CDSCO License for Thrombectomy Catheter

Comprehensive Guide to CDSCO Licensing for Thrombectomy Catheters (Class D Medical Devices)

Thrombectomy catheters are critical medical devices designed to treat deep vein thrombosis (DVT) by removing clots from large-diameter upper and lower peripheral veins. Given their life-saving role and inherent risks, these devices are classified as Class D under the Indian CDSCO regulatory framework, demanding stringent licensing and compliance.

With over 25 years of experience helping 500+ companies navigate CDSCO approvals, we provide you with an in-depth, step-by-step guide specifically tailored for Thrombectomy Catheters, enabling smooth market entry in India.

CDSCO Regulatory Framework for Thrombectomy Catheters

The Central Drugs Standard Control Organization (CDSCO) governs the import and manufacture of medical devices in India. Thrombectomy catheters fall under Class D (high-risk) devices as per the Medical Device Classification guidelines, requiring a central licensing authority approval.

The key regulatory steps include obtaining an MD9 Manufacturing License if you plan to manufacture in India or an MD15 Import License if importing the device.

Risk Classification and License Requirements for Thrombectomy Catheters

• Risk Class: D (High risk)
• License Type:
  • Manufacturing: MD9 License (Form MD7)
  • Import: MD15 License (Form MD14)
• Regulatory Authority: CDSCO Central Licensing Authority
• Notification: 29/Misc/3/2017-DC (292), dated 06.06.2018

High-risk devices like thrombectomy catheters require comprehensive technical documentation, clinical evidence, rigorous testing, and detailed audits.

Manufacturing License Process for Class D Devices (MD9 License)

The MD9 licensing process for thrombectomy catheter manufacturing involves the following sequential steps:

1. Test License (Form MD13): Obtain a test license valid for 6 months to produce samples for testing. This typically takes 1.5 to 2 months.
2. Product Testing: Get your thrombectomy catheter tested at CDSCO-approved government laboratories listed in the Testing Laboratories directory.
3. Document Preparation: Compile the Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documentation.
4. License Application (Form MD7): Submit your application online through the CDSCO MD Online Portal with all required documents.
5. Inspection and Audit: CDSCO inspectors conduct facility audits and review product dossiers.
6. Query Resolution: Address any queries raised by the CDSCO or notified bodies promptly.
7. License Grant: Upon satisfactory compliance, the MD9 license is granted.

The total process duration is approximately 4 to 5 months.

Manufacturing License Documents Required for Thrombectomy Catheters

To streamline your MD9 application, prepare the following mandatory documents:

• Company Constitution and Incorporation Certificate
• Proof of ownership or lease of manufacturing premises
• Details and qualifications of technical and managerial staff
• Fire Safety and Pollution Control NOCs
• Device Master File (DMF) detailing design, specifications, and manufacturing processes (refer to our comprehensive Device Master File guide)
• Plant Master File outlining manufacturing infrastructure and facilities (see our Plant Master File Guide)
• Essential Principles Checklist confirming compliance with Indian standards
• Risk Management File documenting hazards, mitigation, and clinical safety (Risk Management Guide)
• Test Reports from government-approved labs
• Product labels and Instructions for Use (IFU)
• Quality Management System documentation, preferably ISO 13485:2016 certification

Import License Process (MD15 License) for Thrombectomy Catheters

If you intend to import thrombectomy catheters, the MD15 license is mandatory. The process is as follows:

1. Document Preparation: Collect the necessary certificates including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, Wholesale License, and company constitution.
2. License Application: Submit Form MD14 through the CDSCO MD Online Portal.
3. Review & Queries: The CDSCO reviews submitted documents and may raise queries.
4. Grant of License: Once satisfied, CDSCO issues the MD15 import license.

The import license process usually takes around 5 to 6 months.

Import License Documents Required

Key documents to include with your MD15 application are:

• Valid manufacturing license from the exporting country
• Free Sale Certificate demonstrating market approval
• ISO 13485:2016 Quality Management System certificate
• CE Certificate or equivalent international approval
• Device Master File and Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution and Registration Documents
• Product labeling and IFU

Timeline and Processing Duration

Planning ahead is crucial, especially for Class D devices, given the complexity of testing and audits.

Government Fees and Costs for Thrombectomy Catheters

• MD9 Manufacturing License:
  • Application fee: Rs. 50,000
  • Product fee: Rs. 1,000 per product
• MD15 Import License:
  • Site fee for Class D: $3000
  • Product fee for Class D: $1500 per product

Additional costs may include testing fees, audit fees from notified bodies (details at Notified Bodies List), and professional consultancy fees.

Common Challenges and Solutions

Challenge 1: Delays in product testing

Testing at government labs can be time-consuming due to high demand.

Solution: Initiate test license application early and consider multiple approved labs from the Testing Laboratories list to reduce bottlenecks.

Challenge 2: Complex documentation requirements

Preparing extensive DMF, PMF, and risk management files can be overwhelming.

Solution: Leverage expert consultants with experience in Class D devices. Our detailed guides on Device Master File and Risk Management are invaluable.

Challenge 3: Audit non-conformities

Facility audits for Class D devices are stringent and may uncover compliance gaps.

Solution: Conduct internal pre-audits and implement corrective actions before CDSCO inspections.

Expert Consultation and Support

Navigating CDSCO licensing for high-risk devices like thrombectomy catheters requires regulatory expertise. With our 25+ years of experience and a track record of 500+ successful approvals, we provide end-to-end support — from document preparation to audit readiness and query responses.

Our services include:

• Customized regulatory strategy
• Preparation of Device and Plant Master Files
• Coordinating product testing and audits
• Liaising with CDSCO and notified bodies
• Training your team on compliance requirements

Getting Started with Your CDSCO License Application

1. Assess your device classification: Confirm your thrombectomy catheter is Class D using the Medical Device Classification tool.
2. Plan timelines: Allocate at least 5 months for manufacturing license or 6 months for import license processes.
3. Compile documentation: Begin gathering all essential documents such as DMF, PMF, and quality certificates.
4. Apply for test license (for manufacturing): Submit Form MD13 via the CDSCO MD Online Portal.
5. Engage notified bodies: If applicable, schedule audits with notified bodies listed here.
6. Coordinate product testing: Book test slots at approved labs early.
7. Submit your license application: Complete Form MD7 (manufacturing) or MD14 (import) on the CDSCO portal.

Embarking on your regulatory journey with clear guidance and expert support ensures timely approval and successful launch of your thrombectomy catheter in India’s burgeoning medical device market.

For personalized assistance and a tailored compliance roadmap, contact our regulatory experts today.