing of medical devices in India. Issued under the Medical Devices Rules, 2017, these licenses ensure that manufacturers comply with the required safety, quality, and performance standards established by CDSCO. While MD-7 is associated with the manufacturing approval process for lower-risk medical devices, MD-9 is granted for moderate to high-risk devices after detailed technical evaluation and inspection.

Obtaining these licenses not only provides legal authorization to manufacture and market medical devices in India but also helps businesses strengthen product quality, regulatory compliance, and market credibility. Manufacturers who maintain continuous compliance, timely renewals, and proper quality control systems can operate efficiently while contributing to the delivery of safe and reliable medical devices in the Indian market.