MD-7 AND MD-9 LICENSE REGISTRATION
[ Table Of Content ]
Introduction
The MD-7 and MD-9 Licenses are formal manufacturing licences issued under the Medical Devices Rules, 2017 to businesses involved in the production of medical devices in India. The MD-7 licence is granted for manufacturing Class C and Class D medical devices, which are categorized as low to moderate risk, while the MD-9 licence applies to Class C and Class D devices that fall under moderate to high-risk categories.
These licences are issued after the applicant submits the prescribed application and demonstrates compliance with quality management systems, infrastructure requirements, and technical standards. They ensure that manufacturers maintain consistent product quality, safety, and regulatory compliance. Without valid MD-7 or MD-9 licences, manufacturing of notified medical devices is not permitted in India. Proper documentation and adherence to guidelines help ensure smooth approval and continued compliance.
What is Form MD 7 and MD 9
Form MD-7 and Form MD-9 are key regulatory forms under the Medical Devices Rules, 2017, issued to manufacturers of medical devices in India. These forms are part of the licensing process that ensures devices are manufactured in compliance with prescribed safety, quality, and performance standards.
Form MD-7: Manufacturing License for Class A & B
Form MD-7 is the manufacturing license granted to businesses producing Class A and Class B medical devices, which are categorized as low to moderate risk. It is issued after the successful review of the application and verification of the manufacturing facility, quality systems, and technical documentation.
- Manufacturing license for Class A and Class B medical devices
- Issued by the State Licensing Authority
- Granted after approval of the prescribed application form
- Requires compliance with quality management systems and infrastructure standards
- Allows legal manufacturing and distribution of approved devices
Form MD-9: Manufacturing License for Class C & D
On the other hand, Form MD-9 is the manufacturing license issued for Class C and Class D medical devices, which fall under moderate to high-risk categories. Due to the higher risk involved, the approval process is more stringent and is handled by the Central Licensing Authority.
- Manufacturing license for Class C and Class D medical devices
- Issued by the Central Licensing Authority
- Granted after detailed technical evaluation and regulatory review
- Requires strict compliance with quality, safety, and performance standards
- Permits legal manufacturing and sale of high-risk medical devices
Together, Form MD-7 and Form MD-9 ensure that medical devices manufactured in India meet regulatory requirements, maintain high quality standards, and safeguard public health.
Registration Process for MD-7 & MD-9
Medical Device Manufacturing License is a mandatory requirement for businesses involved in the production of medical devices in India. Form MD-7 and Form MD-9 are issued under the Medical Devices Rules, 2017 and ensure that manufacturers comply with strict quality, safety, and performance standards throughout the production process.
If you are planning to obtain a manufacturing license for medical devices, following a structured and well-prepared process can help you avoid delays and regulatory issues. Below is the process explained in a simple and practical way.
Step 1: Application Submission Through CDSCO Portal
The process begins with submitting the application through the CDSCO online portal (SUGAM) or the respective licensing authority portal. At this stage, the applicant needs to:
- Fill out the prescribed application form MD-7
- Provide complete details of the manufacturing unit and device category
- Upload all required documents, including technical files and quality certifications
- Ensure the manufacturing facility complies with infrastructure and regulatory standards
Step 2: Payment of Government Fee
After completing the application, the applicant must pay the prescribed government fee based on the class of medical devices.
- Manufacturing site registration fee: 50,000/-
- Per Product registration fee: 1,000/-
- Payment is usually made online via net banking or other digital modes
- Fee is non-refundable
- Keep the payment acknowledgment safely, as it will be required during further processing
Step 3: Technical Review and Premises Inspection
Once the application is submitted, the licensing authority conducts a detailed review of the documents. For higher-risk devices, a thorough technical evaluation is carried out. This may include:
- Assessment of quality management system (ISO 13485 compliance)
- Review of device master file and technical documentation
- Inspection of manufacturing premises by designated officials
- Verification of equipment, testing facilities, and qualified staff
For MD-9 (Class C & D), the scrutiny is more rigorous due to the higher risk involved.
Step 4: Grant of Manufacturing License (MD-7 or MD-9)
If the application, documentation, and inspection are found satisfactory, the respective authority grants the manufacturing license. After receiving the license, the applicant is legally authorized to:
- Manufacture approved medical devices
- Sell and distribute products in the Indian market
- Operate in compliance with regulatory standards
Typical Timeline: 60–90 days (may vary depending on device class, authority, and completeness of the application).
Essential Documents for MD-7 & MD-9
Preparing documents in advance is critical for ensuring a smooth and timely approval process. Below is a comprehensive checklist of documents required for Form MD-7 (Application) and Form MD-9 (License Grant).
Business Documentation
Basic legal identification and proof of business registration required to establish the identity of the manufacturing entity.
- Duly filled Form MD-7
- Cover letter stating manufacturing intent and scope of Class C & D devices
- Certificate of Incorporation / Partnership Deed / Proprietorship proof
- GST Registration Certificate & PAN Card copy
- Details of Directors/Partners/Proprietor & Office address proof
- PAN Card copy of the company/firm
- Proof of registered office address
Premises & Manufacturing Facility
Detailed documentation regarding the physical location where the medical devices will be produced, ensuring the environment meets industrial standards.
