CDSCO License for Applicator for bladder manual brachytherapy
Medical Device Information
Intended Use
A manual brachytherapy applicator designed to facilitate manual placement (puncture or placement and removal using an endoscope or a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites in the bladder.
Comprehensive Guide to CDSCO Licensing for Applicator for Bladder Manual Brachytherapy (Class C Medical Device)
With over 25 years of experience and having supported 500+ companies in navigating the complexities of CDSCO licensing, we provide you a detailed, step-by-step guide to obtaining the mandatory permissions for your Class C medical device — the Applicator for bladder manual brachytherapy. This device plays a critical role in radiotherapy, enabling precise placement of therapeutic radiation sources in the bladder under manual or imaging guidance.
Understanding the Regulatory Importance of Your Device
Medical devices intended for radiotherapy, especially those classified as Class C by the Central Drugs Standard Control Organization (CDSCO), demand rigorous regulatory compliance. Our deep expertise ensures you understand the nuances of Indian regulatory requirements, speeding your market entry without compromising safety or quality.
CDSCO Regulatory Framework for Applicator for Bladder Manual Brachytherapy
Your device falls under the Class C category as per the notified file No. 29/Misc./03/2020-DC (180) dated 6.8.2021. Class C devices, being moderate-to-high risk, require licensing from the Central Licensing Authority via the MD9 manufacturing license pathway.
This framework involves multiple stages — starting from obtaining a test license (Form MD13), product testing by government-approved labs, document preparation, application submission (Form MD7), followed by inspection and audit, and finally, grant of the license (Form MD9).
Risk Classification and License Requirements for Your Device
- Risk Class: C (Moderate to High Risk)
- License Type: MD9 Manufacturing License
- Authority: CDSCO Central Licensing Authority
Class C devices like your brachytherapy applicator require stringent compliance to ensure patient safety, including detailed technical documentation, risk management, and quality management system adherence.
Manufacturing License Process (MD9) for Class C Devices
Test License Application (Form MD13): Begin with applying for a test license, which takes approximately 1.5 to 2 months. This license permits initial manufacturing of the device sample for testing.
Product Testing: Get your device tested at CDSCO-recognized laboratories. You can find the list of approved testing laboratories on the CDSCO portal.
Document Preparation: Assemble all required documents, including technical files, risk management documentation, and quality management certificates.
Application Submission (Form MD7): Submit the MD9 license application via the CDSCO MD Online Portal.
Audit and Inspection: CDSCO inspectors conduct audits of your manufacturing facility and quality systems.
Query Resolution: Respond promptly to any queries raised by the department or inspectors.
Grant of License: Upon successful compliance, the MD9 license is issued.
Manufacturing License Documents Required for Applicator for Bladder Manual Brachytherapy
Ensure you have the following documents ready:
- Company Constitution and Incorporation Certificate
- Proof of Ownership or Lease Agreement for Manufacturing Premises
- Technical Staff Qualification and Experience Certificates
- Fire Safety NOC and Pollution Control Board NOC
- Device Master File (DMF): Detailed design and manufacturing information (Device Master File Guide)
- Plant Master File (PMF): Comprehensive details of manufacturing facilities and quality systems (Plant Master File Guide)
- Essential Principles Checklist compliance report
- Risk Management File adhering to ISO 14971 (Risk Management Guidance)
- Test Reports from CDSCO-Approved Labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System Documents (typically ISO 13485:2016 certification)
Import License Process (MD15) for Applicator for Bladder Manual Brachytherapy
If you plan to import the device, an MD15 import license is mandatory. The process involves:
- Document preparation, including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files.
- Submission of application via the CDSCO MD Online Portal.
- Query resolution and grant of license within approximately 5-6 months.
Import License Documents Required
- Valid Manufacturing License from country of origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale License (if applicable)
- Company Constitution and related corporate documents
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 – 1.5 months |
| Document Preparation | 2 – 3 weeks |
| MD9 License Application Review | 1 – 1.5 months |
| Inspection & Audit | 2 – 3 weeks |
| Query Resolution | 2 – 4 weeks |
| Total Estimated Time | 4 – 5 months |
Government Fees and Costs
- MD9 License Application Fee: ₹50,000 per application
- Product Fee: ₹1,000 per product
- Test License Fee (MD13): Typically ₹5,000 (varies by state)
Note that additional costs may include fees for testing at approved labs and audit fees payable to notified bodies.
Common Challenges and Practical Solutions
- Delayed Test License Approval: Initiate early with complete test license documentation to avoid bottlenecks.
- Incomplete Technical Documentation: Leverage our expertise in preparing comprehensive Device and Plant Master Files to meet CDSCO expectations.
- Inspection Non-Compliance: Conduct internal mock audits to ensure readiness before CDSCO inspection.
- Query Management Delays: Assign dedicated personnel to monitor and respond promptly to CDSCO queries.
Expert Consultation and Support
Our extensive experience with over 500 successful CDSCO licensing projects means we understand the nuances of Class C device approvals, especially for complex radiotherapy applicators. We assist with:
- End-to-end documentation preparation
- Coordination with notified bodies and testing labs
- Application submission and follow-up
- Training for in-house teams on regulatory compliance
Getting Started with Your CDSCO License Application
- Register on the CDSCO MD Online Portal to initiate your application.
- Prepare and submit your Test License (MD13) application to start manufacturing samples.
- Arrange product testing at a CDSCO-approved laboratory.
- Develop your Device Master File and Plant Master File thoroughly, ensuring alignment with regulatory expectations.
- Submit your MD9 license application (Form MD7) once testing and documentation are complete.
- Prepare for audit by conducting internal reviews and ensuring compliance with QMS.
- Respond promptly to any queries to avoid delays.
By following these structured steps and leveraging expert guidance, you can efficiently secure your CDSCO manufacturing license for the Applicator for bladder manual brachytherapy, ensuring swift and compliant market access in India.
For more detailed insights, please explore our dedicated guides on the MD9 license process and medical device classification.
Partner with us to transform your regulatory challenges into opportunities for growth and compliance excellence.
