CDSCO License for Central circulatory remote after loading brachytherapy therapeutic radionuclide source

Understanding the Central Circulatory Remote After Loading Brachytherapy Therapeutic Radionuclide Source

The Central Circulatory Remote After Loading Brachytherapy Therapeutic Radionuclide Source is a sophisticated radiotherapy medical device classified under Class D by CDSCO, India’s regulatory authority for medical devices. This device plays a critical role in cancer treatment by delivering precise radiation doses using natural or accelerator-produced radioisotopes to the central circulatory system. Due to its high-risk nature and potential impact on patient safety, strict regulatory compliance is mandatory for manufacturing or importing this device into India.

As regulatory consultants with over 25 years of experience and a track record of assisting 500+ companies in obtaining CDSCO licenses, we provide detailed insights and practical guidance tailored specifically for this device type.

CDSCO Regulatory Framework for Radiotherapy Devices in Class D

This device falls under the Radiotherapy category and is notified under File No. 29/Misc./03/2020-DC (180) dated 6.8.2021. According to the CDSCO classification, any Class D medical device—including high-risk therapeutic radiation sources—requires a manufacturing license known as the MD9 license granted by the Central Licensing Authority.

The MD9 license process is rigorous due to the device’s critical function and risk profile. It ensures compliance with safety, efficacy, quality management, and radiation protection standards before market authorization.

Risk Classification and License Requirements for Your Device

• Device Name: Central Circulatory Remote After Loading Brachytherapy Therapeutic Radionuclide Source
• Risk Class: D (high risk)
• Regulatory License Required: MD9 Manufacturing License (Form MD7)
• Licensing Authority: Central Licensing Authority (CDSCO Headquarters)

For Class D devices, the MD9 manufacturing license is mandatory for manufacturing within India, while an MD15 Import License is required for importers.

Manufacturing License Process (MD9) for Class D Devices

1. Test License Application (Form MD13): Initiate with a test license application, which takes approximately 1.5 to 2 months to process. This step allows limited manufacture for testing and validation.
2. Product Testing: Obtain product testing from CDSCO-approved government laboratories. Testing confirms product compliance with applicable standards. The list of approved testing laboratories is accessible on the CDSCO portal.
3. Document Preparation: Compile comprehensive documentation including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, QMS documents, and others.
4. License Application Submission (Form MD7): Submit the MD9 application through the CDSCO MD Online Portal with all supporting documents.
5. CDSCO Audit and Inspection: CDSCO inspectors conduct an onsite audit verifying compliance with manufacturing practices and documentation.
6. Query Resolution: Address any queries or deficiencies raised by CDSCO or auditors promptly.
7. Grant of License (Form MD9): Upon successful inspection and document review, the manufacturing license is granted.

The entire process typically spans 4 to 5 months from test license initiation to final license grant.

Manufacturing License Documents Required for MD9

• Company Constitution Documents (e.g., Memorandum of Association, Articles of Association)
• Proof of Ownership or Tenancy of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing device design, specifications, and manufacturing processes (see our Device Master File guide)
• Plant Master File describing the manufacturing facility and environment (refer to our Plant Master File guide)
• Essential Principles Compliance Checklist
• Risk Management File demonstrating adherence to international standards (ISO 14971) and Indian regulations (Risk Management insights)
• Test Reports from CDSCO-approved laboratories
• Device Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485:2016 certified preferred)

Import License Process (MD15) for Class D Devices

For importers of the Central Circulatory Remote After Loading Brachytherapy device, the MD15 Import License is mandatory. The process includes:

1. Document Compilation: Prepare documents such as existing manufacturing license, Free Sale Certificate, ISO 13485 certification, CE certificates, Device and Plant Master Files, Wholesale Drug License, and Company Constitution.
2. Application Submission: Apply using Form MD14 through the CDSCO MD Online Portal.
3. Department Review: CDSCO reviews the application and may raise queries.
4. License Grant: Upon satisfactory review, the MD15 license is granted.

The import license process usually takes 5 to 6 months.

Import License Documents Required for MD15

• Valid Manufacturing License for the device from the country of origin
• Free Sale Certificate issued by the competent authority of the exporting country
• ISO 13485:2016 Certification
• CE Certificate or equivalent international approval
• Device Master File and Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution and address proof

Timeline and Processing Duration Summary

Government Fees and Costs

Note: Fees are payable online with the application through the CDSCO portal.

Common Challenges and Practical Solutions

Challenge 1: Delays in Product Testing

Testing at government-approved labs can be time-consuming due to high demand. Early scheduling and parallel documentation preparation can reduce overall delays.

Challenge 2: Incomplete Documentation

Missing or inconsistent documents cause repeated queries. Use detailed checklists and expert review to ensure completeness before submission.

Challenge 3: Audit Non-Compliance

Audit failures often stem from inadequate QMS implementation or facility issues. Conduct internal mock audits and corrective actions prior to CDSCO inspection.

Challenge 4: Regulatory Updates

Regulations evolve; staying current is critical. Subscribe to CDSCO updates and leverage expert consultancy to adapt promptly.

Expert Consultation and Support

Navigating the MD9 licensing pathway for a high-risk radiotherapy device requires specialized knowledge. Our consultancy has successfully assisted over 500 manufacturers and importers with:

• Comprehensive gap analysis
• Preparation of Device and Plant Master Files
• Risk management system implementation
• Coordination with notified bodies and testing labs
• Handling CDSCO queries and audit readiness

We ensure your application is robust, compliant, and optimized for faster approval.

Getting Started with Your CDSCO License Application

1. Assess Your Device Risk Classification: Confirm your device’s Class D status using the Medical Device Classification resource.
2. Prepare Test License Application: File Form MD13 for test license on the CDSCO MD Online Portal to initiate product testing.
3. Engage Approved Testing Labs: Coordinate testing early using the official list of testing laboratories.
4. Compile Key Documentation: Develop your Device Master File, Plant Master File, Risk Management File, and QMS documents with expert guidance.
5. Schedule Pre-Audit Reviews: Conduct internal audits and pre-inspection readiness checks.
6. Submit the MD9 License Application: Use Form MD7 on the CDSCO MD Online Portal once testing and documentation are complete.

Starting with these actionable steps will position your organization for a smooth and successful licensing journey.

For detailed support tailored to the Central Circulatory Remote After Loading Brachytherapy Therapeutic Radionuclide Source, contact our regulatory experts to leverage 25+ years of experience in CDSCO licensing.

For further reading: Explore our in-depth guides on MD9 License, Device Master Files, and Risk Management to enhance your compliance strategy.