CDSCO License for X-ray/CT combined linear accelerator system
Medical Device Information
Intended Use
A combined system of a linear accelerator system and an X-ray CT system for radiotherapy planning.
Comprehensive Guide to CDSCO Licensing for X-ray/CT Combined Linear Accelerator System (Class C Medical Device)
As a trusted regulatory consultant with over 25 years of experience and a track record of assisting 500+ companies in successfully navigating the Indian medical device regulatory landscape, we understand the complexities involved in obtaining a CDSCO license for Class C devices like the X-ray/CT combined linear accelerator system. This device, a sophisticated radiotherapy tool integrating a linear accelerator and X-ray CT for precise cancer treatment planning, falls under a higher risk category demanding rigorous regulatory compliance.
CDSCO Regulatory Framework for X-ray/CT Combined Linear Accelerator System
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Devices Rules (MDR) 2017, with devices classified into four risk categories: Class A (low risk), B (low-moderate risk), C (moderate-high risk), and D (high risk). The X-ray/CT combined linear accelerator system is classified as Class C, reflecting its significant clinical risk and complexity.
For Class C devices, the CDSCO issues the MD9 manufacturing license, governed centrally, requiring thorough documentation, testing, and audit processes to ensure safety and efficacy.
Risk Classification and License Requirements for Class C Devices
Class C devices like the X-ray/CT combined linear accelerator system require:
- Manufacturing License (MD9) granted by the Central Licensing Authority
- Compliance with all safety, quality, and performance standards
- Test license (MD13) prior to full manufacturing license
- Product testing at CDSCO-approved laboratories
- Audit by CDSCO inspectors
You can review detailed classification criteria on our Medical Device Classification guide.
Manufacturing License Process (MD9) for X-ray/CT Combined Linear Accelerator System
The end-to-end process for an MD9 license typically takes about 4-5 months and involves these key steps:
- Apply for a Test License (Form MD13): This initial license allows limited manufacturing for the purpose of product testing. Processing time is approximately 1.5-2 months.
- Product Testing: Conduct mandatory testing at CDSCO-recognized testing laboratories to validate device safety and performance. Testing duration depends on the lab’s workload but expect 4-6 weeks. Refer to the Testing Laboratories list.
- Document Preparation: Assemble comprehensive technical documentation including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) records.
- Submit MD9 Application (Form MD7): File your manufacturing license application via the CDSCO MD Online Portal, attaching all required documents.
- CDSCO Audit: Inspectors will conduct a detailed onsite audit covering manufacturing facilities, QMS compliance, and technical documentation.
- Resolve Queries: Address any clarifications or deficiencies raised during audit or technical review.
- Grant of License (Form MD9): Upon satisfactory compliance, CDSCO issues the MD9 license, authorizing manufacturing.
Manufacturing License Documents Required for MD9
For a Class C device like the X-ray/CT combined linear accelerator system, prepare the following documentation meticulously:
- Company Constitution and Incorporation Certificates
- Proof of Ownership or Lease of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire and Pollution NOCs
- Device Master File (DMF): Detailed device description, design, manufacturing process, and specifications. Our Device Master File guide offers practical tips.
- Plant Master File (PMF): Manufacturing site details, infrastructure, equipment, and quality controls. See our Plant Master File guide.
- Essential Principles Compliance Checklist
- Risk Management File: Evidence of implementation aligned with ISO 14971. Learn more in our Risk Management resource.
- Test Reports from CDSCO-approved Labs
- Labels, Instructions for Use (IFU), and Packaging Details
- Quality Management System Documentation (ISO 13485:2016 certification is highly recommended)
Import License Process (MD15) for Class C Devices
If you are an importer intending to bring the X-ray/CT combined linear accelerator system into India, the import license process is handled by the Central Licensing Authority and usually takes 5-6 months. Unlike manufacturing, no test license is required.
Key steps include:
- Document preparation including valid manufacturing license, Free Sale Certificate, ISO 13485:2016, CE Certificate (if applicable), DMF, PMF, wholesale license, and company constitution.
- Application submission on the CDSCO MD Online Portal.
- Resolution of any queries by CDSCO.
- License grant on Form MD15.
Government fees vary by risk class; for Class C devices, expect:
- $3000 per site
- $1500 per product
Refer to our detailed Import License guide for more.
Timeline and Processing Duration
| Process Step | Timeframe |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 4 - 6 weeks |
| Document Preparation | Concurrent/Varies |
| MD9 Application Review | 1 - 1.5 months |
| Audit and Query Handling | 1 - 1.5 months |
| Total (Manufacturing) | 4 - 5 months |
| Import License (MD15) | 5 - 6 months |
Government Fees and Costs
For the MD9 manufacturing license (Class C devices):
- Application fee: Rs 50,000 per application
- Product fee: Rs 1,000 per product
Additional costs include product testing fees at approved laboratories (variable depending on device complexity) and audit expenses.
Common Challenges and Solutions
Incomplete Documentation: Missing or inconsistent technical files cause significant delays. We recommend early preparation of DMF, PMF, and Risk Management files with expert review.
Testing Delays: Limited slots and complex testing protocols can extend timelines. Scheduling tests well in advance with CDSCO-approved labs mitigates delays.
Audit Non-Compliance: Facility or QMS gaps can result in audit failures. Conduct internal pre-audits and staff training to ensure readiness.
Query Resolution: Slow responses to CDSCO queries prolong licensing. Assign dedicated regulatory personnel to manage communications promptly.
Expert Consultation and Support
Navigating the CDSCO licensing process for Class C devices such as the X-ray/CT combined linear accelerator system requires specialized knowledge and experience. Our team has successfully supported over 500 companies in securing timely approvals by:
- Conducting gap assessments of documentation and quality systems
- Assisting with preparation of Device and Plant Master Files
- Coordinating with notified bodies and testing labs
- Providing strategic guidance on audit readiness
- Managing end-to-end submission and follow-up on the CDSCO MD Online Portal
Getting Started with Your CDSCO License Application
- Verify Device Classification: Confirm your device is Class C per CDSCO guidelines.
- Initiate Test License Application (MD13): Prepare and submit your test license application to begin product testing.
- Engage CDSCO-Approved Testing Laboratory: Schedule testing early to avoid bottlenecks.
- Prepare Comprehensive Documentation: Start compiling DMF, PMF, Risk Management, and other required files.
- Plan for Audit: Ensure your manufacturing site and QMS meet CDSCO expectations.
- Submit MD9 Application (MD7): Once testing is successful and documents are ready, apply via the online portal.
- Communicate Promptly: Respond to audit and regulatory queries without delay.
Our expert consulting services are available to guide you through each step, minimizing risks and expediting approvals for your X-ray/CT combined linear accelerator system. Contact us today to leverage our proven expertise in CDSCO licensing for advanced radiotherapy medical devices.
For detailed insights, visit our dedicated MD9 License Guide.
