CDSCO License for Central circulatory temporary placement manual brachytherapy therapeutic radionuclide source

Comprehensive Guide to CDSCO Licensing for Central Circulatory Temporary Placement Manual Brachytherapy Therapeutic Radionuclide Source (Class D Device)

Navigating the regulatory landscape for medical devices in India can be complex, especially for high-risk devices like the central circulatory temporary placement manual brachytherapy therapeutic radionuclide source. This device, classified as Class D under CDSCO regulations, plays a critical role in radiotherapy treatments by delivering targeted radiation through temporarily placed radioisotopes. With over 25 years of experience and having supported 500+ companies in securing CDSCO licenses, we provide you with a detailed, practical roadmap to obtain your manufacturing or import license smoothly and efficiently.

CDSCO Regulatory Framework for Class D Radiotherapy Devices

The Central Drug Standard Control Organization (CDSCO) governs the regulation of medical devices in India under the Medical Device Rules, 2017. Devices such as your brachytherapy source are classified as high-risk (Class D) due to their direct impact on vital systems and use of radioactive materials.

The regulatory framework mandates rigorous evaluation, including product testing, documentation, and audits by CDSCO inspectors, before granting manufacturing or import licenses. The specific notification for this device is File No. 29/Misc./03/2020-DC (180), dated 6.8.2021, which provides the regulatory basis for its classification and controls.

Risk Classification and License Requirements

Your device falls under Class D, the highest risk category, requiring a license from the Central Licensing Authority. The applicable license for manufacturing is the MD9 License (Form MD7), while the import license is MD15 (Form MD14).

• Class D devices involve stringent requirements including detailed technical documentation, demonstration of compliance with essential principles, and mandatory audits.
• The license process typically spans 4 to 5 months for manufacturing and 5 to 6 months for import, reflecting the complexity of review and evaluation.

For a comprehensive understanding of device classification, visit our Medical Device Classification guide.

Manufacturing License Process (MD9 License)

Obtaining an MD9 manufacturing license involves several key steps:

1. Test License Application (Form MD13): Before manufacturing, you must apply for a test license, which takes approximately 1.5 to 2 months. This permits limited production for testing purposes.
2. Product Testing: Conduct mandatory testing at CDSCO-approved laboratories to validate safety and performance. Refer to the official Testing Laboratories list.
3. Document Preparation: Compile comprehensive technical files, including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and Essential Principles Checklist.
4. License Application (Form MD7): Submit the manufacturing license application through the CDSCO MD Online Portal.
5. Audit by CDSCO Inspectors: The Central Licensing Authority will conduct an on-site audit to verify compliance with QMS, facility standards, and documentation.
6. Query Resolution: Address any queries or observations raised during the audit promptly.
7. Grant of License (Form MD9): Upon successful completion, the manufacturing license is granted.

Manufacturing License Documents Required

To ensure a smooth application process, prepare the following documents meticulously:

• Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of ownership or lease of manufacturing premises
• Details and qualifications of technical staff
• Fire and Pollution NOCs from relevant authorities
• Device Master File (DMF) detailing design, specifications, manufacturing process, and controls. Our detailed Device Master File guide can assist you.
• Plant Master File (PMF) describing manufacturing facilities and quality control processes. Refer to our Plant Master File Guide
• Essential Principles Checklist demonstrating compliance with safety and performance requirements
• Risk Management File showcasing hazard identification, risk analysis, and mitigation strategies. Learn more about implementing risk management
• Test Reports from government-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485 certified

Import License Process (MD15 License)

For importing your brachytherapy device into India, you must obtain an MD15 license:

1. Document Preparation: Unlike manufacturing, no test license is required. Prepare all necessary technical and regulatory documentation.
2. License Application (Form MD14): Submit your application through the CDSCO MD Online Portal.
3. Queries and Clarifications: Respond to any queries from CDSCO promptly.
4. Grant of License (Form MD15)

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate or equivalent international approvals
• Device Master File and Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution

Timeline and Processing Duration

Plan your project timeline accordingly, allowing extra time for potential audit observations or documentation clarifications.

Government Fees and Costs

• MD9 License:

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

• MD15 License:

  • Class D Devices: $3,000 per site
  • Per Product Fee: $1,500

Note: Fees are subject to change; confirm at the time of application.

Common Challenges and Solutions

• Delays in Testing: Government-approved labs may have backlogs. Plan testing early and consider multiple labs from the Testing Laboratories list.
• Incomplete Documentation: Missing or inconsistent information is a common cause for queries. Use our Device Master File guide and Plant Master File Guide to prepare comprehensive files.
• Audit Non-Compliance: Prepare thoroughly for audits by conducting internal mock audits and ensuring QMS readiness.
• Regulatory Updates: Stay current with notifications such as File No. 29/Misc./03/2020-DC (180) dated 6.8.2021.

Expert Consultation and Support

With decades of experience in CDSCO licensing, our regulatory consultants can help you:

• Prepare and review all documentation
• Liaise with notified bodies and CDSCO officials
• Plan and execute testing strategies
• Conduct internal audits and risk assessments
• Manage application submissions and follow-ups

Our expertise has enabled 500+ companies to successfully navigate the complexities of Indian medical device regulations.

Getting Started with Your CDSCO License Application

1. Assess Classification: Confirm your device is Class D as per CDSCO guidelines.
2. Engage a Regulatory Consultant: Early expert involvement reduces risk of delays.
3. Prepare Documentation: Start compiling your DMF, PMF, Risk Management, and QMS documents.
4. Apply for Test License (for manufacturing): Submit Form MD13 via the CDSCO MD Online Portal to initiate testing.
5. Schedule Testing: Coordinate testing with approved labs.
6. Submit License Application: Once testing is complete and documentation is ready, apply for MD9 or MD15 license.

Embarking on the CDSCO licensing journey for your central circulatory temporary placement manual brachytherapy therapeutic radionuclide source demands careful planning and expert guidance. Contact us to leverage our 25+ years of regulatory expertise and ensure your device reaches the Indian market efficiently and compliantly.