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CDSCO License for Coma-arousal vagus nerve electrical stimulation  system

Medical Device Information

Device Class
Class D

Intended Use

Intended to apply periodic stimuli to the vagus nerve for the purpose of exciting the patient to arousal from a vegetative state (i.e., a deep coma).

Manufacturing License
MD9
Import License
MD15
CDSCO License for Coma-arousal vagus nerve electrical stimulation  system

Introduction to Coma-Arousal Vagus Nerve Electrical Stimulation System and Regulatory Importance

The Coma-arousal vagus nerve electrical stimulation system is a sophisticated neurological medical device designed to apply periodic stimuli to the vagus nerve, aiming to excite patients from a vegetative state or deep coma. Given its critical therapeutic purpose and invasive nature, it falls under the highest risk classification—Class D—mandating the most stringent regulatory oversight in India.

At [our company], with over 25 years of experience and having assisted 500+ manufacturers and importers, we understand the complex regulatory landscape for such advanced devices. Securing a CDSCO license for Class D devices is not just a formality but a rigorous process that ensures patient safety while facilitating timely market entry.

CDSCO Regulatory Framework for Neurological Class D Devices

The Central Drugs Standard Control Organization (CDSCO) governs the import and manufacture of medical devices in India under the Ministry of Health and Family Welfare. Devices like the coma-arousal vagus nerve stimulator, categorized as Class D due to their high risk, require approval from the Central Licensing Authority (CLA).

The regulatory framework stipulates compliance with the Medical Device Rules, 2017, including conformity to Essential Principles of safety and performance, comprehensive documentation, and strict quality management systems.

Risk Classification and License Requirements for Coma-Arousal Vagus Nerve Stimulator

As per the Medical Device Classification, this neurological device is Class D, meaning it poses the highest risk to patients. Consequently, manufacturers must obtain an MD9 manufacturing license issued by the CDSCO central authority, while importers require an MD15 import license.

Manufacturing License Process (MD9) for Class D Neurological Devices

Obtaining an MD9 license involves multiple stages:

  1. Test License (Form MD13): Before applying for MD9, manufacturers must secure a test license to produce samples for testing. This typically takes 1.5 to 2 months.

  2. Product Testing: Samples must be tested at CDSCO-approved government laboratories to verify compliance with Indian standards. You can refer to the latest Testing Laboratories.

  3. Document Preparation: Comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist is prepared.

  4. License Application (Form MD7): Submit your MD9 application via the CDSCO MD Online Portal.

  5. Audit and Inspection: CDSCO conducts an onsite audit to verify compliance with Good Manufacturing Practices (GMP) and technical requirements.

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

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

For a Class D neurological device like yours, expect the entire process to span approximately 4 to 5 months.

Manufacturing License Documents Required for MD9 Application

Preparing a thorough and compliant dossier is crucial. For your device, the following documents are mandatory:

  • Company Constitution and Incorporation Documents
  • Proof of Ownership or Lease of Manufacturing Premises
  • Qualification and Experience Details of Technical Staff
  • Fire and Pollution No Objection Certificates (NOCs)
  • Device Master File (DMF) detailing device design, components, and performance (Device Master File Guide)
  • Plant Master File outlining manufacturing facilities and equipment (Plant Master File Guide)
  • Essential Principles Compliance Checklist
  • Risk Management File demonstrating hazard analysis and mitigation (Risk Management)
  • Test Reports from approved laboratories
  • Labeling and Instructions for Use (IFU)
  • Quality Management System Documents (ISO 13485:2016 certification recommended)

Import License Process (MD15) for Class D Neurological Devices

Importers of the Coma-arousal vagus nerve electrical stimulation system must obtain an MD15 license issued by the CDSCO Central Licensing Authority. Key steps include:

  1. Document Compilation: Gather all required documents including existing manufacturing license, ISO certificate, Free Sale Certificate from the country of origin, CE certificate if applicable, and device master and plant master files.

  2. Application Submission: Apply online through the CDSCO MD Online Portal.

  3. Review and Query Resolution: Respond to any CDSCO queries.

  4. License Issuance: The MD15 license is granted, typically within 5-6 months.

Import License Documents Required

The import license application for Class D devices requires:

  • Valid Manufacturing License (MD9) from the country of origin
  • Free Sale Certificate
  • ISO 13485:2016 Quality Management System Certificate
  • CE Certificate (if applicable)
  • Device Master File and Plant Master File
  • Wholesale Drug License (for distribution)
  • Company Constitution Documents

Timeline and Processing Duration

Process StageDuration
Test License (MD13)1.5 – 2 months
Product Testing1 – 1.5 months
Document Preparation1 month
MD9 License Application4 – 5 months
Import License (MD15)5 – 6 months

Total time to manufacture and import can range from 4 to 6 months depending on audit scheduling and query handling efficiency.

Government Fees and Costs

For your Class D device, the fee structure is as follows:

  • MD9 Manufacturing License: Rs. 50,000 per application + Rs. 1,000 per product
  • MD13 Test License: Included in the above process
  • MD15 Import License:
    • Site fee: $3,000 USD
    • Product fee: $1,500 USD per product

Additional costs may include testing fees at government labs and audit charges by notified bodies.

Common Challenges and Solutions

Challenge: Delays in test license approval and product testing.

Solution: Engage with notified bodies and CDSCO-approved labs early. Use our list of notified bodies to select the most responsive agencies.

Challenge: Incomplete or inconsistent documentation resulting in query backlog.

Solution: Prepare your Device Master File and Plant Master File meticulously, referencing our comprehensive guides linked above.

Challenge: Audit non-conformities due to gaps in QMS or facility compliance.

Solution: Implement ISO 13485:2016 and conduct internal audits before CDSCO inspection.

Expert Consultation and Support

Navigating CDSCO regulatory requirements for high-risk devices like the coma-arousal vagus nerve stimulator demands expertise. Our seasoned consultants provide end-to-end support—from initial classification and documentation to audit preparedness and license submission.

Leveraging our experience with over 500 successful CDSCO approvals, we help minimize delays and ensure compliance with evolving regulations.

Getting Started with Your CDSCO License Application

To embark on your licensing journey:

  1. Register your organization on the CDSCO MD Online Portal.
  2. Initiate the Test License (MD13) application to produce samples for testing.
  3. Identify and coordinate with CDSCO-approved testing laboratories early.
  4. Begin comprehensive documentation preparation, including Device Master File and Risk Management File.
  5. Schedule pre-audit internal reviews to ensure compliance.

By taking these practical steps, you position your coma-arousal vagus nerve electrical stimulation system for efficient CDSCO approval and successful entry into the Indian market.

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About the Author

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Tails Azimuth
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