CDSCO License for Carotid Stent System
Medical Device Information
Intended Use
Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization.
Comprehensive Guide to CDSCO Licensing for Carotid Stent System (Class D Medical Device)
The Carotid Stent System is a high-risk Class D medical device designed for patients needing carotid revascularization, especially those at elevated risk from carotid endarterectomy. As a critical interventional cardiology device categorized under catheters, regulatory compliance in India is stringent. With over 25 years of experience assisting 500+ companies in navigating CDSCO licensing, we provide you a detailed roadmap for obtaining your CDSCO license efficiently and compliantly.
CDSCO Regulatory Framework for Carotid Stent System
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Devices Rules 2017. Since the Carotid Stent System is notified under 29/Misc/3/2017-DC (292) dated 06.06.2018, it falls under Class D – the highest risk class requiring meticulous regulatory scrutiny by the Central Licensing Authority (CLA).
This device requires an MD9 manufacturing license for in-country manufacturing or an MD15 import license for importers, both managed via the CDSCO MD Online Portal. Compliance includes proving safety, efficacy, quality management adherence, and thorough documentation.
Risk Classification and License Requirements for Class D Devices
As a Class D device, the Carotid Stent System demands the most stringent regulatory control due to its critical application in vascular interventions. CDSCO mandates:
- MD9 License for manufacturing in India, issued by the Central Licensing Authority.
- MD15 License for importers, also issued by the CLA.
The licensing process involves product testing from government-approved laboratories, a detailed audit, and comprehensive dossier submission.
For detailed device classification insights, refer to our Medical Device Classification guide.
Manufacturing License Process (MD9) for Carotid Stent System
- Test License Application (Form MD13): Before applying for the MD9 license, manufacturers must obtain a test license to conduct product testing. This typically takes 1.5 to 2 months.
- Product Testing: Conduct tests at CDSCO-approved laboratories to demonstrate compliance with Indian standards.
- Documentation Preparation: Compile all required documents including Device Master File and Plant Master File.
- MD9 License Application (Form MD7): Submit the manufacturing license application through the CDSCO MD Online Portal.
- Audit by CDSCO Inspectors: The CLA will audit manufacturing facilities and quality systems.
- Query Resolution: Address any clarifications or deficiencies raised during review.
- License Grant (Form MD9): Upon successful completion, the license is granted.
The entire process typically spans 4 to 5 months.
For a step-by-step breakdown, see our detailed MD9 License Guide.
Manufacturing License Documents Required for Class D Devices
Ensure your dossier includes:
- Company Constitution/Registration Certificate
- Proof of Ownership or Lease of Manufacturing Premises
- Details of Qualified Technical Staff (with relevant qualifications)
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) detailing design, specifications, and manufacturing process (Learn more about DMF)
- Plant Master File (PMF) describing manufacturing facility and equipment (Plant Master File Guide)
- Essential Principles Checklist demonstrating compliance with regulatory requirements
- Risk Management File showing hazard analysis and mitigation (Risk Management insights)
- Test Reports from CDSCO-approved laboratories (Testing Laboratories list)
- Product Labels and Instructions for Use (IFU)
- Quality Management System Documents (ISO 13485:2016 certification recommended)
Import License Process (MD15) for Carotid Stent System
For importers aiming to bring the Carotid Stent System into India, the MD15 license is mandatory. The process includes:
- Preparation of Complete Documentation: Including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, and relevant master files.
- Application Submission (Form MD14) via CDSCO MD Online Portal: No test license is required, but rigorous documentation review is conducted.
- Query Resolution: Timely responses to CDSCO queries ensure smooth processing.
- License Issuance (Form MD15): Typically granted within 5 to 6 months.
Refer to our Import License Guide for comprehensive support.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate or Certificate of Market Authorization
- ISO 13485:2016 Certification
- CE Marking Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale License in India (if applicable)
- Company Constitution and Address Proof
- Product Labels and IFU
Timeline and Processing Duration
| License Type | Process Steps | Duration |
|---|---|---|
| MD9 (Manufacturing) | Test License + Product Testing + Application + Audit + License Grant | 4-5 months |
| MD15 (Import) | Document Preparation + Application + Query Resolution + License Grant | 5-6 months |
Planning ahead is crucial. Start documentation and testing early to avoid delays.
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD9 (Class D) | ₹50,000 | ₹1,000 |
| MD15 (Class D) | $3,000 (per site) | $1,500 (per product) |
Note: Fees are subject to change; always verify on the official CDSCO MD Online Portal.
Common Challenges and Solutions
- Delayed Test Reports: Engage with CDSCO-approved labs early; track progress regularly.
- Incomplete Documentation: Use comprehensive checklists and professional consultation to ensure completeness.
- Audit Non-Compliance: Prepare your manufacturing site and QMS thoroughly; conduct internal audits before CDSCO inspections.
- Query Resolution Delays: Respond promptly with clear, detailed information to avoid procedural setbacks.
Our experience with over 500 successful applications equips us to guide you through these hurdles effectively.
Expert Consultation and Support
Navigating Class D device regulations demands expertise. We offer:
- End-to-end license application assistance
- Gap analysis and document preparation
- Coordination with notified bodies and testing labs
- Pre-audit readiness and mock inspections
Partnering with seasoned consultants significantly reduces approval timelines and compliance risks.
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm Class D status and understand specific regulatory requirements.
- Initiate Test License Application: For manufacturers, apply for the test license (Form MD13) via the CDSCO MD Online Portal.
- Engage with Approved Testing Labs: Schedule product testing early to meet deadlines.
- Prepare Comprehensive Documentation: Utilize templates and guides like our Device Master File and Plant Master File guides.
- Submit Application and Schedule Audit: After document submission, prepare for CDSCO audits and inspections.
- Monitor Application Status and Respond to Queries: Keep track on the portal and provide prompt replies.
By following these practical steps and leveraging our expertise, your Carotid Stent System can gain CDSCO approval efficiently, enabling timely access to the Indian market.
For personalized assistance, contact us to streamline your regulatory journey with confidence.
