CDSCO License for Intravascular Diagnostic Catheter

Comprehensive Guide to CDSCO Licensing for Intravascular Diagnostic Catheters (Class D)

Intravascular Diagnostic Catheters are critical medical devices designed to record intracardiac pressures, sample blood, and introduce substances directly into the heart and blood vessels. Given their high-risk classification (Class D) under Indian regulations, these devices demand stringent oversight to ensure patient safety and regulatory compliance. With over 25 years of experience aiding 500+ companies in securing CDSCO licenses, we bring you an expert roadmap to successfully navigate the licensing process for your Intravascular Diagnostic Catheter.

CDSCO Regulatory Framework for Intravascular Diagnostic Catheters

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India. Intravascular Diagnostic Catheters fall under high-risk Class D devices as per the Medical Device Rules 2017, necessitating a Central Licensing Authority approval through the MD9 license pathway.

The regulatory framework ensures that these devices meet rigorous safety, quality, and performance standards before entering the Indian market. Compliance includes product testing, quality management system implementation, and thorough documentation.

Risk Classification and License Requirements for Class D Devices

Your device is classified as Class D because it is utilized inside the heart and vessels, where failure could result in serious health consequences or death. This classification mandates:

• MD9 Manufacturing License: For manufacturing within India, issued by the Central Licensing Authority.
• MD15 Import License: For importing the device into India.

Both licensing routes require compliance with the Medical Device Rules and relevant Indian and international standards.

Manufacturing License Process (MD9) for Intravascular Diagnostic Catheters

Obtaining an MD9 license involves multiple stages:

1. Test License (Form MD13): Required initially for product testing; typically takes 1.5 to 2 months.
2. Product Testing: Conducted at CDSCO-approved laboratories to validate safety and performance. Refer to the list of Testing Laboratories for authorized centers.
3. Document Preparation: Comprehensive compilation of technical and quality documents.
4. Application Submission (Form MD7): File your manufacturing license application via the CDSCO MD Online Portal.
5. Audit by CDSCO Inspectors: Physical inspection of manufacturing premises, quality systems, and documentation.
6. Resolution of Queries: Address any observations or deficiencies noted by the department or inspectors.
7. Grant of License (Form MD9): Upon satisfactory compliance, the license is issued.

The entire process typically spans 4 to 5 months.

Manufacturing License Documents Required

For your Class D Intravascular Diagnostic Catheter, prepare the following key documents:

• Company Constitution (e.g., MOA, AOA)
• Proof of ownership/lease of manufacturing premises
• Details and qualifications of technical staff
• Fire and Pollution NOCs
• Device Master File (DMF) detailing design, components, manufacturing process, and validation. Our detailed Device Master File guide can assist you.
• Plant Master File (PMF) describing manufacturing environment and facilities. See our Plant Master File guide.
• Essential Principles Checklist confirming compliance with Indian safety standards
• Risk Management File demonstrating hazard analysis and mitigation strategies. Learn more about Risk Management.
• Test Reports from CDSCO-recognized labs
• Device Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485 compliant

Preparing these documents meticulously is crucial to avoid delays.

Import License Process (MD15) for Intravascular Diagnostic Catheters

Importers must secure an MD15 license from the Central Licensing Authority. The process includes:

1. Document Preparation: Gather required certificates and documents.
2. Application Submission (Form MD14): File via the CDSCO MD Online Portal.
3. Review and Query Resolution: Address departmental queries promptly.
4. License Grant (Form MD15): Issued upon approval.

Unlike manufacturing, no test license is required for import licenses.

Import License Documents Required

Key documents include:

• Valid Manufacturing License (MD9) from country of origin
• Free Sale Certificate from the exporting country
• ISO 13485:2016 certification
• CE Certificate or equivalent international approval
• Device Master File and Plant Master File
• Wholesale License in India
• Company Constitution documents

Timeline and Processing Duration

Early preparation of documents and proactive communication with CDSCO can help adhere to these timelines.

Government Fees and Costs

For your Class D Intravascular Diagnostic Catheter:

• MD9 Manufacturing License Fees:

  • Application Fee: ₹50,000
  • Per Product Fee: ₹1,000

• MD15 Import License Fees:

  • Site Fee: $3,000
  • Per Product Fee: $1,500

Additional costs include product testing charges at approved laboratories and fees for audits by notified bodies.

Common Challenges and Solutions

Challenge: Complex Documentation

Solution: Leverage expert consultants and comprehensive guides such as our MD9 License Guide to streamline document preparation.

Challenge: Delays in Product Testing

Solution: Select CDSCO-approved laboratories early. Refer to the Testing Laboratories list and schedule testing promptly.

Challenge: Audit Non-Compliance

Solution: Prepare your facility and QMS thoroughly. Engage with notified bodies or CDSCO inspectors proactively.

Challenge: Query Resolution Delays

Solution: Maintain a dedicated regulatory liaison to address departmental queries swiftly.

Expert Consultation and Support

With over two decades of regulatory expertise, we offer end-to-end support — from document drafting to audit readiness. Our tailored consulting services help you anticipate challenges and expedite approvals, minimizing your time to market.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm Class D status as per CDSCO regulations.
2. Plan Testing: Identify appropriate CDSCO-approved labs and schedule product testing.
3. Prepare Documentation: Compile all required technical and quality documents.
4. Register on CDSCO MD Online Portal: Submit your applications electronically via the CDSCO MD Online Portal.
5. Engage Experts: Consult with experienced regulatory advisors to review your submission.
6. Schedule Audit: Coordinate with CDSCO or notified bodies for timely inspections.
7. Respond Promptly: Address any queries from CDSCO to avoid delays.

By following this strategic approach, your Intravascular Diagnostic Catheter manufacturing or import license application will progress smoothly, ensuring compliance and timely market entry in India.

For personalized assistance or to discuss your specific requirements, contact our regulatory experts today and leverage our proven track record in CDSCO licensing success.