CDSCO License for Micro-catheter

Comprehensive Guide to CDSCO Licensing for Micro-catheter (Class C Medical Device)

Introduction: Understanding Micro-catheter and Its Regulatory Importance

Micro-catheters are specialized medical devices designed for accessing peripheral and neurovasculature to enable controlled selective infusion of therapeutic agents like embolization materials or diagnostic agents such as contrast media. Given their critical role in minimally invasive procedures, regulatory oversight is stringent to ensure patient safety and device efficacy.

In India, the Central Drugs Standard Control Organization (CDSCO) governs medical device registration and licensing under the Medical Device Rules, 2017. For manufacturers and importers of Class C devices like micro-catheters, obtaining the appropriate CDSCO license is not just mandatory but a vital step toward market access and trust-building with healthcare providers.

CDSCO Regulatory Framework for Micro-catheters

Micro-catheters fall under the 'catheter' category and are classified as Class C devices due to their invasive nature and involvement with critical anatomical regions. Their regulation is outlined under Notification 29/Misc/3/2017-DC (292) dated 06.06.2018. This classification dictates the licensing pathway, compliance requirements, and post-market surveillance obligations.

Risk Classification and License Requirements for Micro-catheters

• Risk Class: Class C
• Applicable License: MD9 Manufacturing License (Central Licensing Authority)
• Application Form: MD7

Class C devices require a more rigorous review process involving central CDSCO authorities, including testing, audits, and comprehensive documentation compared to lower risk classes.

For a detailed understanding of device classification, manufacturers can refer to the Medical Device Classification guide.

Manufacturing License Process for Micro-catheters (MD9 License)

Our experience assisting over 500 companies reveals the following practical pathway for obtaining an MD9 license for Class C devices like micro-catheters:

1. Test License (Form MD13): Initiate by applying for a test license which grants permission to manufacture prototypes for testing. This step typically takes 1.5 to 2 months.
2. Product Testing: Submit the micro-catheter samples to a CDSCO-recognized testing laboratory for compliance verification. You can find approved labs on the CDSCO Testing Laboratories list.
3. Document Preparation: Compile comprehensive technical documentation including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and QMS (Quality Management System) documents.
4. MD9 Application Submission: File the MD9 manufacturing license application (Form MD7) through the CDSCO MD Online Portal.
5. CDSCO Inspection and Audit: The central CDSCO authority will conduct an on-site audit to verify compliance. This includes a thorough review of manufacturing processes, facilities, and documentation.
6. Query Resolution: Address any observations or questions raised by CDSCO inspectors promptly.
7. Grant of License: Upon successful audit and document verification, CDSCO grants the MD9 license (Form MD9), allowing commercial manufacturing.

Manufacturing License Documents Required for Micro-catheters

The documentation demands are comprehensive and critical for a successful application:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualification and Experience Certificates
• Fire NOC and Pollution Control Board NOC
• Device Master File: Detailing design, materials, and manufacturing processes. Our Device Master File guide offers practical templates.
• Plant Master File: Documentation of manufacturing facilities and environmental controls; see our Plant Master File guide.
• Essential Principles Compliance Checklist
• Risk Management File aligned with ISO 14971 standards (Risk Management Guidance)
• Product Test Reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485:2016 certification

Import License Process for Micro-catheters (MD15 License)

If importing micro-catheters into India, an MD15 import license is mandatory. The process, managed by the Central Licensing Authority, includes:

• Document preparation including the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certificate, CE Certificate (if applicable), Device Master File, Plant Master File, Wholesale License, and Company Constitution.
• Application submission through Form MD14 on the CDSCO MD Online Portal.
• CDSCO review and queries resolution.
• License grant (Form MD15) typically within 5-6 months.

For a full walkthrough, consult our Import License Guide.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License (if applicable)
• Company Constitution

Timeline and Processing Duration

Government Fees and Costs

• Test License (MD13): Typically includes nominal fees depending on application specifics.
• MD9 Manufacturing License:
  • Rs 50,000 per application
  • Rs 1,000 per product

Additional costs to consider:

• Product testing fees at government-approved labs
• Notified Body audit fees
• Consultancy and documentation preparation fees

Budgeting for these expenses upfront ensures smoother project planning and avoids surprises.

Common Challenges and Solutions

Challenge: Delays in product testing due to lab backlogs.

Solution: Engage with CDSCO-approved labs early, submit samples promptly, and follow up regularly.

Challenge: Incomplete or inconsistent documentation causing audit observations.

Solution: Utilize comprehensive document checklists and leverage expert consultants familiar with CDSCO expectations.

Challenge: Query resolution delays due to inadequate responses.

Solution: Prepare detailed, evidence-backed replies supported by technical and regulatory teams.

Expert Consultation and Support

With over 25 years of experience and having supported 500+ companies with CDSCO registrations, our team offers:

• End-to-end license application management
• Document preparation assistance including DMR, DHR, Risk Management Files
• Coordination with notified bodies and testing labs
• Training on compliance and post-market surveillance

Our proven track record ensures your micro-catheter reaches the Indian market in compliance with all regulatory mandates.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your micro-catheter’s Class C status using official CDSCO guidelines.
2. Prepare Required Documentation: Begin compiling company and device-specific files as outlined above.
3. Apply for Test License (MD13): Submit application via the CDSCO MD Online Portal to initiate product testing.
4. Coordinate Product Testing: Engage with approved laboratories early to avoid delays.
5. Plan for Audit: Align your manufacturing facility and QMS for the upcoming CDSCO inspection.
6. Submit MD9 License Application: Once testing and documentation are complete, file your MD9 application through the portal.
7. Engage Expert Support: Consider partnering with seasoned regulatory consultants to navigate complexities efficiently.

By following these precise steps and leveraging expert advice, your pathway to regulatory compliance for micro-catheters in India can be streamlined and successful. For deeper insights, refer to our detailed MD9 License Guide.

For personalized assistance and tailored solutions, connect with our regulatory experts who understand the nuances of CDSCO licensing for high-risk Class C devices like micro-catheters. Our dedicated support ensures your compliance journey is as smooth as possible, enabling you to focus on innovation and market growth.