CDSCO License for Applicator for vaginal manual brachytherapy
Medical Device Information
Intended Use
A manual brachytherapy applicator specifically designed for vaginal or transvaginal radiation therapy. A single or module applicator designed to facilitate manual placement (puncture, local placement, endoscopic placement or placement and removal using a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites.
Comprehensive Guide to CDSCO Licensing for Applicator for Vaginal Manual Brachytherapy (Class C Medical Device)
Navigating the Indian regulatory landscape for medical devices can be complex, especially for specialized devices like the Applicator for Vaginal Manual Brachytherapy. This device, designed specifically for manual placement of therapeutic radiation sources in vaginal or transvaginal radiotherapy, falls under Class C risk category according to CDSCO guidelines. With our 25+ years of experience and having assisted over 500 companies, we provide you with a detailed, step-by-step guide to secure your CDSCO license efficiently and compliantly.
CDSCO Regulatory Framework for Radiotherapy Devices
The Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices in India. Radiotherapy devices such as manual brachytherapy applicators are classified as Class C due to their moderate to high risk profile, necessitating rigorous evaluation.
The governing notification for this device is File No. 29/Misc./03/2020-DC (180), dated August 6, 2021, which officially recognizes it within the regulatory framework.
Understanding this classification is critical since it dictates the specific licensing process, fees, and documentation required.
Risk Classification and License Requirements for Applicator for Vaginal Manual Brachytherapy
- Risk Class: C (Moderate to High Risk)
- License Type: MD9 Manufacturing License
- Authority: Central Licensing Authority (CDSCO Headquarters)
Class C devices require a centralized licensing process involving more detailed technical scrutiny and audits compared to Class A or B devices. The MD9 license, applied via Form MD7, is mandatory for manufacturers.
For importers, an MD15 Import License is necessary, but here our focus is primarily on manufacturing.
Manufacturing License Process (MD9) for Class C Devices
The end-to-end manufacturing license process for Class C devices like the brachytherapy applicator typically spans 4 to 5 months. The main stages include:
Test License Acquisition (Form MD13): Before manufacturing license application, you must obtain a test license, which takes approximately 1.5 to 2 months. This allows prototype testing.
Product Testing: Conduct mandatory product testing through government-approved laboratories to validate safety and performance. Refer to the list of testing laboratories for authorized centers.
Document Preparation: Compile comprehensive technical documentation including Device Master File (DMF), Plant Master File (PMF), Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documents.
Application Submission (Form MD7): Submit your application through the CDSCO MD Online Portal.
Inspection and Audit: CDSCO inspectors will audit your manufacturing facility and documentation to ensure compliance.
Query Resolution: Promptly address any queries or observations raised by CDSCO.
Grant of License: Upon successful review and audit, the MD9 manufacturing license is granted.
For detailed guidance on the MD9 process, you can consult our MD9 License Guide.
Manufacturing License Documents Required for Applicator for Vaginal Manual Brachytherapy
To streamline your application, ensure you prepare and submit the following documents:
- Company Constitution Documents: Incorporation certificate, partnership deed, or equivalent.
- Proof of Ownership or Lease of Premises: Legal documents verifying your manufacturing site.
- Technical Staff Qualification Documents: CVs and qualifications of key technical and quality personnel.
- Fire NOC and Pollution Control NOC: Safety and environmental compliance certificates.
- Device Master File (DMF): Detailed device design, specifications, and manufacturing details. Our Device Master File guide explains preparation best practices.
- Plant Master File (PMF): Information about your manufacturing facility and equipment. Learn more with our Plant Master File guide.
- Essential Principles Checklist: Compliance checklist aligned with Indian regulatory requirements.
- Risk Management File: Documented risk analysis and mitigation strategies. Refer to our Risk Management guidance.
- Test Reports: Reports from approved laboratories validating product safety and performance.
- Labels and Instructions for Use (IFU): Samples of product labeling and user manuals.
- Quality Management System (QMS) Documents: ISO 13485:2016 certification and related procedures.
Import License Process (MD15) for Applicator for Vaginal Manual Brachytherapy
If you plan to import this device into India, you must secure an MD15 import license via Form MD14 from the Central Licensing Authority. The process typically takes 5 to 6 months and includes:
- Document preparation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certification, CE Certificate, Device and Plant Master Files, Wholesale License, and Company Constitution documents.
- Application submission through the CDSCO MD Online Portal.
- Review and query resolution by CDSCO.
Note: Unlike manufacturing licenses, no test license is required for import.
For detailed steps, refer to our Import License Guide.
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 3 - 4 weeks |
| Document Preparation | 3 - 6 weeks (varies) |
| MD9 Application Processing | 1.5 - 2 months |
| Total Duration | Approximately 4 - 5 months |
Understanding these timelines allows for effective project planning and resource allocation.
Government Fees and Costs
- MD9 Manufacturing License Fees: Rs 50,000 per application + Rs 1,000 per product.
- Test License Fees: Nominal, as per CDSCO guidelines.
Additional costs to factor in include testing laboratory fees, audit consultancy charges, and internal resource allocation for documentation and compliance.
Common Challenges and Solutions
- Delayed Test Reports: Proactively schedule testing with government-approved labs early; consult the Testing Laboratories list to select labs with faster turnaround.
- Incomplete Documentation: Engage regulatory experts to audit your documents pre-submission.
- Audit Non-Compliance: Prepare your facility according to notified body checklists; check list of notified bodies for accredited auditors.
- Query Resolution Delays: Assign dedicated personnel for prompt communication with CDSCO.
Expert Consultation and Support
With over two decades of regulatory consultancy, we have successfully guided over 500 manufacturers through the CDSCO licensing journey. Our expertise includes:
- End-to-end documentation preparation
- Audit readiness and mock inspections
- Liaison with CDSCO and notified bodies
- Risk management strategy implementation
We recommend engaging expert consultants early to avoid common pitfalls and accelerate your market entry.
Getting Started with Your CDSCO License Application
Assess Device Classification: Confirm your device’s Class C status; you can verify classifications on our Medical Device Classification resource.
Gather Core Documents: Begin compiling company, device, and facility-related documents.
Apply for Test License (MD13): Submit your test license application through the CDSCO MD Online Portal.
Coordinate Product Testing: Book slots with approved testing labs immediately after test license grant.
Prepare and Submit MD9 Application: Post-testing, finalize documentation and apply via Form MD7.
Prepare for Audit: Conduct internal audits and prepare your facility for CDSCO inspection.
Respond to Queries Promptly: Maintain proactive communication with licensing authorities.
Embarking on this journey with thorough preparation and expert guidance significantly enhances your chances of a smooth, timely approval.
For personalized assistance tailored to your vaginal manual brachytherapy applicator, contact us to leverage our 25+ years of regulatory excellence.
