CDSCO License for Normalizing Quantitative Electroencephalograph Software

Introduction to Normalizing Quantitative Electroencephalograph Software and Regulatory Importance

The Normalizing Quantitative Electroencephalograph (QEEG) Software is a sophisticated medical device software used for post-hoc statistical analysis of EEG signals. It compares patient data with a normative database to assist qualified clinical users in diagnosis and treatment planning. Given its direct impact on clinical decision-making, this Class C software falls under a higher risk category requiring stringent regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) in India.

Navigating the CDSCO licensing process is critical for manufacturers and importers aiming to legally market this device in India. With over 25 years of experience and having supported 500+ companies, we provide you a comprehensive roadmap tailored to this device’s unique regulatory pathway.

CDSCO Regulatory Framework for Normalizing Quantitative Electroencephalograph Software

Medical device software like the QEEG is regulated under CDSCO’s Medical Device Rules, 2017, classified as Class C due to its moderate to high risk profile. The regulatory pathway mandates strict compliance with standards including ISO 13485 and adherence to the Essential Principles of Safety and Performance.

The official notification governing this device is 29/Misc./03/2020-DC (198) dated 13.9.2021, which explicitly classifies it under software category and establishes the need for a central licensing authority approval via an MD9 manufacturing license.

Risk Classification and License Requirements for Class C Software

Class C devices, such as the Normalizing QEEG Software, present a higher risk to patients and require:

• A manufacturing license granted by the Central Licensing Authority (CDSCO)
• Compliance with clinical evaluation and performance testing
• A thorough audit by CDSCO inspectors

The license type applicable is the MD9 license (Form MD7 for application), which includes comprehensive documentation, testing, and audits.

You can check detailed medical device classification to confirm your device’s risk class.

Manufacturing License Process (MD9) for Normalizing QEEG Software

The MD9 license process for Class C devices involves several critical stages:

1. Test License Application (Form MD13) – Obtain a test license valid for 1.5-2 months.
2. Product Testing – Conduct mandatory testing at CDSCO recognized laboratories. Refer to the list of testing laboratories for accredited centers.
3. Document Preparation – Compile all required technical, quality, and regulatory documents.
4. Application Submission (Form MD7) – Submit the manufacturing license application on the CDSCO MD Online Portal.
5. CDSCO Audit – Undergo a comprehensive inspection by CDSCO auditors.
6. Query Resolution – Address any observations or queries raised during audits.
7. Grant of License (Form MD9) – Upon successful review and compliance, the MD9 manufacturing license is granted.

This process typically spans 4-5 months from start to finish.

Manufacturing License Documents Required for MD9

For Normalizing QEEG Software, the documentation must be meticulously prepared, including but not limited to:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF) detailing software architecture, algorithms, and validation. Our detailed Device Master File guide can assist you.
• Plant Master File describing manufacturing setup (Plant Master File Guide)
• Essential Principles Checklist conforming to CDSCO requirements
• Risk Management File documenting hazard analysis and mitigation strategies (Risk Management)
• Test Reports from CDSCO approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485:2016 certification

Attention to detail in these documents significantly reduces audit queries and accelerates approval.

Import License Process (MD15) for Normalizing QEEG Software

If you are an importer rather than a manufacturer, you must apply for the MD15 import license via Form MD14. The process includes:

• Comprehensive document preparation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485, CE Certificates, and related files.
• Submission on the CDSCO MD Online Portal.
• Resolution of any departmental queries.
• Grant of import license.

This process generally takes 5-6 months for Class C devices.

For detailed steps, refer to our dedicated Import License Guide.

Timeline and Processing Duration

Planning your regulatory submission while aligning with these timelines ensures a smooth approval process.

Government Fees and Costs for MD9 License

For Class C devices like the Normalizing QEEG Software, fees are as follows:

• Application Fee: ₹50,000
• Per Product Fee: ₹1,000

Additional costs include testing fees, notified body audit charges, and consultant fees if applicable. Early budgeting helps avoid surprises.

Common Challenges and Solutions

Challenge 1: Incomplete or inconsistent documentation

• Solution: Use checklists and expert consultation to ensure all documents meet CDSCO standards.

Challenge 2: Delays in product testing due to lab backlogs

• Solution: Plan testing early and choose labs from the official CDSCO testing laboratories list.

Challenge 3: Audit non-compliance issues

• Solution: Conduct internal mock audits and address gaps proactively.

Challenge 4: Misclassification of device risk leading to wrong license application

• Solution: Confirm classification via CDSCO and resources like the Medical Device Classification guide.

Expert Consultation and Support

With two and a half decades of experience, we have supported over 500 companies in successfully obtaining CDSCO licenses for complex software devices including QEEG software. Our end-to-end services include:

• Device classification and regulatory strategy
• Document preparation including DMF and PMF
• Liaison with CDSCO and notified bodies
• Audit readiness and QMS implementation
• Timely submission and follow-up

Partnering with experts significantly reduces the risk of delays and rejections.

Getting Started with Your CDSCO License Application for Normalizing QEEG Software

1. Verify Device Classification: Confirm your device is Class C as per notification 29/Misc./03/2020-DC (198).
2. Prepare Test License Application (MD13): Submit on the CDSCO MD Online Portal.
3. Schedule Product Testing: Book slots at CDSCO approved labs early.
4. Compile All Required Documents: Use our device and plant master file guides to prepare comprehensive dossiers.
5. Engage a Regulatory Consultant: To ensure audit readiness and smooth communication with CDSCO.
6. Submit MD9 License Application (Form MD7): Once test license and testing are complete.
7. Prepare for Audit: Conduct internal audits and address gaps promptly.

Starting early, maintaining clear documentation, and following these steps improves your chances of a timely license grant.

For more detailed guidance, explore our MD9 License Guide and reach out to our expert team for personalized assistance.