CDSCO License for Audiometer

Comprehensive Guide to CDSCO Licensing for Audiometer (Class B Medical Device)

As seasoned regulatory consultants with over 25 years of experience and having successfully assisted 500+ companies, we understand the critical importance of securing timely CDSCO licenses for medical devices like the Audiometer. This device, classified as Class B under the Indian medical device regulations, plays a vital role in ENT diagnostics by evaluating hearing capability through tone generation across the audible frequency range. Navigating the regulatory framework efficiently is essential for manufacturers and importers aiming to enter or expand in the Indian market.

CDSCO Regulatory Framework for Audiometers (Class B)

Audiometers fall under the ENT category and are regulated by the Central Drugs Standard Control Organization (CDSCO) as per the notification 29/Misc/03/2020-DC(196) dated 06.08.2021. Classified as Class B, they are considered moderate risk devices requiring a structured approval process including testing, documentation, audit, and licensing.

The regulatory pathway follows the Medical Devices Rules, 2017, mandating a manufacturing license known as the MD5 license (for Class A and B devices) issued by the State Licensing Authority. This ensures compliance with safety, quality, and performance standards.

Risk Classification and License Requirements for Audiometer

• Device: Audiometer
• Risk Class: B (Moderate risk)
• Regulatory License: MD5 Manufacturing License (Form MD3)
• Licensing Authority: State Licensing Authority
• Application Portal: CDSCO MD Online Portal

Understanding your device’s classification is crucial. Class B devices like Audiometers require a test license (MD13), product testing from CDSCO-approved labs, and audit by a notified body before the manufacturing license is granted.

Manufacturing License Process (MD5) for Audiometer

The MD5 license process is comprehensive but manageable with the right guidance. The entire process takes approximately 3-4 months and involves the following steps:

1. Test License Application (Form MD13): Apply for a test license to legally manufacture and test your Audiometer prototype. This step takes about 1.5-2 months.

2. Product Testing: Conduct mandatory product testing in government-approved laboratories to demonstrate compliance with applicable standards. Refer to the List of Testing Laboratories for authorized facilities.

3. Documentation Preparation: Compile and finalize your Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System documents.

4. Application for MD5 License (Form MD3): Submit your application through the CDSCO MD Online Portal, attaching all required documents.

5. Audit by Notified Body: A notified body will conduct an on-site audit to verify compliance. Check the List of Notified Bodies to select a suitable auditor.

6. Queries Resolution: Address any queries raised by CDSCO or the notified body promptly to avoid delays.

7. Grant of License: Upon successful audit and document approval, the MD5 license will be issued.

Manufacturing License Documents Required for Audiometer

For a Class B device like the Audiometer, prepare the following key documents:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF) – Detailed device specifications, design, and manufacturing process (Device Master File guide)
• Plant Master File (PMF) – Manufacturing facility details and quality control procedures (Plant Master File guide)
• Essential Principles Checklist – Demonstrating conformity to Indian regulations
• Risk Management File – Risk assessment and mitigation strategies (Risk Management)
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485:2016 compliance)

Import License Process (MD15) for Audiometer

If you are importing Audiometers into India, you must obtain an MD15 import license from the Central Licensing Authority through the CDSCO MD Online Portal. The process typically takes 5-6 months and involves:

• Document preparation including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device Master File, and Plant Master File.
• Submission of application on Form MD14.
• Resolution of any queries raised by CDSCO.
• Final grant of Import License (Form MD15).

Refer to our detailed Import License guide for in-depth procedural insights.

Import License Documents Required

• Valid Manufacturing License from Country of Origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate or Equivalent
• Device Master File and Plant Master File
• Wholesale License (if applicable)
• Company Constitution Documentation

Timeline and Processing Duration

Manufacturers should anticipate approximately 3 to 4 months from test license initiation to MD5 license grant for Audiometer production.

Government Fees and Costs

• Test License Application (MD13): Rs. 5,000 (approximate, varies by state)
• MD5 Manufacturing License Application: Rs. 5,000 per application plus Rs. 500 per product
• Product Testing Fees: Variable depending on testing laboratory and number of tests
• Audit Fees: Paid directly to notified body; varies by auditor

Budgeting for these fees upfront and maintaining clear communication with auditors and testing labs can minimize unexpected expenses.

Common Challenges and Solutions

Challenge: Delays in test license approval and product testing.

Solution: Initiate test license application early and pre-select CDSCO-approved testing labs to avoid bottlenecks.

Challenge: Incomplete documentation leading to audit queries.

Solution: Utilize comprehensive checklists and expert consultation to ensure all documents, especially Device and Plant Master Files, are thorough and compliant.

Challenge: Responding to audit and CDSCO queries.

Solution: Assign dedicated regulatory personnel or consultants to handle prompt and accurate responses, minimizing approval delays.

Expert Consultation and Support

With over two decades of expertise and having guided over 500 medical device firms, we provide end-to-end support—from initial classification to license grant. Our services include:

• Strategic regulatory planning
• Document preparation assistance
• Coordination with notified bodies and testing labs
• Query management with CDSCO authorities

Engaging expert consultants can streamline the licensing journey, reduce timelines, and ensure compliance.

Getting Started with Your CDSCO License Application for Audiometer

To initiate your CDSCO MD5 license application for Audiometer manufacturing:

1. Assess Classification: Confirm your device classification as Class B using the Medical Device Classification tool.

2. Prepare Documents: Start compiling your Device Master File, Plant Master File, Risk Management File, and Quality Management System documentation.

3. Apply for Test License: Submit your MD13 test license application via the CDSCO MD Online Portal.

4. Plan Product Testing: Coordinate with CDSCO-approved testing laboratories early for product compliance testing.

5. Select Notified Body: Choose a notified body for audit from the official list.

6. Submit MD5 Application: Upon testing completion, submit your MD5 license application (Form MD3) online.

7. Prepare for Audit: Ensure your facility and documents are audit-ready.

By following this structured approach, manufacturers can confidently approach CDSCO licensing for Audiometer devices, ensuring compliance, timely approvals, and successful market entry across India.

For personalized support and detailed guidance, contact us to leverage our extensive experience in medical device regulatory affairs.