CDSCO License for Vascular embolization device
Medical Device Information
Intended Use
It is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors.
Comprehensive Guide to CDSCO Licensing for Vascular Embolization Devices (Class D)
Vascular embolization devices are critical internal prosthetic replacements designed to control hemorrhaging caused by aneurysms and certain tumors. Given their high-risk classification (Class D) under the CDSCO regulatory framework, these devices demand rigorous compliance and thorough documentation before entering the Indian market.
With over 25 years of regulatory consulting experience and more than 500 successful CDSCO license approvals, we provide expert insights to streamline your journey for obtaining the CDSCO manufacturing or import license specific to this device category.
CDSCO Regulatory Framework for Vascular Embolization Devices
The Central Drugs Standard Control Organization (CDSCO) oversees the regulation of medical devices in India, classifying them based on risk. Vascular embolization devices fall under Class D, representing the highest risk category due to their implantable nature and critical physiological impact.
India regulates such devices through the Medical Device Rules, 2017, and notifications such as Notification 29/Misc/3/2017-DC (292) dated 06.06.2018 specifically list vascular embolization devices as internal prosthetic replacements.
This classification means these devices require a Manufacturing License (MD9) or an Import License (MD15) granted by the Central Licensing Authority (CDSCO Headquarters).
Risk Classification and License Requirements
| Device Type | Risk Class | License Type | Licensing Authority | Timeline | Fees (INR) |
|---|---|---|---|---|---|
| Vascular Embolization Device | D | MD9 (Manufacturing) | Central Licensing Authority | 4-5 months | ₹50,000 + ₹1,000 per product |
| Vascular Embolization Device | D | MD15 (Import) | Central Licensing Authority | 5-6 months | Varies by class and product |
Due to their critical use and implantable nature, vascular embolization devices are stringently regulated. The MD9 license applies to manufacturers, while importers must secure the MD15 license.
Manufacturing License Process (MD9) for Class D Devices
Obtaining an MD9 license is a multi-step process handled at the central level:
Test License (Form MD13): Before the manufacturing license, you must obtain a test license valid for 6 months, allowing you to manufacture the device for testing purposes.
Product Testing: Conduct mandatory product testing at CDSCO-approved laboratories to establish compliance with Indian standards.
Documentation Preparation: Compile detailed technical and quality documentation, including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
Application Submission: File the application (Form MD7) for an MD9 license through the CDSCO MD Online Portal.
Inspection & Audit: CDSCO officials conduct a thorough audit of your manufacturing facility and quality systems.
Query Resolution: Address any queries raised by CDSCO inspectors promptly.
License Grant: Upon successful review and inspection, CDSCO issues the MD9 license (Form MD9).
For detailed guidance on MD9 licensing, refer to our MD9 License Guide.
Manufacturing License Documents Required for Vascular Embolization Devices
Ensuring that your documentation is comprehensive and accurate can significantly expedite the approval process. The key documents include:
- Company Constitution and Incorporation Certificate
- Proof of Ownership or Lease of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) – detailed design, specifications, manufacturing processes (Device Master File Guide)
- Plant Master File (PMF) – facility and equipment details (Plant Master File Guide)
- Essential Principles Checklist demonstrating compliance with Indian standards
- Risk Management File reflecting ISO 14971 implementation (Risk Management)
- Product Test Reports from CDSCO-approved testing laboratories (Testing Laboratories)
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents demonstrating ISO 13485 certification
Import License Process (MD15) for Vascular Embolization Devices
For manufacturers or distributors aiming to import vascular embolization devices into India, the MD15 license is mandatory:
Preparation of Documentation: Assemble manufacturing licenses from the country of origin, Free Sale Certificates, CE certificates, and Indian-specific documentation such as Device and Plant Master Files.
Application Submission: Submit Form MD14 for the import license via the CDSCO MD Online Portal.
Review and Queries: CDSCO reviews the application and may raise queries that require prompt resolution.
License Issuance: Upon satisfaction, CDSCO issues the MD15 import license.
Refer to our detailed Import License Guide for stepwise assistance.
Import License Documents Required
- Valid Manufacturing License from the Country of Origin
- Free Sale Certificate or Equivalent
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale Drug License (if applicable)
- Constitution of the Company
- Details of Authorized Indian Agent or Importer
Timeline and Processing Duration
| Process Stage | Approximate Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| Application Processing (MD9) | 2 - 3 months |
| Total Duration | 4 - 5 months (Manufacturing) |
| Import License (MD15) | 5 - 6 months |
Timelines can vary based on document completeness and audit scheduling. Early preparation is key to avoid delays.
Government Fees and Costs
| License Type | Application Fee (INR) | Per Product Fee (INR) |
|---|---|---|
| MD9 (Manufacturing) | ₹50,000 | ₹1,000 |
| MD15 (Import) | Varies by class | Varies by product |
Additional costs include fees for testing, notified body audits, and consultant support if engaged.
Common Challenges and Solutions
Challenge: Delays due to incomplete documentation.
- Solution: Use our comprehensive checklists and pre-application audits to ensure all documents meet CDSCO requirements.
Challenge: Difficulty in scheduling audits with CDSCO or notified bodies.
- Solution: Early engagement and flexible scheduling can help secure timely inspections.
Challenge: Ambiguity in risk management and essential principles compliance.
- Solution: Employ specialized consultants with experience in Class D devices to develop robust Risk Management Files.
Challenge: Testing delays at government-approved labs.
- Solution: Choose labs from the official Testing Laboratories list with proven turnaround times.
Expert Consultation and Support
Our team has guided 500+ companies through the complexities of CDSCO licensing for high-risk devices like vascular embolization devices. We offer:
- Gap assessments of your current documents and quality systems
- Assistance in preparing flawless Device and Plant Master Files
- Coordination with notified bodies and CDSCO inspectors
- End-to-end project management from test license to final approval
Getting Started with Your CDSCO License Application
Evaluate Your Product Classification: Confirm your device class and licensing pathway, referencing the official Medical Device Classification guide.
Prepare Initial Documentation: Begin compiling your Company Constitution, technical staffing details, and premises documentation.
Apply for Test License (MD13): Submit test license application via the CDSCO MD Online Portal to start manufacturing samples for testing.
Select Testing Laboratory: Choose an approved lab early to avoid bottlenecks.
Engage Experienced Consultants: Partner with regulatory experts to navigate the audit and query resolution phases efficiently.
Schedule Audits and Inspections: Coordinate with notified bodies and CDSCO for timely facility audits.
Submit MD9 License Application: Once testing and documentation are complete, apply for the MD9 manufacturing license.
Monitor Application Progress: Regularly check the status on the CDSCO portal and respond promptly to queries.
Navigating the regulatory landscape for Class D vascular embolization devices can be complex, but with the right guidance and preparation, market entry can be smooth and timely. Contact us to leverage our expertise and accelerate your CDSCO licensing journey.
