CDSCO License for Vena Cava Filter Sets
Medical Device Information
Intended Use
It is indicated for the prevention of recurrent pulmonary embolism via placement in the vena cava to treat various disease conditions.
Comprehensive Guide to CDSCO Licensing for Vena Cava Filter Sets (Class C Medical Device)
As seasoned regulatory consultants with over 25 years of experience and having supported 500+ companies, we understand that navigating the CDSCO licensing process for complex devices like Vena Cava Filter Sets can be challenging. These specialized catheter devices, classified as Class C under the Indian Medical Device Rules, 2017, require careful adherence to regulatory norms to successfully enter the Indian market.
Understanding Vena Cava Filter Sets and Regulatory Importance
Vena Cava Filter Sets are implantable devices intended for the prevention of recurrent pulmonary embolism by placement in the inferior vena cava. Due to their critical application in treating life-threatening conditions, they fall under Class C, denoting a moderate to high risk level. This classification mandates a stringent regulatory pathway involving central licensing authorities to ensure safety, efficacy, and quality.
CDSCO Regulatory Framework for Vena Cava Filter Sets
The Central Drugs Standard Control Organization (CDSCO) governs the import and manufacture of Class C medical devices in India. The 2017 Notification (29/Misc/3/2017-DC (292), dated 06.06.2018) specifically includes Vena Cava Filter Sets under catheter devices, mandating compliance with the Medical Device Rules (MDR) 2017.
Manufacturing licenses for Class C devices are issued under the MD9 license category, while import licenses require an MD15 license from CDSCO’s central licensing authority.
Risk Classification and License Requirements
- Device Name: Vena Cava Filter Sets
- Risk Class: Class C (Moderate to high risk)
- License Type for Manufacturing: MD9 License (Form MD7)
- License Type for Import: MD15 License (Form MD14)
Manufacturing License Process (MD9) for Vena Cava Filter Sets
The MD9 license process is centralized and typically spans 4 to 5 months. It includes the following key steps:
- Test License Application (Form MD13): Before applying for MD9, you must obtain a test license for sample testing. This takes approximately 1.5 to 2 months.
- Product Testing: Conduct mandatory product testing at CDSCO-approved laboratories. Refer to the Testing Laboratories list for accredited facilities.
- Document Preparation: Compile technical and quality documentation including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and Essential Principles Checklist.
- Application Submission (Form MD7): Submit your MD9 application through the CDSCO MD Online Portal.
- Audit and Inspection: CDSCO officials conduct a thorough audit of manufacturing premises and QMS.
- Queries and Clarifications: Respond promptly to any queries raised by CDSCO.
- Grant of License: Upon satisfactory review, the MD9 license is granted.
For an in-depth understanding, our MD9 License Guide details each step.
Manufacturing License Documents Required for MD9
- Company Constitution Documents
- Proof of Ownership or Lease of Manufacturing Premises
- Qualification Certificates of Technical and Quality Staff
- Fire Safety and Pollution Control NOCs
- Device Master File (DMF) – detailing the design, manufacturing process, and testing
- Plant Master File (PMF) – describing premises, equipment, and quality systems
- Essential Principles Checklist confirming compliance with MDR
- Risk Management File as per ISO 14971 standards
- Product Testing Reports from CDSCO-approved laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation such as ISO 13485:2016 certificates
Our detailed guides on the Device Master File and Plant Master File will help you streamline documentation.
Import License Process (MD15) for Vena Cava Filter Sets
Importers of Vena Cava Filter Sets must apply for an MD15 license via the CDSCO central authority. The process generally takes 5 to 6 months and includes:
- Document Preparation: Gather all required compliance and quality certificates, including:
- Valid manufacturing license (MD9) from the country of origin
- Free Sale Certificate
- ISO 13485:2016 certificate
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale license
- Company Constitution
- Application Submission: Submit your MD15 license application (Form MD14) through the CDSCO MD Online Portal.
- Query Resolution: Address any clarifications from CDSCO promptly.
- Grant of License: Once all conditions are satisfied, the MD15 import license is issued.
For full details, please refer to our Import License Guide.
Timeline and Processing Duration
| License Type | Process Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Manufacturing License (MD9) | 4 – 5 months (inclusive of test license and audit) |
| Import License (MD15) | 5 – 6 months |
Government Fees and Costs
| License Type | Application Fee (Rs) | Per Product Fee (Rs) | Notes |
|---|---|---|---|
| MD9 (Manufacturing) | 50,000 | 1,000 | Central Authority |
| MD15 (Import) | Varies by class* | Varies by class* | Central Authority |
*For Class C devices such as Vena Cava Filter Sets, import fees are approximately 1,500 per product.
Budgeting for testing, documentation, and audit-related costs is also essential. We recommend early engagement with notified bodies listed on the CDSCO Notified Bodies List.
Common Challenges and Practical Solutions
- Delay in Product Testing: Selecting CDSCO-approved labs early and submitting complete samples can prevent testing delays.
- Incomplete Documentation: We advise meticulous preparation of DMF, PMF, and Risk Management files, supported by our comprehensive templates.
- Audit Non-Compliance: Conduct internal audits before CDSCO inspections to ensure adherence to QMS and GMP standards.
- Query Resolution Delays: Assign dedicated regulatory personnel to monitor and respond swiftly to CDSCO queries.
Expert Consultation and Support
Our extensive experience with over 500 successful CDSCO licenses for Class C devices enables us to offer tailored support including:
- Gap assessments and readiness audits
- Comprehensive documentation support
- Coordination with notified bodies and testing labs
- End-to-end application filing and follow-up
Getting Started with Your CDSCO License Application for Vena Cava Filter Sets
- Assess Device Classification: Confirm Class C status using the Medical Device Classification tool.
- Prepare Test License Application: Begin with Form MD13 for sample testing.
- Engage Accredited Testing Labs: Identify labs early to avoid bottlenecks.
- Compile Key Documents: Assemble your Device Master File, Plant Master File, Risk Management File, and QMS documentation.
- Submit MD9 Manufacturing License Application: Use the CDSCO MD Online Portal to file Form MD7.
- Plan for Audits and Inspections: Schedule internal quality assessments and prepare for CDSCO inspections.
- For Importers, Collect Import Compliance Documents: Once manufacturing approval is in place, prepare MD15 application.
Our expert team is ready to assist you through each stage, ensuring a smooth and timely approval process. Contact us to leverage our proven strategies and accelerate your market entry for Vena Cava Filter Sets in India.
