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CDSCO License for Auditory Brainstem Implant System

Medical Device Information

Device Class
Class D

Intended Use

An auditory brain stem implant is a small device that is surgically implanted in the brain of a deaf person whose auditory nerves is lacking or damaged.  The auditory nerves conduct the sound signals from the ear to the brain. The implant enables otherwise the deaf  people to have a sensation of hearing.

Manufacturing License
MD9
Import License
MD15
CDSCO License for Auditory Brainstem Implant System

Comprehensive Guide to CDSCO Licensing for Auditory Brainstem Implant Systems

Auditory Brainstem Implant Systems are critical internal prosthetic replacement devices designed to restore hearing sensations in deaf patients with damaged or absent auditory nerves. Given their complex nature and high-risk classification, obtaining the appropriate regulatory approval from the Central Drugs Standard Control Organization (CDSCO) is indispensable before marketing or manufacturing in India.

With over 25 years of experience and having supported more than 500 companies in navigating the Indian medical device regulatory landscape, we provide a detailed, practical roadmap specifically tailored for manufacturers and importers of this Class D device.

CDSCO Regulatory Framework for Auditory Brainstem Implant Systems

Auditory Brainstem Implant Systems fall under the category of internal prosthetic replacements, notified under CDSCO Notification No. 29/Misc/3/2017-DC (18) dated 16.08.2018. As a Class D medical device, they are subject to the most stringent regulatory controls due to their critical function and invasiveness.

The CDSCO operates under the Ministry of Health and Family Welfare and regulates medical devices through a risk-based classification system, ensuring patient safety and device efficacy.

Risk Classification and License Requirements

  • Device: Auditory Brainstem Implant System
  • Risk Class: D (Highest Risk)
  • License Type: MD9 Manufacturing License
  • Authority: Central Licensing Authority (CDSCO Headquarters, New Delhi)

Class D devices require a central license, rigorous testing, and audits due to their high-risk profile. This device’s invasive nature and critical function necessitate comprehensive documentation, testing, and quality management compliance.

Manufacturing License Process (MD9)

The MD9 license is mandatory for manufacturing Class C and D devices in India. The process involves several steps:

  1. Test License (Form MD13): Before applying for the MD9 license, manufacturers must obtain a Test License to produce and test the device prototype for safety and efficacy. This phase typically requires 1.5 to 2 months.

  2. Product Testing: Conduct product testing at CDSCO-approved government laboratories. Testing laboratories can be found on the CDSCO MD Online Portal.

  3. Document Preparation: Prepare comprehensive documentation, including Device Master File and Plant Master File.

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

  5. Audit by CDSCO Inspectors: A thorough audit of the manufacturing facility and quality systems is conducted.

  6. Query Resolution: Address any queries from CDSCO inspectors promptly.

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

The entire process from test license application to final MD9 license issuance generally takes 4 to 5 months.

Manufacturing License Documents Required

For the MD9 license application, the following documents are essential:

  • Company Constitution (Memorandum & Articles of Association)
  • Proof of ownership or lease of manufacturing premises
  • Qualification and experience details of technical staff
  • Fire No Objection Certificate (NOC)
  • Pollution Control Board NOC
  • Device Master File (DMF) detailing design, specifications, manufacturing processes (Device Master File Guide)
  • Plant Master File (PMF) covering infrastructure and equipment (Plant Master File Guide)
  • Essential Principles Checklist demonstrating compliance with Indian Medical Device Rules
  • Risk Management File outlining hazard analysis and mitigation (Risk Management)
  • Test Reports from CDSCO-approved labs
  • Labeling and Instructions for Use (IFU)
  • Quality Management System (QMS) documentation (ISO 13485:2016 certification is highly recommended)

Import License Process (MD15) for Auditory Brainstem Implant Systems

For importers, the MD15 license is mandatory and granted by the Central Licensing Authority. The process involves:

  • Document compilation including manufacturing license, Free Sale Certificate, ISO 13485 certification, CE Certificate, Device Master File, Plant Master File, Wholesale License, and Company Constitution.
  • Application submission on the CDSCO MD Online Portal.
  • Review and resolution of queries.
  • License issuance.

The MD15 license process for Class D devices typically takes 5 to 6 months.

Import License Documents Required

  • Valid Manufacturing License from the country of origin
  • Free Sale Certificate
  • ISO 13485:2016 certificate
  • CE Certificate or equivalent regulatory approval
  • Device Master File and Plant Master File
  • Wholesale drug license (if applicable)
  • Company Constitution

Timeline and Processing Duration

Process StepEstimated Duration
Test License (MD13)1.5 to 2 months
Product Testing1 to 1.5 months
Document Preparation2 to 3 weeks
MD9 License ApplicationSubmission to Grant: 2 to 3 months
Total Estimated Time4 to 5 months

For import license (MD15), the timeline is 5 to 6 months.

Government Fees and Costs

  • MD9 Manufacturing License:

    • Application Fee: Rs. 50,000 per application
    • Product Fee: Rs. 1,000 per product
  • Test License (MD13): Usually included as part of the process; nominal fees apply.

  • Import License (MD15):

    • Class D Devices: USD 3,000 per site
    • Product Fee: USD 1,500 per product

Manufacturers should also budget for testing, audit fees (if applicable), and consultancy charges if external support is engaged.

Common Challenges and Solutions

Challenge: Delays in audit scheduling and query resolutions.

Solution: Proactively prepare documentation and maintain open communication with CDSCO. Engage experienced regulatory consultants to ensure compliance and rapid response.

Challenge: Difficulty in obtaining comprehensive test reports from approved labs.

Solution: Prioritize early engagement with notified testing laboratories listed on the CDSCO portal to schedule testing slots.

Challenge: Complexity of risk management and quality system documentation.

Solution: Implement ISO 13485:2016-compliant QMS and follow standardized templates for risk management, leveraging expert guidance.

Expert Consultation and Support

Navigating the CDSCO licensing for Class D devices like the Auditory Brainstem Implant System requires meticulous attention to detail and regulatory expertise. Our seasoned consultants offer:

  • Comprehensive document preparation and review
  • Audit readiness training
  • Liaison with CDSCO authorities and notified bodies
  • Support for test license procurement and product testing

Our proven track record with over 500 successful licensing projects ensures that your application proceeds smoothly and efficiently.

Getting Started with Your CDSCO License Application

  1. Assess your device classification to confirm Class D status.
  2. Initiate documentation preparation: Start compiling your Device Master File and Plant Master File immediately.
  3. Apply for the Test License (Form MD13) via the CDSCO MD Online Portal.
  4. Schedule product testing with CDSCO-approved laboratories early to avoid delays.
  5. Prepare for the CDSCO audit by ensuring your QMS aligns with ISO 13485 and risk management protocols.
  6. Submit your MD9 license application (Form MD7) once testing and documentation are complete.
  7. Engage regulatory experts for query management and audit facilitation.

For importers, gathering all necessary foreign regulatory documents and ensuring compliance with Indian import requirements is paramount before applying for the MD15 license.

Starting early and maintaining a proactive approach significantly improves your chances of a timely and successful CDSCO license grant, enabling you to bring this life-changing auditory implant technology to Indian patients in need.

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About the Author

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Tails Azimuth
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