CDSCO License for Full-body MRI system, superconductin g magnet

Comprehensive Guide to CDSCO Licensing for Full-Body MRI Systems with Superconducting Magnets (Class C)

As a diagnostic general-purpose magnetic resonance imaging system, a full-body MRI with a superconducting magnet is a complex, high-risk medical device classified as Class C under Indian regulations. Given its critical role in interventional radiology and patient diagnosis, securing the appropriate CDSCO license is crucial for legal manufacturing and import in India. With over 25 years of regulatory consulting experience and having assisted more than 500 companies, we provide a detailed roadmap for obtaining your CDSCO license efficiently and compliantly.

Understanding the CDSCO Regulatory Framework for Full-Body MRI Systems

The Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices in India. Since the notification 29/Misc./03/2020-DC (146) dated 26.07.2021, full-body MRI systems with superconducting magnets fall under Class C devices due to their potential risk and complexity.

Class C devices require stringent oversight by the Central Licensing Authority, involving comprehensive assessment protocols including product testing, quality system audits, and compliance with essential principles.

Risk Classification and License Requirements for Class C Devices

Medical devices in India are classified into four risk classes: A, B, C, and D. The full-body MRI system is Class C, indicating moderate to high risk, which necessitates obtaining an MD9 manufacturing license for domestic production or an MD15 import license for importers.

MD9 License: Mandatory for manufacturers of Class C devices, issued by the Central Licensing Authority.
MD15 License: Required for importers, also granted by the Central Licensing Authority.

Manufacturing License Process for Class C Full-Body MRI Systems (MD9 License)

The MD9 licensing process is comprehensive and involves several critical steps:

Test License Application (Form MD13): Before applying for MD9, manufacturers must obtain a test license to conduct product testing. This process typically takes 1.5 to 2 months.
Product Testing: Full-body MRI systems must be tested at CDSCO-approved laboratories to validate safety and performance. Refer to the list of Testing Laboratories for approved centers.
Document Preparation: Assemble all technical and quality documents including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, test reports, and Quality Management System (QMS) documentation.
License Application Submission (Form MD7): Submit the application through the CDSCO MD Online Portal.
Audit and Inspection: CDSCO inspectors will conduct a thorough audit of manufacturing facilities, QMS, and compliance documents.
Query Resolution: Address any queries raised by the CDSCO during the review or audit process.
License Grant (Form MD9): Upon successful completion, the MD9 manufacturing license is issued.

Manufacturing License Documents Required

For your full-body MRI system, ensure the following documents are prepared meticulously:

Company Constitution or Incorporation Certificate
Proof of ownership or lease of manufacturing premises
Details of technical staff with qualifications
Fire NOC and Pollution Control Board NOC
Device Master File detailing design, components, and specifications (Device Master File Guide)
Plant Master File describing manufacturing processes and infrastructure (Plant Master File Guide)
Essential Principles Checklist confirming compliance with Indian Medical Device Rules
Risk Management File highlighting hazard analysis and mitigation strategies (Risk Management)
Test Reports from CDSCO-approved labs
Product labels and Instructions for Use (IFU)
Quality Management System (QMS) documentation aligned with ISO 13485:2016

Import License Process for Full-Body MRI Systems (MD15 License)

If you intend to import the device into India, the MD15 license process applies:

Document Preparation: Collect necessary documents such as existing manufacturing license (MD9 or equivalent), Free Sale Certificate from the country of origin, ISO 13485:2016 certification, CE Certificate (if available), Device and Plant Master Files, wholesale license, and company registration.
Application Submission (Form MD14): File your import license application via the CDSCO MD Online Portal.
Review and Query Resolution: CDSCO reviews the application and may raise queries.
License Issuance (Form MD15): Upon satisfactory compliance, the import license is granted.

Import License Documents Required

Key documents for the MD15 application include:

Valid Manufacturing License (MD9 or equivalent from the country of origin)
Free Sale Certificate
ISO 13485:2016 Certificate
CE Certificate (if applicable)
Device Master File and Plant Master File
Wholesale License
Company Constitution and Registration Proof

Timeline and Processing Duration

MD9 Manufacturing License: Approximately 4 to 5 months total.
- Test License (MD13): 1.5 to 2 months
- Product Testing: 1 to 1.5 months
- Document Preparation & Audit: 1.5 to 2 months
MD15 Import License: Approximately 5 to 6 months from application submission.

Government Fees and Costs

MD9 License Fee: ₹50,000 per application plus ₹1,000 per product.
MD15 Import License Fee: For Class C devices, ₹3,000 per site and ₹1,500 per product.

These fees are payable online through the CDSCO portal during application submission.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

Solution: Engage early with CDSCO-approved testing labs listed here to schedule slots and confirm testing protocols.

Challenge 2: Incomplete or Non-Compliant Documentation

Solution: Utilize comprehensive guides such as our Device Master File Guide and Plant Master File Guide to prepare robust and compliant documentation.

Challenge 3: Audit Non-Conformities

Solution: Conduct internal audits and gap analyses before CDSCO inspections. Ensure your QMS is ISO 13485:2016 certified and fully implemented.

Challenge 4: Query Resolution Delays

Solution: Respond promptly with clear, detailed information. Maintaining open communication with the CDSCO helps expedite the process.

Expert Consultation and Support

Navigating the CDSCO licensing landscape for high-risk devices like full-body MRI systems can be challenging. Our team, with over two decades of experience, offers end-to-end support—from document preparation and submission to audit readiness and post-approval compliance.

We have successfully guided over 500 companies through the MD9 licensing process, ensuring timely approvals and market entry. Our expertise extends to liaising with CDSCO officials, coordinating with notified bodies, and managing regulatory submissions.

Getting Started with Your CDSCO License Application

Assess Your Device Classification: Confirm your device is Class C by reviewing the Medical Device Classification.
Prepare Essential Documentation: Initiate development of your Device Master File, Plant Master File, and Risk Management File using our detailed guides.
Apply for Test License (MD13): Submit the test license application via the CDSCO MD Online Portal.
Plan Product Testing: Coordinate with CDSCO-approved labs early to avoid delays.
Compile and Submit MD9 Application: Ensure all documents are complete and submit your manufacturing license application.
Prepare for Audit: Conduct internal reviews and prepare for the CDSCO inspection.
Engage with Experts: Consider consulting with regulatory specialists to streamline the process, mitigate risks, and handle complex queries.

By following these actionable steps and leveraging our extensive industry experience, manufacturers and importers of full-body MRI systems can confidently navigate the CDSCO licensing requirements and successfully enter the Indian medical device market.

For personalized assistance and to accelerate your licensing process, contact our expert regulatory team today.

CDSCO License for Full-body MRI system, superconductin g magnet

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