CDSCO License for Bare-metal intracranial  vascular stent

Regulatory Guide for Bare-metal Intracranial Vascular Stent (Class D Neurological Device) in India

Introduction: Understanding Your Device and Its Regulatory Importance

The bare-metal intracranial vascular stent is a high-risk Class D medical device designed for implantation into the base or parent artery of an intracranial aneurysm. Given its critical application in neurological interventions, it is subject to stringent regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) in India. Compliance with CDSCO regulations ensures patient safety, product efficacy, and smooth market entry. With over 25 years of experience and having assisted 500+ companies, we provide detailed guidance on navigating the complex licensing process for your device.

CDSCO Regulatory Framework for Bare-metal Intracranial Vascular Stents

As per the CDSCO notification 29/Misc/03/2020-DC (201) dated 27.09.2021, bare-metal intracranial vascular stents fall under the neurological category and are classified as Class D devices due to their high risk and invasive nature.

Class D devices require licensing from the Central Licensing Authority (CLA) under the CDSCO framework. This involves rigorous evaluation, including test licensing, product testing at approved laboratories, documentation review, and regulatory audits.

Risk Classification and License Requirements

• Risk Class: D (Highest risk category)
• License Type: MD9 Manufacturing License (Form MD7) for manufacturing
• Import License: MD15 License (Form MD14) from Central Licensing Authority for importers

This risk classification demands compliance with strict quality and safety standards due to the device’s critical implantation use.

Manufacturing License Process (MD9 License)

For manufacturing the bare-metal intracranial vascular stent in India, an MD9 license issued by the CDSCO Central Licensing Authority is mandatory. The process follows these key stages:

1. Test License Application (Form MD13): Obtain a test license to facilitate product testing. This step takes approximately 1.5 to 2 months.
2. Product Testing: Conduct testing at government-approved laboratories to verify safety and performance. Refer to the CDSCO list of testing laboratories for authorized labs.
3. Documentation Preparation: Compile comprehensive technical documentation, including Device Master File (DMF), Plant Master File (PMF), risk management files, and QMS documents.
4. License Application (Form MD7): Submit the MD9 license application through the CDSCO MD Online Portal with all requisite documents.
5. Regulatory Audit: Prepare for an on-site audit by CDSCO inspectors covering manufacturing premises, processes, and quality systems.
6. Query Resolution: Address any queries or observations raised by CDSCO or auditors promptly.
7. License Grant: Upon satisfactory compliance, the MD9 license is granted in Form MD9.

Manufacturing License Documents Required

To facilitate the MD9 license application, ensure you have the following documents ready:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease Agreement for Manufacturing Premises
• Details and Qualifications of Technical and Managerial Staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) – Refer to our comprehensive Device Master File guide
• Plant Master File (PMF) – Guidance available in our Plant Master File guide
• Essential Principles Compliance Checklist
• Risk Management File as per ISO 14971 standards – insights in our Risk Management guide
• Test Reports from CDSCO-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documentation, ideally ISO 13485:2016 certification

Import License Process (MD15 License)

For companies looking to import the bare-metal intracranial vascular stent into India, an MD15 import license from the CDSCO Central Licensing Authority is required. The import license process is as follows:

1. Document Preparation: Gather all technical and regulatory documents, including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files.
2. Application Submission: Apply for the MD15 license via the CDSCO MD Online Portal using Form MD14.
3. Evaluation and Queries: Respond promptly to any clarifications or additional information requests from CDSCO.
4. License Issuance: Upon successful review, the import license (Form MD15) is granted.

Import License Documents Required

• Valid Manufacturing License issued by the foreign regulatory authority
• Free Sale Certificate from the country of origin
• ISO 13485:2016 Certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution and ownership proof
• Product Labels and IFU

Timeline and Processing Duration

• MD9 Manufacturing License: Approximately 4 to 5 months total. This includes:

  • Test License (MD13): 1.5 to 2 months
  • Product Testing: 3 to 4 weeks
  • Documentation and Application Processing: 1 to 2 months
  • Regulatory Audit and Query Resolution: 1 month

• MD15 Import License: Approximately 5 to 6 months from application submission to license grant.

Government Fees and Costs

• MD9 Manufacturing License:

  • Application Fee: Rs. 50,000 per application
  • Product Fee: Rs. 1,000 per product

• MD15 Import License: Fees vary by device class; for Class D devices:

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

Additional costs include product testing fees, audit fees, and consultancy charges if applicable.

Common Challenges and Practical Solutions

• Delayed Test Reports: Coordinate early with government-approved labs to schedule testing and avoid bottlenecks.
• Incomplete Documentation: Use detailed checklists and professional templates for DMF and PMF to ensure completeness.
• Regulatory Queries: Maintain proactive communication with CDSCO and prepare clear, evidence-backed responses.
• Audit Preparedness: Conduct mock audits internally to identify gaps and improve compliance.

Expert Consultation and Support

Navigating CDSCO regulations for Class D devices like the bare-metal intracranial vascular stent can be complex. We leverage our 25+ years of experience to offer tailored consultancy, document preparation assistance, and liaison with regulatory authorities to streamline your licensing journey.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm Class D categorization and identify applicable regulations.
2. Prepare Initial Documentation: Start compiling your Device Master File, Plant Master File, and QMS documents.
3. Apply for Test License (MD13): Early application helps reduce overall timelines.
4. Coordinate Product Testing: Engage with CDSCO-approved testing labs listed on the Testing Laboratories page.
5. Submit Manufacturing License Application: Use the CDSCO MD Online Portal for electronic submission.
6. Plan for Audit: Schedule and prepare for the CDSCO inspection.

By following this structured approach, manufacturers and importers can efficiently obtain the necessary CDSCO licenses for bare-metal intracranial vascular stents, ensuring compliance and timely market access.

For detailed guidance on the MD9 license process, refer to our MD9 License Guide. For import procedures, visit our Import License Guide.