CDSCO License for Evoked-potential audiometer

Introduction to Evoked-Potential Audiometer and Regulatory Importance

The Evoked-Potential Audiometer is a specialized electroacoustic device used in the ENT category to assess auditory brainstem responses (ABR) by evaluating the brain’s auditory pathway activity in response to acoustic signals. Given its clinical significance in diagnosing auditory neuropathies and other hearing impairments, regulatory compliance for this device is critical to ensure patient safety and device efficacy.

At our consultancy, with over 25 years of experience assisting 500+ medical device manufacturers and importers, we understand that obtaining the appropriate CDSCO license is a vital step to legally market your Evoked-Potential Audiometer in India. This device falls under Risk Class B as per the CDSCO classification, requiring adherence to specific licensing procedures governed by the State Licensing Authority.

CDSCO Regulatory Framework for Evoked-Potential Audiometer

The Central Drugs Standard Control Organization (CDSCO) classifies medical devices into four risk classes: A, B, C, and D. The Evoked-Potential Audiometer, being Class B, is considered a low moderate risk device. The relevant notification for this device is 29/Misc/03/2020-DC(196) dated 06.08.2021, which officially lists the device under CDSCO's regulated medical device list.

Compliance with this regulation ensures your device meets the essential principles of safety and performance laid out by CDSCO, enabling you to market the product confidently across Indian healthcare facilities.

Risk Classification and License Requirements for Class B Devices

Class B devices like the Evoked-Potential Audiometer require an MD5 manufacturing license issued by the respective State Licensing Authority. The process includes several stages:

• Obtaining a Test License (Form MD13)
• Product testing in CDSCO-approved laboratories
• Documentation and application submission (Form MD3)
• Audit by a notified body
• Resolution of queries
• Final license grant (Form MD5)

Manufacturers must comply with quality management and safety standards and demonstrate product conformity through testing and audits.

Manufacturing License Process (MD5) for Evoked-Potential Audiometer

The MD5 license process typically spans 3 to 4 months and involves the following practical steps:

1. Apply for Test License (MD13): This is the initial step to legally manufacture the device for testing purposes. It takes approximately 1.5 to 2 months.

2. Product Testing: Conduct product testing at government-approved testing laboratories to obtain necessary test reports. See the list of CDSCO-approved testing laboratories for your device.

3. Documentation Preparation: Compile essential documents including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.

4. Apply for Manufacturing License (Form MD3): Submit your application through the CDSCO MD Online Portal.

5. Notified Body Audit: An audit is conducted by an accredited notified body to assess compliance. Refer to the list of notified bodies.

6. Resolve Queries: Address any queries from the authorities or notified body promptly.

7. License Grant: Upon successful audit and compliance, the MD5 license (Form MD5) is issued.

Manufacturing License Documents Required for Evoked-Potential Audiometer

To streamline your application, prepare the following documents meticulously:

• Company Constitution (Registration Certificates)
• Proof of Ownership or Lease of Manufacturing Premises
• Qualification and Experience Certificates of Technical Staff
• Fire Safety NOC
• Pollution Control NOC
• Device Master File (DMF): Detailed design and manufacturing information (Guide here)
• Plant Master File (PMF): Details of manufacturing site and processes (Guide here)
• Essential Principles Compliance Checklist
• Risk Management File (Learn more about risk management)
• Test Reports from approved labs
• Product Labels and Instructions For Use (IFU)
• Quality Management System (QMS) Documents (preferably ISO 13485 certified)

Ensure all documents are accurate, complete, and aligned with CDSCO requirements to avoid delays.

Import License Process (MD15) for Evoked-Potential Audiometer

For importers wishing to bring the Evoked-Potential Audiometer into India, an MD15 import license is mandatory, granted by the Central Licensing Authority. The process generally takes 5 to 6 months and involves:

• Document preparation including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485, CE Certificate, Device and Plant Master Files
• Submission of application via CDSCO MD Online Portal
• Resolution of any departmental queries
• License issuance (Form MD15)

Unlike manufacturing, the import license process does not require a test license but demands rigorous documentation.

Import License Documents Required

Importers must submit:

• Foreign Manufacturing License
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate or equivalent
• Device Master File
• Plant Master File
• Wholesale License for distribution
• Company Constitution

Ensure these documents are up-to-date and authenticated for seamless processing.

Timeline and Processing Duration

Planning your project timeline with these durations in mind can help avoid costly delays.

Government Fees and Costs

For your Class B Evoked-Potential Audiometer, the fees are as follows:

• MD5 Manufacturing License:

  • Application Fee: Rs. 5,000
  • Per Product Fee: Rs. 500

• MD13 Test License:

  • Included within manufacturing fee structure but requires separate application

• MD15 Import License:

  • Site Fee: USD 2,000
  • Per Product Fee: USD 1,000

These fees are payable online via the CDSCO portal during application submission.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

Solution: Schedule testing early with government-approved labs and ensure sample readiness. Reference the Testing Laboratories list for accredited facilities.

Challenge 2: Documentation Gaps

Solution: Use our comprehensive checklists and templates for Device Master File and Plant Master File to avoid common omissions. Our Device Master File Guide is a valuable resource.

Challenge 3: Audit Non-Compliance

Solution: Conduct internal audits and gap assessments prior to notified body audits. Engage experienced consultants for audit readiness.

Challenge 4: Query Resolution Delays

Solution: Respond promptly and thoroughly to CDSCO or notified body queries to maintain application momentum.

Expert Consultation and Support

With over 25 years of deep regulatory expertise, we have successfully guided 500+ companies through the CDSCO licensing maze. Our hands-on support includes:

• Tailored document preparation and review
• Scheduling and liaison with notified bodies and testing labs
• Audit readiness and mock inspections
• End-to-end application management on the CDSCO MD Online Portal

Our proven processes minimize rejections and expedite approvals, saving you time and cost.

Getting Started with Your CDSCO License Application for Evoked-Potential Audiometer

Begin your journey by:

1. Classifying your device: Confirm your Evoked-Potential Audiometer as Class B via Medical Device Classification.

2. Register on the CDSCO portal: Create your organizational profile at the CDSCO MD Online Portal.

3. Prepare documentation: Assemble your Device Master File, Plant Master File, Risk Management File, and other statutory documents.

4. Apply for Test License: Initiate your application for Form MD13 to begin manufacturing for testing.

5. Plan product testing: Coordinate with CDSCO-approved labs early in the process.

6. Engage a notified body: Schedule your audit promptly after test reports are available.

7. Submit final application (Form MD3): Complete and submit your MD5 application with all supporting documents.

Starting early and partnering with experienced consultants can significantly smooth your licensing process. Contact us today to leverage our expertise and successfully bring your Evoked-Potential Audiometer to the Indian market.