CDSCO License for Central circulatory general-purpose remote after loading brachytherapy  applicator

Comprehensive CDSCO Licensing Guide for Central Circulatory Remote Afterloading Brachytherapy Applicator

The Central Circulatory General-Purpose Remote Afterloading Brachytherapy Applicator is a sophisticated Class D medical device used in radiotherapy. Designed for temporary implantation, it precisely guides computer-controlled placement and removal of therapeutic radiation sources within the central circulatory system. Given its critical role and high-risk classification, obtaining the appropriate CDSCO license is mandatory before manufacturing or importing this device in India.

CDSCO Regulatory Framework for Class D Radiotherapy Devices

The Central Drugs Standard Control Organisation (CDSCO) governs the regulation of medical devices in India, ensuring safety and efficacy through a robust licensing framework. Class D devices, including high-risk radiotherapy equipment like this brachytherapy applicator, fall under the strictest regulatory controls due to their invasive nature and potential impact on patient health.

Manufacturers and importers must comply with CDSCO's centralized licensing process, which involves detailed documentation, mandatory testing, and audits by notified bodies.

Risk Classification and License Requirements for the Device

Our brachytherapy applicator is classified as Class D under CDSCO’s risk classification system. This classification reflects the device’s critical use in delivering radiation therapy directly into the central circulatory system, demanding stringent quality and safety controls.

For Class D devices, the required license is the MD9 Manufacturing License (application form MD7) for domestic manufacturing, and MD15 Import License (application form MD14) for importing.

• MD9 License: Issued by the Central Licensing Authority for manufacturing Class C and D devices.
• MD15 License: Also issued by the Central Licensing Authority, required for importers.

Manufacturing License Process for Class D Devices (MD9 License)

Obtaining an MD9 license is a comprehensive, multi-step process:

1. Test License (Form MD13): Before manufacturing license application, the manufacturer must obtain a test license, which typically takes 1.5 to 2 months.
2. Product Testing: Conduct testing at CDSCO-approved government laboratories to validate safety and performance.
3. Document Preparation: Compile detailed technical documents including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.
4. Application Submission (Form MD7): Submit the manufacturing license application on the CDSCO MD Online Portal.
5. Inspection and Audit: CDSCO officials conduct a thorough audit of manufacturing facilities and quality systems.
6. Query Resolution: Address any queries from CDSCO or the audit team promptly.
7. License Grant (Form MD9): Upon successful review and inspection, the MD9 license is granted.

Manufacturing License Documents Required

For the Central Circulatory Remote Afterloading Brachytherapy Applicator, the following documents are critical:

• Company Constitution and Legal Status
• Proof of Ownership or Lease Agreement for Manufacturing Premises
• Qualification and Experience Certificates of Technical Staff
• Fire Safety and Pollution Control NOCs
• Device Master File (DMF) detailing design, manufacturing, and testing procedures (Device Master File Guide)
• Plant Master File (PMF) outlining manufacturing environment and controls (Plant Master File Guide)
• Essential Principles Compliance Checklist
• Risk Management File demonstrating hazard analysis and mitigation (Risk Management)
• Test Reports from CDSCO-approved laboratories (Testing Laboratories)
• Product Labels, Instructions for Use (IFU)
• Quality Management System documentation (ISO 13485:2016 compliant)

Import License Process (MD15 License) for Class D Devices

For importers, the MD15 license process involves:

1. Document Compilation: Similar to manufacturing but also includes the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certification, and CE Certificate.
2. Application Submission: Submit Form MD14 on the CDSCO MD Online Portal.
3. Evaluation and Queries: CDSCO reviews submissions and may raise queries.
4. License Issuance: After satisfactory review, MD15 license is granted.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale License for distribution
• Company Constitution and related legal documents

Timeline and Processing Duration

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

  • Test license: 1.5 to 2 months
  • Product testing: 1 month
  • Documentation and application: 2 weeks
  • Audit and query resolution: 1 to 1.5 months

• MD15 Import License: Approximately 5 to 6 months.

  • Document preparation: 1 month
  • Application review and query resolution: 4 to 5 months

Proactive planning and timely response to CDSCO queries can help avoid unnecessary delays.

Government Fees and Costs

• MD9 License Fees:

  • Application Fee: Rs 50,000
  • Per Product Fee: Rs 1,000

• MD15 Import License Fees for Class D devices:

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

Additional costs to consider include testing fees at government-approved labs, audit fees charged by notified bodies, and consultancy fees if engaging regulatory experts.

Common Challenges and Solutions

• Complex Documentation: Many manufacturers struggle with preparing comprehensive DMF and PMF. We recommend using industry-standard templates and consulting our Device Master File guide for best practices.

• Testing Delays: Government labs have limited capacity. Plan testing well in advance and consider pre-audit consultations.

• Audit Non-Compliance: Ensure your Quality Management System aligns with ISO 13485:2016 and conduct internal pre-audits to identify gaps before CDSCO inspections.

• Slow Query Resolution: Maintain clear and prompt communication with CDSCO to expedite responses.

Expert Consultation and Support

With over 25 years of experience supporting 500+ medical device companies, we offer specialized regulatory consulting for Class D radiotherapy devices. Our services include:

• End-to-end license application preparation
• Device Master File and Plant Master File creation
• Coordination with notified bodies (Notified Bodies List)
• Pre-audit readiness assessments
• Liaison with CDSCO for expedited processing

Partnering with us can significantly reduce your regulatory burden and accelerate market entry.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm Class D status based on intended use and risk.
2. Begin Documentation: Develop your Device Master File, Plant Master File, Risk Management File, and QMS documents.
3. Apply for Test License (if manufacturing): Submit Form MD13 through the CDSCO MD Online Portal.
4. Schedule Product Testing: Engage with CDSCO-approved testing laboratories early.
5. Prepare for Audit: Conduct internal audits and ensure compliance with regulatory standards.
6. Submit Application: File Form MD7 for manufacturing or MD14 for import license on the CDSCO portal.
7. Monitor Application Progress: Respond promptly to queries and prepare for inspections.

Starting early and working with experienced consultants can make this complex process manageable and efficient. Contact us to schedule a personalized consultation and ensure your Central Circulatory Remote Afterloading Brachytherapy Applicator gains timely CDSCO approval for the Indian market.