CDSCO License for X-ray/MR combined linear accelerator system.
Medical Device Information
Intended Use
A system intended to provide treatment planning, image- guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment in indicated. The system operates on the principle of linear acceleration of electrons, providing a predictable radiation field in a beam of well-defined dimensions
Understanding the X-ray/MR Combined Linear Accelerator System and Its Regulatory Importance
The X-ray/MR combined linear accelerator system is an advanced radiotherapy device designed to deliver precise, image-guided stereotactic radiosurgery and radiotherapy for tumors and lesions anywhere in the body. Operating on the principle of linear acceleration of electrons, it produces a highly controlled radiation beam essential for effective cancer treatment. Given its critical role and inherent risks associated with ionizing radiation, regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) in India is mandatory before manufacturing or importing this device.
Navigating the CDSCO licensing framework for such a high-risk Class C device requires detailed understanding of regulatory nuances, timelines, and precise documentation. With over 25 years of experience assisting 500+ companies, we provide you with expert insights and practical steps to efficiently secure your MD9 manufacturing or MD15 import license.
CDSCO Regulatory Framework for X-ray/MR Combined Linear Accelerator Systems
In India, medical devices are regulated under the Medical Device Rules (MDR) 2017, enforced by CDSCO. Devices are classified into risk classes A, B, C, and D, based on their potential risk to patients. The X-ray/MR combined linear accelerator system falls under Class C, which signifies a moderate to high risk, necessitating a central license.
Manufacturers of Class C devices must obtain the MD9 license from CDSCO's Central Licensing Authority, whereas importers require the MD15 import license. Both licenses involve rigorous documentation, testing, and audits to ensure safety and efficacy.
For detailed classification criteria, consult our Medical Device Classification guide.
Risk Classification and License Requirements for Class C Devices
- Risk Class: C
- License Type: MD9 (Manufacturing License) or MD15 (Import License)
- Regulatory Authority: Central Licensing Authority, CDSCO
- Key Compliance: Test license (MD13), product testing from government-approved laboratories, audit by CDSCO inspectors
This classification demands comprehensive documentation and adherence to quality management systems such as ISO 13485:2016.
Manufacturing License Process for X-ray/MR Combined Linear Accelerator (MD9 License)
The manufacturing license for Class C devices involves multiple steps:
- Apply for Test License (Form MD13): Enables initial product testing; processing time approximately 1.5 to 2 months.
- Product Testing: Conduct testing at CDSCO-approved labs; use the Testing Laboratories list to select.
- Document Preparation: Compile comprehensive documentation including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and QMS documents.
- Submission of Manufacturing License Application (Form MD7): Apply through the CDSCO MD Online Portal.
- CDSCO Inspection and Audit: CDSCO officials conduct an on-site audit to verify compliance.
- Query Resolution: Address any observations or deficiencies raised during audit.
- License Grant (Form MD9): Upon satisfactory review, the manufacturing license is granted.
Practical Tip:
Engage a notified body early for audit preparation. The Notified Bodies List will help you select a suitable organization.
Manufacturing License Documents Required for MD9
- Company Constitution (Certificate of Incorporation)
- Proof of ownership or lease agreement of the manufacturing premises
- Technical staff qualifications and experience certificates
- Fire and Pollution NOCs
- Device Master File (DMF): Detailed device specifications, design, manufacturing, and performance data. Refer to our Device Master File Guide
- Plant Master File (PMF): Facility details, infrastructure, and quality controls; see our Plant Master File Guide
- Essential Principles Compliance Checklist
- Risk Management File demonstrating hazard analysis, risk evaluation, and mitigation steps (Risk Management Guide)
- Test Reports from CDSCO-approved labs
- Labeling and Instructions for Use (IFU)
- Quality Management System documents, including ISO 13485:2016 certification
Import License Process for X-ray/MR Combined Linear Accelerator (MD15 License)
Importers must obtain the MD15 license from CDSCO’s Central Licensing Authority. The process includes:
- Prepare Import Dossier: Include all required documentation as per CDSCO guidelines.
- Submit Application on Form MD14: Apply via the CDSCO MD Online Portal.
- Query Resolution: Respond promptly to any department queries.
- License Grant (Form MD15): CDSCO issues the import license.
Unlike manufacturing, no test license is required for imports; however, comprehensive documentation and certifications are mandatory.
Import License Documents Required for MD15
- Valid Manufacturing License from the country of origin
- Free Sale Certificate from the exporting country
- ISO 13485:2016 Certification
- CE Certificate or equivalent regulatory approval
- Device Master File and Plant Master File
- Wholesale license (if applicable)
- Company Constitution
Timeline and Processing Duration
| License Type | Process Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| MD9 Manufacturing | 4 to 5 months (including MD13) |
| MD15 Import License | 5 to 6 months |
Manufacturers should anticipate a total timeline of approximately 4-5 months from test license application to MD9 grant, while importers should budget 5-6 months for MD15 licensing.
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD9 Manufacturing | ₹50,000 | ₹1,000 per product |
| MD15 Import | Class C: $3,000/site | $1,500 per product |
Additional costs include laboratory testing fees, audit fees (if applicable), and consultancy fees where expert support is engaged.
Common Challenges and Solutions
- Delay in Test Reports: Select CDSCO-approved labs with shorter turnaround times; maintain regular communication.
- Incomplete Documentation: Utilize comprehensive checklists and templates from experts to avoid back-and-forth.
- Audit Non-Compliance: Conduct internal audits and gap analyses before CDSCO inspection.
- Query Resolution Delays: Respond promptly and accurately to queries raised by CDSCO.
Our extensive experience enables us to anticipate these challenges and guide clients through smooth compliance.
Expert Consultation and Support
With over two decades of regulatory consultancy and over 500 successful CDSCO licensing projects, we offer hands-on assistance in:
- Document preparation and review
- Laboratory coordination and test license applications
- Liaison with CDSCO authorities and notified bodies
- Audit preparedness and risk management
Our clients benefit from streamlined processes, clear timelines, and proactive communication.
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm Class C status and applicable license type.
- Prepare Required Documentation: Begin compiling your Device Master File, Plant Master File, and related QMS documents.
- Apply for MD13 Test License: Submit test license application via the CDSCO MD Online Portal.
- Coordinate Product Testing: Engage CDSCO-approved testing laboratories early.
- Plan for Audit: Select and coordinate with a notified body or CDSCO inspectors.
- Submit Manufacturing License Application: File Form MD7 after successful testing.
Engaging with a seasoned regulatory consultant can significantly reduce compliance risks and expedite licensing. Contact us to initiate your CDSCO licensing journey for your X-ray/MR combined linear accelerator system today.
