CDSCO License for Cerebral perfusion  catheter

Comprehensive CDSCO Licensing for Cerebral Perfusion Catheters – A Class D Neurological Device

Cerebral perfusion catheters play a critical role in brain protection during profound hypothermic circulatory arrest in aortic surgeries. Classified under Class D by CDSCO, these high-risk neurological devices require stringent regulatory compliance before entering the Indian market. With over 25 years of experience and having successfully supported 500+ medical device companies, we provide a detailed roadmap for obtaining your CDSCO license efficiently and compliantly.

CDSCO Regulatory Framework for Cerebral Perfusion Catheters

The Central Drugs Standard Control Organization (CDSCO) governs the import and manufacture of medical devices in India. The cerebral perfusion catheter, notified under 29/Misc/03/2020-DC (201) dated 27.09.2021, falls under the highest risk class – Class D. This classification mandates approval from the Central Licensing Authority and adherence to rigorous testing, documentation, and quality management standards.

Risk Classification and License Requirements

• Device: Cerebral Perfusion Catheter
• Risk Class: D (High risk)
• Regulatory Pathway: MD9 License (Form MD7) for manufacturing; MD15 License for import

Class D devices require a central license due to their critical function and potential risk, with strict oversight including product testing, audits, and technical documentation review.

Manufacturing License Process (MD9) for Class D Devices

The manufacturing license for Class D devices is issued via the MD9 license process. Here’s a stepwise breakdown:

1. Test License Application (Form MD13): Before full manufacturing approval, a test license must be obtained to facilitate product testing. Timeline: 1.5 to 2 months.

2. Product Testing: Conduct mandatory product testing in CDSCO-recognized government-approved laboratories. Testing parameters cover biocompatibility, sterility, performance, and safety specific to cerebral perfusion catheters. Refer to the Testing Laboratories list for approved centers.

3. Document Preparation: Compile detailed technical documentation including Device Master File (DMF), Plant Master File (PMF), Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documents compliant with ISO 13485:2016 standards.

4. License Application (Form MD7): Submit your manufacturing license application via the CDSCO MD Online Portal with complete documents.

5. CDSCO Inspection & Audit: CDSCO officials conduct a thorough audit of manufacturing facilities and quality systems.

6. Query Resolution: Address any queries raised by the CDSCO or audit team promptly to avoid delays.

7. License Grant (Form MD9): Upon satisfactory review, the MD9 manufacturing license is granted.

Manufacturing License Documents Required

For cerebral perfusion catheters, you will need:

• Company Constitution and Incorporation documents
• Proof of ownership or lease of manufacturing premises
• Details of technical staff qualifications and experience
• Fire NOC and Pollution Control Board NOC
• Device Master File (comprehensive device description, design, manufacturing process) – See our Device Master File guide
• Plant Master File detailing manufacturing environment and controls – Learn more in our Plant Master File guide
• Essential Principles Checklist demonstrating compliance with Indian regulatory requirements
• Risk Management File outlining identified hazards and mitigation strategies – Explore Risk Management
• Test Reports from CDSCO-approved labs
• Product labels and Instructions for Use (IFU)
• Quality Management System documentation, including process validation, CAPA, and complaint handling

Import License Process (MD15) for Cerebral Perfusion Catheters

If you are importing cerebral perfusion catheters into India, the MD15 import license from the Central Licensing Authority is mandatory. The process includes:

1. Document Compilation: Prepare documents including existing manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device and Plant Master Files, Wholesale License, and Company Constitution.

2. Application Submission: Submit Form MD14 for MD15 license via the CDSCO MD Online Portal.

3. Review & Queries: The CDSCO reviews documents and may raise queries.

4. License Grant: Upon clearance, MD15 license is issued.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate confirming market availability elsewhere
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale Drug License
• Company constitution and address proof

Timeline and Processing Duration

For import licenses (MD15), the timeline is generally 5 to 6 months due to comprehensive document verification.

Government Fees and Costs

• MD9 Manufacturing License

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

• MD13 Test License

  • Included in manufacturing fees; no separate government fee but laboratory testing costs apply.

• MD15 Import License (Class D)

  • Application Fee: $3,000 per site
  • Per Product Fee: $1,500 per product

Additional costs include laboratory testing fees and expenses related to preparing detailed technical files and audits.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

• Solution: Engage early with CDSCO-recognized testing labs and pre-validate your samples to avoid retesting. Refer to the official Testing Laboratories list.

Challenge 2: Incomplete Technical Documentation

• Solution: Utilize comprehensive templates for Device and Plant Master Files and conduct internal audits to ensure compliance with Essential Principles and Risk Management requirements.

Challenge 3: Audit Non-compliance

• Solution: Prepare your facility based on notified audit requirements. While Class D audits are conducted by CDSCO inspectors, understanding notified body expectations (see Notified Bodies List) can help prepare beyond the minimum.

Challenge 4: Query Resolution Delays

• Solution: Maintain a dedicated regulatory team or consultant to promptly respond to CDSCO queries with complete supporting evidence.

Expert Consultation and Support

Navigating CDSCO licensing for Class D cerebral perfusion catheters is complex. With our extensive experience in successfully obtaining over 500 CDSCO licenses, we provide end-to-end support including:

• Gap analysis of your current compliance status
• Preparation of high-quality Device and Plant Master Files
• Coordination with CDSCO-approved testing labs
• Application submission and audit readiness
• Efficient query management to expedite approval

Our expert consultants ensure your path to market is as smooth and timely as possible.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification Confirm the risk classification as Class D for cerebral perfusion catheters.

2. Gather Documentation Early Begin compiling comprehensive documentation including company incorporation, technical files, and quality certifications.

3. Apply for Test License (MD13) Submit your application through the CDSCO MD Online Portal to initiate the test license process.

4. Partner with Accredited Testing Labs Schedule product testing with government-approved labs to obtain reliable and timely test reports.

5. Prepare for Audit and Inspection Ensure your manufacturing site and QMS meet all regulatory requirements ahead of CDSCO inspection.

6. Submit Manufacturing License Application (MD9) Once testing and documentation are complete, apply for your MD9 manufacturing license.

7. Respond to Queries Promptly Address any CDSCO or audit-related inquiries quickly to avoid unnecessary delays.

8. Plan for Post-Licensing Compliance Maintain ongoing compliance through vigilance, complaint handling, and periodic audits.

Embarking on your CDSCO licensing journey for cerebral perfusion catheters requires meticulous planning and expert guidance. Contact us to leverage our 25+ years of regulatory expertise and accelerate your market entry with confidence.

For detailed guidance on manufacturing licenses for Class C and D devices, refer to our MD9 License Guide. For import licensing insights, see our Import License Guide.

We are committed to helping you navigate India’s complex regulatory landscape with clarity and confidence.