CDSCO License for Full-body MRI system, permanent magnet
Medical Device Information
Intended Use
A general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body. It includes a permanent magnet assembly.
Comprehensive Guide to CDSCO Licensing for Full-Body Permanent Magnet MRI Systems (Class C Medical Device)
In the evolving landscape of medical technology in India, securing the appropriate regulatory approvals is critical for manufacturers and importers aiming to market advanced devices such as a full-body MRI system with a permanent magnet. Classified as a Class C device under the CDSCO framework, this interventional radiology equipment demands rigorous compliance with India’s regulatory norms to ensure safety, efficacy, and market access.
With over 25 years of specialized experience and having assisted more than 500 companies in navigating the CDSCO licensing process, we present an authoritative, step-by-step guide tailored specifically for full-body MRI systems. Our expertise covers the entire spectrum of regulatory requirements — from license application to audit and approval.
CDSCO Regulatory Framework for Full-Body MRI Systems
India regulates medical devices under the Medical Device Rules (MDR) 2017, enforced by the Central Drugs Standard Control Organization (CDSCO). Full-body MRI systems fall under Class C devices, identified due to their medium to high risk profile given their complex technology and clinical use.
The CDSCO oversees the licensing process centrally for Class C devices, which includes both manufacturing and import licensing. This regulatory oversight ensures that stringent quality and safety standards are met before these sophisticated imaging devices enter the Indian healthcare market.
For a comprehensive understanding of device classification, manufacturers can refer to the Medical Device Classification overview.
Risk Classification and License Requirements for Full-Body MRI Systems
- Device Name: Full-body MRI system, permanent magnet
- Risk Class: Class C
- Intended Use: General-purpose MRI scanning for any body area
- Category: Interventional Radiology
- Notification Number: 29/Misc./03/2020-DC (146)
- Notification Date: 26.07.2021
Class C devices require a Manufacturing License (MD9) issued by the Central Licensing Authority and an Import License (MD15) for companies importing the device.
Manufacturing License Process (MD9) for Class C Devices
Obtaining an MD9 manufacturing license is a multi-step process involving documentation, product testing, audits, and regulatory review:
Test License (Form MD13): Begin by applying for a test license, allowing you to manufacture a limited quantity for testing. This step typically takes 1.5 to 2 months.
Product Testing: Conduct testing of the MRI system at government-approved laboratories to verify compliance with Indian standards. Refer to the list of approved testing laboratories.
Document Preparation: Prepare comprehensive documentation, including the Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.
License Application (Form MD7): Submit your manufacturing license application through the CDSCO MD Online Portal.
Audit: CDSCO inspectors conduct a thorough on-site audit of the manufacturing facility.
Queries Resolution: Address any queries raised by the regulator or inspectors promptly to avoid delays.
Grant of License (Form MD9): Upon successful audit and document review, the MD9 license is granted.
The entire process generally spans 4 to 5 months, contingent on timely submission and query responses.
For detailed insights, consult our MD9 License Guide.
Manufacturing License Documents Required for Full-Body MRI Systems
To ensure a smooth audit and approval process, manufacturers must compile the following key documents:
- Company Constitution and Incorporation Documents: Proof of legal entity
- Proof of Ownership or Lease of Manufacturing Premises
- Details of Technical Staff: Qualification and experience certificates
- Fire Safety NOC and Pollution Control NOC
- Device Master File (DMF): Detailed device specifications, design, and manufacturing processes. Our Device Master File guide provides an excellent resource.
- Plant Master File (PMF): Information about the manufacturing site and quality systems. Learn more with our Plant Master File guide.
- Essential Principles Checklist: Compliance with Indian medical device essential principles
- Risk Management File: Documentation of risk assessments and mitigation strategies. Refer to our Risk Management implementation guide.
- Test Reports: From government-approved testing laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System Documents: ISO 13485:2016 certification and related procedures
Ensuring completeness and accuracy at this stage reduces audit back-and-forth and expedites approval.
