CDSCO License for X-ray/CT combined particle radiotherapy equipment

Comprehensive Guide to CDSCO Licensing for X-ray/CT Combined Particle Radiotherapy Equipment (Class C)

As specialists with over 25 years of experience in medical device regulatory compliance, having successfully guided 500+ companies through the CDSCO licensing process, we understand the complexities involved in bringing advanced radiotherapy equipment like the X-ray/CT combined particle radiotherapy system to the Indian market. This device, classified as Class C due to its critical therapeutic function, requires meticulous adherence to CDSCO’s regulatory framework to ensure patient safety and market authorization.

Introduction to X-ray/CT Combined Particle Radiotherapy Equipment

This sophisticated device integrates particle radiotherapy technology with X-ray CT imaging to facilitate precise radiotherapy planning. Its use in oncology centers demands stringent regulatory oversight, given the high risk associated with radiation exposure and treatment accuracy. The notification governing this device is File No. 29/Misc./03/2020-DC (180), dated 6.8.2021, officially classifying it under Class C in the radiotherapy category.

CDSCO Regulatory Framework for Radiotherapy Devices

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules, 2017. Class C devices such as the X-ray/CT combined particle radiotherapy system are regulated by the Central Licensing Authority. Manufacturers must obtain an MD9 license (manufacturing license for Class C & D devices) before commencing production or sale.

Risk Classification and License Requirements

The device falls under Class C due to its medium to high risk in patient treatment. This classification mandates:

• License Type: MD9 Manufacturing License
• Authority: Central Licensing Authority (CDSCO Headquarters)
• Application Form: MD7 (for MD9 license application)

For more on medical device classification, manufacturers can review the detailed Medical Device Classification guide.

Manufacturing License Process (MD9)

The MD9 license process involves several critical steps:

1. Test License Application (Form MD13): Initially, the manufacturer must secure a test license. This license allows limited production for testing and validation.
2. Product Testing: Conduct product testing at government-approved laboratories to ensure compliance with safety and performance standards.
3. Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System documents.
4. License Application Submission (Form MD7): Submit the MD9 license application via the CDSCO MD Online Portal.
5. Audit and Inspection: CDSCO inspectors conduct a thorough audit of the manufacturing site, quality systems, and product documentation.
6. Query Resolution: Respond promptly to any queries or observations raised during the audit.
7. License Grant: Upon satisfactory compliance, the MD9 license (Form MD9) is granted.

For detailed guidance, see our MD9 License Guide.

Manufacturing License Documents Required

Successful application requires submission of the following key documents:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Details of Qualified Technical Staff (qualification certificates and experience)
• Fire Safety and Pollution Control NOCs
• Device Master File (DMF): Comprehensive technical dossier detailing design, specifications, and manufacturing process. Our Device Master File guide can assist with preparation.
• Plant Master File (PMF): Details on manufacturing facilities and quality systems; refer to our Plant Master File Guide.
• Essential Principles Checklist: Demonstrating compliance with Indian regulatory requirements.
• Risk Management File: Including hazard analysis and mitigation strategies as per ISO 14971. Learn more about Risk Management.
• Test Reports: From government-approved testing laboratories. A list of such labs is available on the CDSCO Testing Laboratories page.
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents: ISO 13485 certification and related quality manuals and procedures

Import License Process (MD15) for Radiotherapy Equipment

If imported, the device requires an MD15 import license granted by CDSCO’s Central Licensing Authority. The process includes:

• Preparation of all relevant documentation including Manufacturing License, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files
• Submission of application on CDSCO MD Online Portal
• Resolution of departmental queries
• License grant within approximately 5-6 months

Further details are outlined in our Import License Guide.

Timeline and Processing Duration

• Test License (MD13): 1.5 to 2 months
• Product Testing: 1 to 1.5 months (depending on lab schedule)
• MD9 License Processing: 2 to 3 months including audit and query resolution
• Total Time: Approximately 4 to 5 months from start to finish

Government Fees and Costs

• Application Fee: Rs. 50,000 per application
• Per Product Fee: Rs. 1,000 per product variant

These fees are payable online during application submission.

Common Challenges and Solutions

Challenge: Delays in test report submission due to lab backlogs.

Solution: Engage with CDSCO-approved testing laboratories early and schedule tests promptly. Check the updated list of labs here.

Challenge: Non-compliance during CDSCO audit.

Solution: Conduct pre-audit internal assessments and ensure comprehensive documentation and staff training. Utilize notified bodies from the official list for voluntary audits.

Challenge: Incomplete risk management documentation.

Solution: Implement a robust risk management process aligned with ISO 14971 standards, as detailed in our Risk Management guide.

Expert Consultation and Support

Navigating the complex regulatory landscape for Class C radiotherapy devices demands expert support. Our team, backed by decades of experience, offers end-to-end assistance—from initial classification and documentation to audit preparation and query resolution—to ensure your CDSCO license is granted smoothly and swiftly.

Getting Started with Your CDSCO License Application

To initiate your licensing journey:

1. Register on the CDSCO MD Online Portal: Begin by creating an account at the CDSCO MD Online Portal.
2. Prepare Your Test License Application: Gather initial documentation to apply for the MD13 test license.
3. Schedule Product Testing: Contact CDSCO-approved labs early to book testing slots.
4. Compile Comprehensive Documentation: Utilize our expert guides for DMF, PMF, and risk management.
5. Engage Regulatory Consultants: Consider professional support to streamline the audit and application process.

By following these strategic steps, manufacturers of X-ray/CT combined particle radiotherapy equipment can confidently navigate CDSCO licensing and successfully enter the Indian market with compliance and efficiency.