CDSCO License for Embolic Filter system
Medical Device Information
Intended Use
It is indicated for general use as a guidewire and embolic protection system during angioplasty and stenting procedures in carotid arteries with reference vessel diameters of 2.5 to 5.5mm.
Comprehensive Guide to CDSCO Licensing for Embolic Filter Systems (Class D Medical Device)
As a trusted regulatory consultancy with over 25 years of experience and more than 500 successful CDSCO license approvals, we understand the challenges manufacturers and importers face when entering the Indian medical device market. This guide focuses on the Embolic Filter System — a Class D, high-risk catheter device — providing you with actionable insights into the CDSCO regulatory framework, licensing processes, costs, timelines, and documentation requirements.
Understanding the Embolic Filter System and Its Regulatory Importance
The Embolic Filter System is a critical catheter device used as a guidewire and embolic protection system during angioplasty and stenting in carotid arteries, specifically for vessel diameters between 2.5 to 5.5 mm. Given its vital role in preventing embolic debris during cardiovascular interventions, it is classified as a Class D device under CDSCO, denoting the highest risk category.
This classification subjects it to stringent regulatory scrutiny to ensure safety and efficacy before market authorization in India. Compliance with CDSCO norms not only facilitates legal marketing but also builds trust among healthcare providers and patients.
CDSCO Regulatory Framework for Embolic Filter Systems
The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India. For Class D devices like the Embolic Filter System, the licensing authority is the Central Licensing Authority. The regulatory pathway involves:
- Obtaining a Test License (Form MD13) for product testing
- Product testing at CDSCO-approved laboratories
- Submission of a Manufacturing License application (Form MD7) for the MD9 license
- Audit and inspection by CDSCO officials
- Addressing any queries raised during the review
For imported devices, an Import License (Form MD14 for MD15 license) is mandatory.
Risk Classification and License Requirements for Embolic Filter System
The Embolic Filter System falls under Class D (High Risk) category, per the CDSCO classification notified on 06.06.2018 (Notification 29/Misc/3/2017-DC (292)). This classification requires manufacturers to apply for the MD9 Manufacturing License and importers to obtain the MD15 Import License.
| License Type | Authority | Application Form | Timeline | Fees |
|---|---|---|---|---|
| MD9 (Manufacturing) | Central Licensing | MD7 | 4-5 months | ₹50,000 + ₹1,000 per product |
| MD15 (Import) | Central Licensing | MD14 | 5-6 months | Class D: 1,500/product |
Manufacturing License Process (MD9) for Class D Embolic Filter Systems
Test License Application (Form MD13): Before applying for MD9, manufacturers must obtain a Test License valid for 12 months. This enables product testing at CDSCO-approved labs.
Product Testing: Conduct product testing following standards specified by CDSCO. Refer to the list of CDSCO-approved testing laboratories for selecting a lab.
Documentation Preparation: Compile all technical and quality documents, including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and test reports.
License Application (Form MD7): Submit the MD9 license application via the CDSCO MD Online Portal, attaching all requisite documents.
Audit and Inspection: CDSCO inspectors will conduct a detailed audit of manufacturing facilities and review documentation.
Query Resolution: Address any clarifications or queries raised by CDSCO during the evaluation.
License Grant (Form MD9): Upon satisfactory compliance, the MD9 license is granted.
For a detailed overview, our MD9 License Guide is an excellent resource.
Manufacturing License Documents Required for Embolic Filter Systems
- Company constitution documents (e.g., certificate of incorporation)
- Proof of ownership or lease agreement of manufacturing premises
- Details and qualifications of technical staff
- Fire safety and pollution control clearances
- Device Master File (DMF) detailing design, specifications, and manufacturing processes
- Plant Master File describing manufacturing facility and equipment
- Essential Principles Checklist confirming compliance with Indian regulations
- Risk Management File highlighting hazard analysis and mitigation strategies
- Product test reports from CDSCO-approved labs
- Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents (ISO 13485:2016 certification recommended)
We recommend reviewing our Device Master File Guide and Plant Master File Guide for preparing comprehensive dossiers.
Import License Process (MD15) for Embolic Filter Systems
Importers of Embolic Filter Systems must secure an MD15 license from the central authority. The main steps are:
Document Preparation: Gather required documents, including manufacturing license, free sale certificate, ISO 13485:2016, CE certificate, DMF, Plant Master File, wholesale license, and company constitution.
License Application: Apply online on the CDSCO MD Online Portal using Form MD14.
Department Queries: Respond promptly to any queries from CDSCO.
License Issuance: Receive MD15 import license.
Refer to our detailed Import License Guide for additional insights.
Import License Documents Required
- Valid Manufacturing License (MD9) for the Embolic Filter System
- Free Sale Certificate issued by the country of origin
- ISO 13485:2016 Quality Management System Certificate
- CE Certificate or equivalent regulatory approvals
- Device Master File and Plant Master File
- Wholesale Drug License (if applicable)
- Company constitution and ownership documents
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 1 to 2 months (depending on lab) |
| MD9 License Application | 2 to 3 months (including audit & query resolution) |
| MD15 License Application | 5 to 6 months total |
Overall, expect approximately 4 to 5 months to obtain the MD9 license for manufacturing and 5 to 6 months for the MD15 import license.
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD9 (Manufacturing) | ₹50,000 | ₹1,000 |
| MD15 (Import) | $3,000 per site (Class D) | $1,500 per product |
Additional costs include testing fees at government-approved labs, audit fees charged by notified bodies, and professional consultancy fees if engaged.
Common Challenges and Solutions
Extensive Documentation: High-risk devices require detailed dossiers. Solution: Start documentation early, leverage templates, and consult experts.
Testing Delays: Limited approved labs can create bottlenecks. Solution: Schedule tests well in advance and select labs based on capacity.
Audit Non-Compliance: Facilities may fail initial audits due to minor gaps. Solution: Conduct internal pre-audits and implement corrective actions promptly.
Query Resolution Delays: Slow responses can stall approvals. Solution: Maintain dedicated regulatory teams to address queries swiftly.
Understanding Regulatory Updates: Frequent CDSCO notifications can be confusing. Solution: Subscribe to official updates and consult regulatory experts regularly.
Expert Consultation and Support
Navigating CDSCO licensing for a Class D medical device like the Embolic Filter System is complex. Our seasoned regulatory consultants provide end-to-end support, including:
- Gap analysis and readiness assessment
- Comprehensive dossier preparation
- Liaison with CDSCO and notified bodies
- Assistance with audits and inspections
- Post-approval compliance and vigilance guidance
Our proven track record with 500+ clients ensures your licensing process is efficient and compliant.
Getting Started with Your CDSCO License Application
Assess Your Product Classification: Confirm your device is Class D and requires MD9 and MD15 licenses.
Register on the CDSCO MD Online Portal: Create your account at the CDSCO MD Online Portal to access application forms and submission tools.
Initiate Test License Application (MD13): Begin with obtaining the test license to proceed with product testing.
Compile Required Documentation: Use our guides on Device Master Files and Plant Master Files to prepare robust dossiers.
Schedule Product Testing: Choose an approved testing laboratory early to avoid delays.
Prepare for Audit: Conduct internal audits and readiness checks before CDSCO inspection.
Submit Manufacturing License Application (MD9): Apply online with complete documents and be responsive during the review phase.
Plan for Import License (MD15) Application: Once manufacturing license is granted, proceed with import license application.
Taking these practical steps will streamline your licensing journey and accelerate your Embolic Filter System’s market entry in India.
For personalized assistance or to discuss your regulatory strategy, contact our expert team today and leverage our 25+ years of CDSCO licensing expertise.
