CDSCO License for Full-body MRI system, resistive magnet

Comprehensive Guide to CDSCO Licensing for Full-Body MRI Systems (Resistive Magnet)

As regulatory consultants with over 25 years of experience and having successfully guided more than 500 companies, we understand the complexities involved in obtaining CDSCO licenses for advanced medical devices like your Full-body MRI system with resistive magnet assembly. This guide provides detailed insights into the regulatory framework, timelines, costs, and documentation specifically tailored for Class C devices in the Interventional Radiology category.

Understanding Your Device and Regulatory Importance

A Full-body MRI system is a sophisticated diagnostic tool designed for detailed imaging of any targeted body region, utilizing a resistive magnet assembly. Given its critical role in diagnosis and patient safety, regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) ensures that only compliant and safe devices enter the Indian market. Your device falls under Class C, indicating a moderate to high risk requiring stringent evaluation.

CDSCO Regulatory Framework for Full-Body MRI Systems

CDSCO governs medical device registration through a structured risk-based classification system. For your Class C MRI system, the application for manufacturing license is processed centrally under the MD9 license scheme, while import licenses are granted via MD15. The process is rigorous, involving product testing, documentation, audits, and compliance with essential principles.

Risk Classification and License Requirements

Your Full-body MRI system is classified as Class C under the CDSCO medical device classification. According to the notification 29/Misc./03/2020-DC (146) dated 26.07.2021, this device falls in the Interventional Radiology category requiring:

• Manufacturing License: MD9 License (Form MD7)
• Import License: MD15 License (Form MD14)

The MD9 license is granted by the Central Licensing Authority, reflecting the device's moderate to high risk.

Manufacturing License Process (MD9)

The MD9 license process for Class C devices like your MRI system involves several critical steps:

1. Test License (Form MD13): Initially, obtain a test license, which takes approximately 1.5 to 2 months. This allows you to produce a limited quantity for testing.
2. Product Testing: Get your MRI system tested at government-approved laboratories. Testing is mandatory to demonstrate compliance with the essential principles of safety and performance. You can refer to the list of testing laboratories approved by CDSCO.
3. Document Preparation: Assemble a comprehensive dossier including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, QMS documents, and more.
4. Application Submission: Submit your application using Form MD7 on the CDSCO MD Online Portal.
5. Audit and Inspection: CDSCO officials will conduct an on-site audit of your manufacturing facility and quality management system.
6. Query Resolution: Address any queries raised by the department or audit team promptly.
7. License Grant: Upon successful completion, the MD9 manufacturing license is granted.

For a detailed understanding, our MD9 License Guide offers comprehensive insights.

Manufacturing License Documents Required

The documentation for your Full-body MRI system's MD9 license must be meticulously prepared. Key documents include:

• Company Constitution (e.g., incorporation certificate)
• Proof of ownership or lease agreement of manufacturing premises
• Details and qualifications of technical staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design, components, and specifications (DMF Guide)
• Plant Master File describing manufacturing processes and quality systems (Plant Master File Guide)
• Essential Principles Compliance Checklist
• Risk Management File demonstrating hazard identification and mitigation (Risk Management)
• Test reports from CDSCO-approved laboratories
• Labels and Instructions for Use (IFU) in English and local languages
• Quality Management System (QMS) documents aligned with ISO 13485:2016

Accuracy and completeness in documentation can significantly reduce processing time.

Import License Process (MD15)

If you plan to import the Full-body MRI system into India, the MD15 license is mandatory. The process includes:

1. Document Compilation: Prepare necessary documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, and your Indian company’s constitution.
2. Application Submission: Submit Form MD14 (for MD15 license) via the CDSCO MD Online Portal.
3. Evaluation and Queries: CDSCO reviews the application and may raise queries.
4. License Issuance: Upon satisfactory assessment, the import license is granted.

Note that no test license is required for imports. The entire import license process typically spans 5-6 months.

Refer to our Import License Guide for detailed procedural help.

Import License Documents Required

For a smooth import license application, prepare these documents:

• Valid manufacturing license of the device from the country of origin
• Free Sale Certificate demonstrating the product's marketing status abroad
• ISO 13485:2016 certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale drug license in India
• Company Constitution documents

Complete and accurate documentation expedites approval.

Timeline and Processing Duration

Plan your project timelines accordingly. Early preparation of documents and proactive response to queries can shorten these durations.

Government Fees and Costs

• Class C & D: ₹3,000 per site + ₹1,500 per product

Note: Fees are payable via the CDSCO MD Online Portal during application submission.

Common Challenges and Solutions

• Challenge: Delays due to incomplete documentation.

  • Solution: Use comprehensive checklists and expert reviews before submission.

• Challenge: Difficulty in coordinating government-approved testing.

  • Solution: Engage with notified testing laboratories early and schedule tests well in advance.

• Challenge: Audit non-conformities related to QMS or premises.

  • Solution: Conduct internal pre-audit assessments and remedial actions.

• Challenge: Query resolution delays.

  • Solution: Assign dedicated regulatory personnel to monitor and respond swiftly.

Expert Consultation and Support

Our team has helped over 500 medical device companies navigate CDSCO licensing successfully. We offer:

• Tailored gap analysis and compliance strategy
• Document preparation and review
• Liaison with notified bodies and testing labs
• Audit readiness training
• End-to-end application submission and follow-up

Partnering with experienced consultants mitigates risks and accelerates market entry.

Getting Started with Your CDSCO License Application

1. Assess Classification: Confirm your Full-body MRI system is Class C and requires MD9 and MD15 licenses.
2. Initiate Test License: Apply for the MD13 test license promptly to begin product testing.
3. Engage Laboratories: Contact CDSCO-approved laboratories early to schedule product testing.
4. Prepare Documentation: Begin compiling Device Master File, Plant Master File, Risk Management File, and QMS documents.
5. Plan Audits: Coordinate with CDSCO inspectors and notified bodies for upcoming audits.
6. Submit Applications: Use the CDSCO MD Online Portal for all submissions.
7. Monitor Progress: Track application status and respond to queries without delay.

Embarking on this journey with a structured plan and expert support ensures your Full-body MRI system meets all regulatory mandates, thus gaining timely access to the Indian market.

For personalized assistance, please contact us to leverage our extensive experience in CDSCO medical device licensing.