- Layout plan of the manufacturing unit (with proper dimensions and sections)
- Site Master File (SMF)
- Ownership proof / Rent agreement / Lease deed of premises
- Photographs of manufacturing facility (interior & exterior)
- Details of plant & machinery installed Utility system details (HVAC, water system, cleanroom, etc.)
- Environmental control and contamination prevention measures
- Safety compliance and waste disposal mechanism
Device-Specific Documentation
Technical files that provide deep insights into the design, safety, and performance of each specific medical device.
- Device Master File (DMF) for each Class C & D device
- List of medical devices to be manufactured
- Product specifications and intended use
- Risk classification (Class C / Class D)
- Labels, IFU (Instructions for Use), and packaging details
- Design and engineering details of the device
- Clinical evaluation data (if applicable)
- Performance testing and validation reports
Personnel Documentation
Verification of the qualifications and experience of the technical staff responsible for manufacturing and quality testing.
- Qualification and Experience certificates of technical staff
- Experience certificates of key personnel
- Appointment letter of competent technical person
- Details of manufacturing head and quality assurance head
- Declaration of responsible technical personnel
Quality & Compliance
Evidence of a robust Quality Management System (QMS) to ensure consistent production and safety monitoring.
- ISO 13485 Certificate (mandatory for Class C & D)
- Quality Manual & Standard Operating Procedures (SOPs)
- Standard Operating Procedures (SOPs)
- GMP compliance & Risk management file (ISO 14971)
- Risk management file (as per ISO 14971)
- Equipment calibration & Process validation records
- Process validation and quality assurance procedures
- Internal audit reports and CAPA
Regulatory & Undertaking
Legal declarations and affidavits confirming the authenticity of information and commitment to regulatory rules.
- Declaration of compliance with Medical Devices Rules, 2017
- Undertaking for quality, safety, and traceability
- Affidavit confirming accuracy of information
- Copy of previous licenses & Power of Attorney (if applicable)
- Power of Attorney / Authorization letter (if application is filed by a consultant)
Ensuring that all these documents are accurate and up-to-date is the most critical step in securing your MD-7 or MD-9 manufacturing license without unnecessary delays.
Benefits of MD-7 & MD-9 License Registration
Obtaining an MD-7 (Manufacturing License for Class C & D Medical Devices) and MD-9 (Manufacturing License for Class C & D Medical Devices) offers comprehensive advantages for medical device manufacturers:
MD-7 and MD-9 License Approval Timeline, Validity, and Renewal
Obtaining an MD-7 or MD-9 License involves regulatory approval from the Central Drugs Standard Control Organization (CDSCO). These licenses are essential for manufacturers involved in the manufacture of medical devices in India.
- MD-7 is the application form used for obtaining a manufacturing license for Class C and Class D medical devices (higher-risk categories).
- MD-9 is the final manufacturing license granted after successful evaluation and approval of the MD-7 application.
The approval timeline depends largely on the risk classification of the device and the accuracy and completeness of the submitted application.
Approval Timeline for MD-7 and MD-9 License
In most cases, the expected approval timeline is as follows:
- Class C Devices: 60–90 days
- Class D Devices: 90–120 days
Since these are high-risk medical devices, the review process is more rigorous and includes detailed technical evaluation, clinical data assessment, and mandatory inspections.
The actual approval time may vary depending on several practical factors, such as:
- Completeness and accuracy of the application
- Quality of technical documentation and clinical evidence
- Queries or clarifications raised by CDSCO
- Timely response to regulatory questions
- Requirement for audits or site inspections
- Overall workload at CDSCO
Submitting a well-prepared application with comprehensive documentation can significantly reduce delays and improve approval chances.
Validity of MD-7 and MD-9 License
Once approved, the MD-9 License allows the manufacturer to legally manufacture and market Class C and Class D medical devices in India.
The license remains valid for 5 years, subject to continuous compliance with regulatory requirements and quality standards.
Manufacturers must strictly follow the provisions of the Medical Devices Rules, 2017 to maintain license validity.
Renewal / Retention Process of MD-7 and MD-9 License
Although the MD-9 license is granted for a defined validity period, manufacturers must follow a retention process to keep it active. The process generally involves:
Retention Fees
Payment of retention fees every 5 years to keep the license active.
Document Submission
Submission of updated compliance and quality-related documents.
Record Maintenance
Maintaining records of manufacturing, testing, and distribution.
Adverse Reporting
Reporting adverse events or product-related issues to the authority.
Manufacturers are also required to inform CDSCO about any major changes in:
- Device design
- Manufacturing process
- Plant location
- Ownership or constitution of the company
Failure to comply with these requirements may lead to suspension or cancellation of the license. After successful compliance and fee submission, the license remains valid, ensuring uninterrupted manufacturing and sale of medical devices in India.
Conclusion
MD-7 and MD-9 licenses play a critical role in regulating the manufacturing of Class C and Class D medical devices in India under the Medical Devices Rules, 2017. These licenses not only ensure strict compliance with quality, safety, and performance standards but also establish a strong regulatory framework for manufacturers dealing with higher-risk devices. From application and documentation to inspection and final approval, each step is designed to maintain product reliability and protect public health.
Obtaining these licenses enhances business credibility, enables smooth market access, and supports long-term growth. By maintaining proper compliance and timely renewal, manufacturers can ensure uninterrupted operations and contribute to a safer and more reliable healthcare ecosystem.