CDSCO License for Central circulatory permanent implant manual brachytherapy therapeutic radionuclide source

Introduction to Central Circulatory Permanent Implant Manual Brachytherapy Therapeutic Radionuclide Source and Regulatory Importance

The central circulatory permanent implant manual brachytherapy therapeutic radionuclide source is a highly specialized medical device designed for permanent placement within the central circulatory system to deliver targeted radiotherapy. These devices, which include forms such as microspheres, globes, stents, seeds, or wires, utilize natural or accelerator-produced radioisotopes to generate low-energy photons, beta particles, or alpha particles. Their complex nature and critical therapeutic role in cancer treatment place them under the highest regulatory scrutiny.

In India, the Central Drugs Standard Control Organization (CDSCO) governs the approval and licensing of such Class D medical devices, ensuring safety, efficacy, and quality for patient use. Compliance with CDSCO regulations is mandatory before manufacturing or importing these devices. With over 25 years of experience and having successfully assisted 500+ companies, we provide comprehensive insights to navigate this rigorous process efficiently.

CDSCO Regulatory Framework for Class D Radiotherapy Devices

Class D devices, like the brachytherapy therapeutic radionuclide source, fall under the highest risk category due to their implantable nature and use of radioactive materials. The CDSCO oversight for Class D devices is centralized, handled by the Central Licensing Authority, reflecting the critical need for stringent evaluation.

These devices are regulated under the Medical Device Rules (MDR) 2017 and subsequent amendments, which require manufacturers and importers to obtain an MD9 manufacturing license or MD15 import license before market entry. The regulatory framework ensures compliance with quality management systems (ISO 13485), radiation safety standards, and device-specific performance criteria.

Risk Classification and License Requirements for the Device

• Risk Class: D (Highest risk)
• License Type: MD9 Manufacturing License (for domestic manufacturers), MD15 Import License (for importers)
• Regulatory Authority: CDSCO Central Licensing Authority

Given the permanent implant and radioactive nature of this brachytherapy source, it is classified under Class D, which mandates a stringent review process including detailed technical documentation, testing, and audits.

Manufacturing License Process (MD9) for Class D Devices

The MD9 license process for Class D devices involves several sequential steps:

1. Test License (Form MD13): Before full manufacturing license application, obtain a Test License allowing sample production for testing. This typically takes 1.5 to 2 months.

2. Product Testing: Conduct mandatory product testing at CDSCO-approved laboratories. Refer to the Testing Laboratories list for accredited facilities.

3. Document Preparation: Compile comprehensive documentation including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documentation.

4. License Application (Form MD7): Submit the MD9 license application through the CDSCO MD Online Portal.

5. Inspection & Audit: Undergo an on-site audit by CDSCO inspectors to verify compliance with manufacturing practices and documentation.

6. Query Resolution: Respond promptly to any queries raised by the CDSCO or auditors.

7. License Grant: Upon satisfactory completion of all requirements, the MD9 license is issued.

For a detailed walkthrough, our MD9 License Guide offers step-by-step assistance.

Manufacturing License Documents Required for Class D Radiotherapy Devices

Documentation is critical and must be meticulously prepared. Required documents include:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualification and Experience Certificates
• Fire Safety NOC and Pollution Control NOC
• Device Master File (DMF): Detailed design, materials, and manufacturing process documentation. See our Device Master File Guide.
• Plant Master File (PMF): Information on manufacturing facilities and quality systems. Reference our Plant Master File Guide.
• Essential Principles Compliance Checklist
• Risk Management File: Addressing device-specific risks; follow best practices as described in our Risk Management guide.
• Test Reports: From CDSCO-approved labs validating safety and efficacy.
• Labels and Instructions for Use (IFU): Compliant with MDR requirements.
• Quality Management System Documents: ISO 13485:2016 certification and related SOPs.

Import License Process (MD15) for Class D Devices

For importers of this device, the MD15 license process includes:

1. Document Preparation: Assemble required documents such as manufacturing license, free sale certificate from the country of origin, ISO 13485 and CE certificates, DMF, PMF, wholesale license, and company constitution.

2. Application Submission: Apply via the CDSCO MD Online Portal using Form MD14.

3. Department Review and Query Resolution: Respond to any queries raised by CDSCO.

4. Grant of MD15 License: After thorough evaluation, the import license is granted.

Unlike manufacturing licenses, no test license or product testing within India is mandatory before MD15 application, but CDSCO may request samples for testing.

Our Import License Guide provides comprehensive support for this process.

Import License Documents Required for Class D Radiotherapy Devices

Key documents needed for MD15 application include:

• Valid Manufacturing License (MD9) from country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate or Equivalent Regulatory Approval
• Device Master File and Plant Master File
• Wholesale Drug License
• Company Constitution and Address Proof

Ensure all certificates are up to date and notarized if required.

Timeline and Processing Duration for Class D Device Licensing

• MD9 Manufacturing License: Approximately 4 to 5 months total.

  • Test License (MD13): 1.5 to 2 months
  • Product Testing: 1 to 1.5 months
  • Audit and License Grant: 1.5 to 2 months

• MD15 Import License: Approximately 5 to 6 months.

These timelines can vary depending on the completeness of documentation and timely response to queries.

Government Fees and Costs for Class D Device Licensing

• MD9 Manufacturing License Fees:

  • Rs. 50,000 per application
  • Rs. 1,000 per product

• MD15 Import License Fees:

  • Rs. 3,000 per site
  • Rs. 1,500 per product

Note: Additional costs include testing fees at accredited laboratories, audit fees, and consultant charges if applicable.

Common Challenges and Practical Solutions

• Complex Documentation: Preparing comprehensive DMF and PMF can be overwhelming. Utilize templates and expert guidance to ensure compliance.

• Delays in Testing: Coordinate early with CDSCO-approved testing labs to avoid bottlenecks.

• Audit Non-compliance: Conduct internal pre-audit assessments to identify gaps.

• Query Management: Maintain prompt and clear communication with CDSCO officials to resolve queries swiftly.

• Regulatory Updates: Stay informed on MDR amendments and notifications, such as File No. 29/Misc./03/2020-DC (180) dated 6.8.2021 relevant to radiotherapy devices.

Expert Consultation and Support

Navigating the CDSCO licensing for Class D devices demands specialized knowledge. Our 25+ years of experience have equipped us to assist clients through all phases—from document preparation, testing coordination, audit readiness, to final submission. We ensure your application aligns perfectly with regulatory expectations, minimizing delays and maximizing approval success.

Getting Started with Your CDSCO License Application

1. Identify Your Device Risk Class: Confirm Class D status and device categorization.

2. Gather Preliminary Documentation: Start with corporate, technical, and facility documents.

3. Engage with CDSCO-Approved Testing Labs: Schedule product testing early.

4. Apply for Test License (if manufacturing): Submit Form MD13 via the CDSCO MD Online Portal.

5. Prepare Device and Plant Master Files: Consult our guides for detailed preparation.

6. Plan for Audit: Arrange internal audits and staff training.

7. Submit Application: Complete and submit the MD9 or MD15 application forms online.

8. Track Application Status: Regularly monitor and respond to queries.

By following these actionable steps and leveraging expert support, manufacturers and importers can efficiently bring the central circulatory permanent implant manual brachytherapy therapeutic radionuclide source to the Indian market, ensuring compliance and patient safety.