CDSCO License for Medical charged- particle radiation therapy system

Comprehensive Guide to CDSCO Licensing for Medical Charged-Particle Radiation Therapy Systems (Class C)

Medical charged-particle radiation therapy systems are advanced radiotherapy devices designed to accelerate high-energy charged particles such as electrons and protons for targeted cancer treatment. Given their critical role in patient care and the complexity involved, these devices fall under Class C risk classification according to the CDSCO framework. Navigating the regulatory landscape to obtain the necessary manufacturing or import licenses can be challenging. Drawing on our 25+ years of experience helping over 500 companies secure CDSCO approvals, this guide provides an expert, step-by-step approach tailored specifically to this device category.

CDSCO Regulatory Framework for Medical Charged-Particle Radiation Therapy Systems

The Central Drugs Standard Control Organization (CDSCO) governs the import, manufacture, and sale of medical devices in India. Since this system is classified under Class C due to its medium-to-high risk profile, the licensing authority is the Central Licensing Authority. Compliance involves adherence to the Medical Device Rules 2017 and subsequent amendments, including notification File No. 29/Misc./03/2020-DC (180) dated 6.8.2021.

Risk Classification and License Requirements

Being a Class C device, the medical charged-particle radiation therapy system requires an MD9 manufacturing license or an MD15 import license:

• Manufacturing License (MD9): For local manufacturers, granted by the CDSCO Central Licensing Authority.
• Import License (MD15): For importers, also issued by the CDSCO Central Licensing Authority.

You can verify the device’s classification and related details on the Medical Device Classification page.

Manufacturing License Process (MD9) for Class C Devices

The entire process typically takes 4 to 5 months and involves several critical steps:

1. Test License (Form MD13): Before applying for the manufacturing license, the applicant must obtain a test license which takes approximately 1.5 to 2 months.

2. Product Testing: The device must be tested in government-approved laboratories. You can consult the list of Testing Laboratories approved by CDSCO.

3. Document Preparation: Comprehensive documentation including Device Master File and Plant Master File preparation.

4. Application Submission (Form MD7): Submit your application through the CDSCO MD Online Portal.

5. Audit: CDSCO inspectors will conduct a thorough audit of your manufacturing facility and quality management system.

6. Query Resolution: Address any queries raised during the audit or application review.

7. License Grant (Form MD9): Upon satisfactory compliance, CDSCO grants the manufacturing license.

For detailed guidance on the MD9 license process, refer to our MD9 License Guide.

Manufacturing License Documents Required

To ensure smooth approval, prepare the following documents:

• Company Constitution (e.g., Incorporation Certificate, Partnership Deed)
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualifications and Experience
• Fire Safety NOC
• Pollution Control NOC
• Device Master File (DMF) covering design, safety, and performance data (Device Master File Guide)
• Plant Master File detailing manufacturing processes and quality control (Plant Master File Guide)
• Essential Principles Checklist
• Risk Management File tailored to charged-particle therapy systems (Risk Management)
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation compliant with ISO 13485:2016

Import License Process (MD15) for Class C Devices

Importers of medical charged-particle radiation therapy systems must apply for the MD15 license. The process usually spans 5 to 6 months and includes:

1. Document Preparation: Assemble required certificates and licenses.

2. Application Submission (Form MD14): File your application online via the CDSCO MD Online Portal.

3. Query Resolution: Respond promptly to any clarifications sought by CDSCO.

4. License Grant (Form MD15): After review, CDSCO issues the import license.

For import license specifics, consult our Import License Guide.

Import License Documents Required

Key documents required include:

• Valid Manufacturing License from the country of origin
• Free Sale Certificate from the country of origin
• ISO 13485:2016 Certificate
• CE Certificate or equivalent regulatory approval
• Device Master File
• Plant Master File
• Wholesale License if applicable
• Company Constitution

Timeline and Processing Duration

Note: The timelines include document review, laboratory testing, audits, and query resolution.

Government Fees and Costs

For Class C devices under the MD9 manufacturing license:

• Application Fee: ₹50,000 per application
• Per Product Fee: ₹1,000

For MD15 import license:

• Site Fee: $3,000
• Per Product Fee: $1,500

These fees are payable online via the CDSCO portal.

Common Challenges and Solutions

Challenge: Delays in laboratory testing due to device complexity.

• Solution: Engage early with CDSCO-approved labs and pre-schedule testing timelines.

Challenge: Incomplete or inconsistent documentation causing audit queries.

• Solution: Maintain a robust Document Management System and cross-verify all filings with regulatory checklists.

Challenge: Non-compliance with risk management requirements.

• Solution: Implement comprehensive risk assessments per ISO 14971 tailored to radiation therapy devices.

Expert Consultation and Support

Given the technical intricacies of medical charged-particle radiation therapy systems and the regulatory scrutiny they attract, expert consultancy can significantly streamline your CDSCO licensing journey. Our team has assisted over 500 manufacturers and importers with customized strategies, documentation support, and audit readiness preparation.

Getting Started with Your CDSCO License Application

1. Classify Your Device Confirming Class C Status: Refer to the Medical Device Classification.

2. Initiate Test License (MD13): Prepare and submit test license application along with initial documentation.

3. Engage CDSCO-Approved Testing Labs Early: Schedule product testing to prevent bottlenecks.

4. Develop Comprehensive Device and Plant Master Files: Utilize our detailed guides for efficient preparation.

5. Submit Applications via the CDSCO MD Online Portal: Ensure all forms (MD7 for manufacturing, MD14 for import) are accurately completed.

6. Prepare for Audits: Coordinate with notified bodies and CDSCO inspectors; ensure QMS and facility compliance.

7. Respond Promptly to Queries: Maintain active communication channels with CDSCO officials.

By following these steps and leveraging expert insights, your pathway to obtaining the necessary CDSCO licenses for your medical charged-particle radiation therapy system will be efficient and compliant. For personalized assistance, reach out to our regulatory consultants who specialize in Class C medical device licensing.

For further information and detailed procedural guidance, visit the CDSCO MD Online Portal.