CDSCO License for Central circulatory manual brachytherapy therapeutic radionuclide system

Understanding the Central Circulatory Manual Brachytherapy Therapeutic Radionuclide System and Its Regulatory Importance

Central circulatory manual brachytherapy therapeutic radionuclide systems play a crucial role in targeted radiotherapy, delivering precise radiation doses directly within the central circulatory system. Given their high-risk nature—classified as Class D devices by the Central Drugs Standard Control Organisation (CDSCO)—regulatory compliance is stringent to ensure patient safety and device efficacy. Our 25+ years of experience guiding over 500 companies through CDSCO licensing uniquely positions us to help you navigate the complex regulatory landscape for this advanced radiotherapy equipment.

CDSCO Regulatory Framework for Radiotherapy Devices

Radiotherapy devices such as the central circulatory manual brachytherapy therapeutic radionuclide system fall under the ambit of CDSCO’s medical device regulations. As per the CDSCO medical device classification, your device is Class D due to its direct interaction with critical bodily functions and radiation emission risks.

This classification mandates oversight by the Central Licensing Authority, requiring adherence to rigorous documentation, testing, and audit standards to obtain manufacturing and import licenses.

Risk Classification and License Requirements for Class D Devices

Class D devices carry the highest risk category under CDSCO guidelines. Accordingly, manufacturing licenses are issued under the MD9 scheme (application Form MD7), while import licenses are managed through the MD15 license (application Form MD14). Both licenses require detailed technical documentation, stringent quality management systems, and compliance with essential principles.

Manufacturing License Process for Central Circulatory Brachytherapy Systems (MD9)

1. Test License (Form MD13): Before applying for the MD9 manufacturing license, you must obtain a test license to conduct product testing. This step typically takes 1.5 to 2 months.

2. Product Testing: Testing must be conducted at government-approved laboratories listed on the CDSCO website. This ensures your device meets safety and performance parameters.

3. Document Preparation: Prepare comprehensive documentation, including Device Master Files (DMF), Plant Master Files (PMF), Risk Management Files, and Quality Management System (QMS) documents.

4. Application Submission: Submit your MD9 application via the CDSCO MD Online Portal, attaching all required documents.

5. Audit by CDSCO Inspectors: Upon application acceptance, CDSCO conducts an on-site audit to verify compliance with manufacturing standards.

6. Query Resolution: Address any queries raised by CDSCO promptly to avoid delays.

7. Grant of License: Once all requirements are met, the MD9 license (Form MD9) is granted.

For a detailed walkthrough, our clients find the MD9 License Guide invaluable.

Manufacturing License Documents Required

• Company Constitution and Legal Documents
• Proof of Ownership or Rental Agreement of Manufacturing Premises
• Technical Staff Details and Qualifications
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (including design, specifications, and testing protocols) – see our Device Master File guide
• Plant Master File detailing manufacturing processes and facilities – refer to our Plant Master File guide
• Essential Principles Checklist confirming compliance with safety and performance requirements
• Risk Management File demonstrating hazard analysis and mitigation strategies – learn more about Risk Management
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents, preferably ISO 13485:2016 certification

Import License Process for Central Circulatory Brachytherapy Systems (MD15)

Importing Class D devices demands the MD15 license, which is granted by the Central Licensing Authority. The process includes:

1. Document Compilation: Assemble necessary documents, including your manufacturing license, Free Sale Certificate from the country of origin, ISO 13485:2016 and CE certificates, and detailed device and plant master files.

2. Application Submission: Lodge your application on the CDSCO MD Online Portal.

3. Departmental Review and Queries: Respond promptly to any clarifications requested by CDSCO.

4. Grant of MD15 License: After satisfying all regulatory prerequisites, the import license is issued.

For comprehensive details on import licensing, consult our Import License Guide.

Import License Documents Required

• Valid Manufacturing License (MD9) from the country of origin
• Free Sale Certificate or equivalent regulatory approval
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License (if applicable)
• Company Constitution and Ownership Proof

Timeline and Processing Duration

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

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

• MD15 Import License: Approximately 5 to 6 months

Timelines can vary based on document completeness, audit scheduling, and promptness in addressing queries. Early preparation and expert support significantly reduce delays.

Government Fees and Costs

• MD9 Manufacturing License:

  • Application fee: ₹50,000 per application
  • Per product fee: ₹1,000

• MD15 Import License:

  • For Class D devices: USD 3,000 per site
  • USD 1,500 per product

Additional costs may include testing fees at approved laboratories and expenses related to audit preparation.

Common Challenges and Practical Solutions

Challenge: Delays in product testing due to lab backlogs.

Solution: Schedule testing early and select labs from the official Testing Laboratories list with proven turnaround times.

Challenge: Incomplete or inconsistent documentation causing audit observations.

Solution: Utilize detailed checklists and templates for Device Master Files and Risk Management Files, ensuring alignment with CDSCO requirements.

Challenge: Managing complex queries from CDSCO during application review.

Solution: Engage regulatory consultants with domain expertise to provide accurate and timely responses.

Expert Consultation and Support

Our seasoned regulatory team offers tailored support for all stages—from documentation to audit readiness and query management. With over 500 successful CDSCO approvals, we understand the nuances of Class D device submissions and can streamline your approval journey.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device as Class D and review applicable regulations.

2. Initiate the Test License Application: Submit Form MD13 via the CDSCO MD Online Portal to start product testing.

3. Engage a Notified Body for Audits: Identify suitable bodies from the Notified Bodies List early to schedule audits.

4. Prepare Comprehensive Documentation: Leverage our guides on Device Master File and Plant Master File to ensure completeness.

5. Plan for Timelines and Budget: Allocate at least 4-5 months and budget for fees, testing, and consultancy.

6. Partner with Experts: Reach out to experienced consultants to minimize risks and accelerate approvals.

By following these actionable steps and leveraging expert insights, manufacturers and importers can confidently navigate the CDSCO licensing process for central circulatory manual brachytherapy therapeutic radionuclide systems, ensuring timely market entry and regulatory compliance.