CDSCO License for Aneurysm clip.

Comprehensive Guide to CDSCO Licensing for Aneurysm Clips (Class D Neurological Devices)

Introduction: Understanding Aneurysm Clips and the Regulatory Landscape

Aneurysm clips are critical neurological devices designed to occlude intracranial aneurysms, effectively preventing potentially fatal bleeding or rupture. Given their high-risk nature (Class D under CDSCO classification), these devices require rigorous regulatory scrutiny before they can enter the Indian market.

Navigating the Central Drugs Standard Control Organization (CDSCO) licensing process is essential for manufacturers and importers aiming to ensure compliance, patient safety, and market access. With over 25 years of regulatory consulting experience and collaboration with 500+ companies, we provide you with a detailed roadmap tailored specifically for Class D devices like aneurysm clips.

CDSCO Regulatory Framework for Aneurysm Clips

The CDSCO regulates medical devices according to their risk classification under the Medical Device Rules, 2017. Aneurysm clips fall under Class D, the highest risk category, necessitating a license from the Central Licensing Authority. The relevant notification governing this device is 29/Misc/03/2020-DC (201) dated 27.09.2021.

Manufacturers and importers must obtain an MD9 license (Manufacturing License for Class C and D devices) to legally produce or market aneurysm clips in India.

Risk Classification and License Requirements

• Device Name: Aneurysm Clip
• Category: Neurological
• Risk Class: D (High Risk)
• License Type: MD9 (Application Form MD7)
• Licensing Authority: CDSCO Central Licensing Authority

Manufacturing License Process (MD9) for Aneurysm Clips

1. Test License (Form MD13): Before applying for the manufacturing license, obtain a test license which allows you to conduct testing and trials on the device. This takes approximately 1.5 to 2 months.

2. Product Testing: Get the aneurysm clip tested at CDSCO-approved laboratories. Check the list of testing laboratories to identify accredited facilities.

3. Document Preparation: Compile comprehensive documentation including technical files, Device Master File (DMF), Plant Master File (PMF), and other compliance materials.

4. Application Submission: Submit the manufacturing license application on Form MD7 via the CDSCO MD Online Portal.

5. Audit and Inspection: CDSCO inspectors conduct a detailed audit of your manufacturing facility, quality management system, and processes.

6. Query Resolution: Address any queries or deficiencies raised by the CDSCO or inspectors promptly.

7. Grant of License: Upon satisfactory compliance, the license is granted on Form MD9.

Manufacturing License Documents Required for Aneurysm Clips

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Details of Technical Staff and Their Qualifications
• Fire NOC and Pollution Control NOC
• Device Master File (DMF): Detailed device specifications, manufacturing process, and quality controls. Refer to our Device Master File guide for best practices.
• Plant Master File (PMF): Comprehensive documentation of the manufacturing site. Learn how to prepare a PMF here.
• Essential Principles Checklist
• Risk Management File aligned with ISO 14971 standards. Our Risk Management resource provides detailed insights.
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, preferably ISO 13485:2016 certification

Import License Process (MD15) for Aneurysm Clips

If you are an importer aiming to bring aneurysm clips into India, you must secure an import license (Form MD14) for Class D devices, granted by the Central Licensing Authority.

Steps include:

• Preparation of all required documents as specified under the import license section
• Submission of application on the CDSCO MD Online Portal
• Resolution of any queries raised by CDSCO reviewers
• Grant of Import License on Form MD15

Import License Documents Required

• Valid Manufacturing License of the device from the country of origin
• Free Sale Certificate demonstrating market authorization in the exporting country
• ISO 13485:2016 Certification
• CE Certificate or equivalent international approval
• Device Master File and Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution and Address Proof

Timeline and Processing Duration

• MD9 Manufacturing License: Approximately 4 to 5 months from test license application to final license grant.
• Test License (MD13): 1.5 to 2 months.
• Product Testing: Variable but generally 3 to 6 weeks depending on laboratory backlog.
• Import License (MD15): 5 to 6 months.

Government Fees and Costs

• MD9 License Fees: Rs 50,000 per application + Rs 1,000 per product.
• Test License Fees: Nominal fees as prescribed by CDSCO.
• Import License Fees:
  • Class D devices: Approx. $3,000 per site +$1,500 per product (USD equivalent in INR)

Expect additional costs related to product testing, document preparation, and potential consultancy fees.

Common Challenges and Solutions

• Delays in Testing: Testing at government labs can face backlogs. Proactively schedule testing and consider pre-submission consultations to minimize delays.
• Documentation Gaps: Incomplete or poorly prepared DMFs and PMFs often trigger queries. Use our comprehensive guides to ensure completeness.
• Audit Non-compliance: Facilities not fully aligned with ISO 13485 or CDSCO standards risk audit failures. Conduct internal audits and mock inspections beforehand.
• Query Management: Slow response to CDSCO queries can prolong approval. Establish a dedicated team for timely and accurate responses.

Expert Consultation and Support

With over 25 years of experience and successful licensing assistance to 500+ companies, we offer end-to-end support:

• Detailed gap analysis and document preparation
• Liaison with CDSCO and notified bodies
• Training on risk management and quality systems
• Mock audits and readiness assessments

Our clients benefit from streamlined processes, reduced timelines, and increased approval success rates.

Getting Started with Your CDSCO License Application for Aneurysm Clips

1. Assess Your Device Classification: Confirm risk class D under CDSCO regulations. You can cross-check using the Medical Device Classification resource.

2. Initiate Test License (MD13) Application: Prepare essential documents and submit through the CDSCO MD Online Portal.

3. Select Accredited Testing Laboratories: Identify labs from the official CDSCO list to conduct required product testing.

4. Develop Robust Technical Documentation: Compile DMF, PMF, Risk Management File, and QMS documents with expert help.

5. Schedule and Prepare for Audit: Coordinate with CDSCO inspectors and ensure full compliance.

6. Apply for MD9 License: Submit your application on Form MD7 after fulfilling all prerequisites.

7. Monitor Application Progress and Respond Promptly: Stay engaged with CDSCO queries to avoid delays.

Embarking on the CDSCO licensing journey for aneurysm clips can be complex, but with expert guidance and thorough preparation, your product can successfully reach Indian patients in need. Connect with our regulatory experts today to start your application with confidence and compliance.

For further detailed insights, refer to our specialized guides on MD9 License, Device Master Files, and Risk Management.