CDSCO License for Blood vessel manual brachytherapy applicator
Medical Device Information
Intended Use
A manual brachytherapy applicator designed exclusively for blood vessel radiotherapy. Most commonly, it is used to prevent formation of plaque, stenosis and restenosis in blood vessels after surgery. A single or module device designed to facilitate manual placement (placement and removal under endoscopy or using an image diagnostic system) of single or multiple therapeutic radiation sources in the treatment site.
Introduction to Blood Vessel Manual Brachytherapy Applicator and Regulatory Importance
The Blood Vessel Manual Brachytherapy Applicator is a sophisticated Class D medical device designed specifically for radiotherapy applications targeting blood vessels. It plays a critical role in preventing plaque formation, stenosis, and restenosis after vascular surgeries by enabling manual placement of therapeutic radiation sources. Given its high-risk nature due to direct radiation exposure and implantation in sensitive vascular tissues, stringent regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) is essential to ensure safety, efficacy, and quality.
At our consultancy, with over 25 years of experience and over 500 successful CDSCO licensing projects, we understand the nuanced regulatory landscape surrounding Class D devices like this applicator. Our detailed guidance will help manufacturers and importers navigate the complex MD9 license process seamlessly.
CDSCO Regulatory Framework for Blood Vessel Manual Brachytherapy Applicator
This device falls under the Radiotherapy category and is classified as a Class D medical device under the CDSCO medical device classification system, reflecting the highest risk category due to its direct radiation application. The regulatory framework mandates strict compliance with quality, safety, and performance standards as per the Medical Device Rules 2017.
The device is notified under File No. 29/Misc./03/2020-DC (180), dated 6.8.2021, which means it requires prior approval from the Central Licensing Authority (CLA) before manufacturing or importing into India.
Risk Classification and License Requirements
As a Class D device, the Blood Vessel Manual Brachytherapy Applicator requires a MD9 Manufacturing License issued by the CDSCO Central Licensing Authority. This process involves comprehensive technical documentation, product testing, and regulatory audits.
- MD9 License: Mandatory for Class C and D devices
- Application Form: MD7
- Licensing Authority: Central CDSCO office
- Typical timeline: 4-5 months from application to grant
For importers, the MD15 Import License is required, which also involves detailed documentation and compliance verification.
Manufacturing License Process (MD9)
The MD9 license process for this device involves multiple steps:
- Test License (Form MD13): Apply for a test license to conduct initial product testing; typically takes 1.5 to 2 months to obtain.
- Product Testing: Conduct mandatory testing at CDSCO-approved laboratories to demonstrate compliance with essential principles and performance standards. Refer to the Testing Laboratories list for accredited labs.
- Documentation Preparation: Compile required documents including technical files, quality management system details, and risk management files.
- MD9 License Application (Form MD7): Submit the application for the manufacturing license through the CDSCO MD Online Portal.
- Audit and Inspection: CDSCO officials conduct detailed audits and inspections of manufacturing facilities and documentation.
- Query Resolution: Address any observations or queries raised during audits promptly.
- License Grant: Once compliance is verified, CDSCO issues the MD9 manufacturing license.
Manufacturing License Documents Required
Manufacturers should prepare the following critical documents to ensure a smooth application process:
- Company Constitution (e.g., Memorandum & Articles of Association)
- Proof of ownership/lease of manufacturing premises
- Technical personnel qualifications and experience
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) detailing design, materials, and manufacturing process (see our comprehensive Device Master File guide)
- Plant Master File (PMF) showcasing infrastructure and equipment (refer to our Plant Master File Guide)
- Essential Principles Compliance Checklist
- Risk Management File compliant with ISO 14971 (Risk Management guidance)
- Product Test Reports from CDSCO-approved laboratories
- Labels and Instructions for Use (IFU)
- Quality Management System documents (ISO 13485:2016 certification strongly recommended)
Import License Process (MD15)
For importers intending to bring the Blood Vessel Manual Brachytherapy Applicator into India, the MD15 license is mandatory. The process is as follows:
- Document Preparation: Collect all relevant documents including manufacturing license, Free Sale Certificate from country of origin, ISO 13485:2016 certificate, CE Certificate, Device and Plant Master Files, and Wholesale License.
- Application Submission: Submit the application via the CDSCO MD Online Portal using Form MD14.
- Review and Queries: CDSCO reviews the application and may raise queries.
- Grant of MD15 License: Upon satisfactory compliance, the import license is issued.
Import License Documents Required
- Valid Manufacturing License for the device
- Free Sale Certificate from the exporting country
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale License for distribution
- Company Constitution
Timeline and Processing Duration
| License Type | Processing Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| MD9 Manufacturing License | 4 - 5 months (including test license and audit) |
| MD15 Import License | 5 - 6 months |
Manufacturers should plan for approximately 4-5 months for the entire MD9 license process, inclusive of testing, documentation, and audit. Importers should anticipate 5-6 months for MD15 license issuance.
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD9 Manufacturing License | Rs 50,000 | Rs 1,000 |
| MD15 Import License | Varies by risk class; for Class D devices typically $3000 per site | $1,500 per product |
Additional costs include fees for product testing at government-approved labs and audit charges by notified bodies.
Common Challenges and Solutions
- Delayed Testing Results: Coordinate early with notified testing labs and submit samples promptly.
- Incomplete Documentation: Utilize comprehensive checklists and consult experienced regulatory professionals to avoid rejections.
- Audit Non-conformities: Conduct internal pre-audits and corrective action plans to ensure compliance.
- Query Resolution Delays: Respond to CDSCO queries thoroughly and within stipulated timelines to avoid delays.
Our proven track record demonstrates that proactive planning and expert support significantly reduce processing times and complications.
Expert Consultation and Support
Navigating the MD9 licensing process for a Class D device like the Blood Vessel Manual Brachytherapy Applicator requires specialized knowledge and experience. We provide end-to-end consultancy services including:
- Gap analysis and readiness assessment
- Documentation preparation and review
- Coordination with notified bodies and testing labs
- Audit preparation and support
- Regulatory submission and follow-up
Our expertise ensures your application meets all regulatory expectations, minimizing risks of rejection or delays.
Getting Started with Your CDSCO License Application
To initiate your CDSCO MD9 license application for the Blood Vessel Manual Brachytherapy Applicator:
- Register on the CDSCO MD Online Portal: Create your account and familiarize yourself with the interface. Access here.
- Obtain Test License (MD13): Prepare and submit your test license application promptly to begin product testing.
- Engage with Approved Testing Laboratories: Coordinate testing early to avoid bottlenecks.
- Prepare Comprehensive Documentation: Leverage our Device Master File and Plant Master File guides to assemble technical files.
- Plan for Audit: Schedule pre-audit assessments and consult the list of notified bodies for audit requirements.
- Submit Your MD9 License Application (Form MD7): Once all prior steps are complete and testing is successful, file your application via the portal.
By following these practical steps and leveraging our regulatory expertise, you can confidently enter the Indian market with your Blood Vessel Manual Brachytherapy Applicator, ensuring compliance and timely license approval.