Import License Process (MD15) for Full-Body MRI Systems
Manufacturers or importers seeking to bring full-body MRI systems into India must obtain an MD15 Import License from CDSCO’s Central Licensing Authority.
Key steps include:
Document Preparation: Assemble all required documentation, including manufacturing license, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files.
Submission of Application (Form MD14): File the import license application using the CDSCO MD Online Portal.
Regulatory Review and Queries: Respond to any queries raised during document evaluation.
License Grant (Form MD15): Upon satisfactory review, CDSCO grants the import license.
The timeline for MD15 licensing typically ranges between 5 to 6 months.
Our comprehensive Import License Guide offers stepwise assistance.
Import License Documents Required for Full-Body MRI Systems
The import license application must be supported by the following documents:
- Valid Manufacturing License (MD9) from the country of origin
- Free Sale Certificate or Equivalent from Regulatory Authority of Exporting Country
- ISO 13485:2016 Certification
- CE Certificate or Equivalent Product Certification
- Device Master File and Plant Master File
- Wholesale License (if applicable)
- Company Constitution and Registration Documents
Accuracy and thoroughness in documentation significantly influence the approval speed.
Timeline and Processing Duration for Full-Body MRI System Licensing
| License Type | Approximate Duration | Remarks |
|---|---|---|
| Test License (MD13) | 1.5 - 2 months | Required before manufacturing test units |
| Manufacturing License (MD9) | 4 - 5 months | Includes audit and query resolution |
| Import License (MD15) | 5 - 6 months | No test license required |
Planning ahead and maintaining communication with CDSCO can help avoid unexpected delays.
Government Fees and Costs
| License Type | Fee Structure | Approximate Cost (INR) |
|---|---|---|
| MD9 Manufacturing License | Rs. 50,000 per application + Rs. 1,000 per product | Rs. 51,000+ (for one product) |
| MD15 Import License | Rs. 3,000 per site + Rs. 1,500 per product | Rs. 4,500+ (for one product) |
Note: Fees are subject to revision by CDSCO. Budgeting for additional costs such as testing, audits, and consultancy is recommended.
Common Challenges and Solutions
Incomplete Documentation: Missing or inconsistent documents cause delays. Solution: Use detailed checklists and expert reviews before submission.
Delays in Product Testing: Limited slots in government-approved labs can extend timelines. Solution: Book testing in advance and consider multiple approved labs.
Audit Non-compliance: Facility or process non-conformities detected during audit. Solution: Conduct mock audits and implement corrective actions prior.
Query Resolution Delays: Slow response to CDSCO queries stalls approvals. Solution: Assign dedicated regulatory personnel for prompt replies.
Understanding Regulatory Updates: Notifications such as 29/Misc./03/2020-DC (146) require close monitoring. Solution: Subscribe to CDSCO updates and consult regulatory experts.
Expert Consultation and Support
Navigating the CDSCO licensing pathway for high-risk devices like full-body MRI systems can be complex. Our seasoned consultancy leverages:
- In-depth understanding of CDSCO regulations and notifications
- End-to-end support from documentation to audit readiness
- Liaison with notified bodies and testing laboratories
- Customized risk management and quality system implementation
Partnering with experienced consultants drastically improves the success rate and expedites market entry.
Getting Started with Your CDSCO License Application
To initiate your CDSCO license for your full-body permanent magnet MRI system:
- Assess Device Classification: Confirm Class C status and regulatory implications.
- Prepare Test License Application: Apply for Form MD13 via the CDSCO MD Online Portal.
- Identify Approved Testing Laboratories: Schedule product testing early.
- Collect and Draft Documentation: Utilize our Device Master File and Plant Master File guides.
- Plan for Audit: Ensure compliance with QMS and regulatory requirements.
- Submit Manufacturing License Application (Form MD7): Begin formal process post-testing.
- Prepare Import License Application (Form MD14): For importers, after manufacturing license acquisition.
Engaging with regulatory experts at each stage enhances clarity and compliance, reducing time to market for your advanced MRI technology in India.
Ready to start? Visit the CDSCO MD Online Portal to submit your application or contact us for personalized assistance.
