CDSCO License for Gustometer

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

As seasoned regulatory consultants with over 25 years of experience and having successfully assisted 500+ medical device companies, we understand the intricacies of navigating India’s Central Drugs Standard Control Organisation (CDSCO) licensing process. This guide focuses on the Gustometer, a Class B ENT device designed to deliver galvanic stimulus to elicit taste sensations. Whether you are a manufacturer or importer, this detailed walkthrough will help you secure your CDSCO license efficiently with minimal delays.

Understanding the Gustometer and Its Regulatory Importance

A Gustometer is a battery-operated medical device featuring two electrodes intended to provide galvanic stimulation to evoke taste sensations. Classified under the ENT category, it holds a Class B risk classification as per CDSCO’s medical device rules. Given its direct interaction with patient sensory pathways, regulatory oversight ensures safety, efficacy, and quality compliance before market authorization.

Compliance with CDSCO regulations is mandatory to legally manufacture or import this device in India. The notification 29/Misc/03/2020-DC(196) dated 06.08.2021 officially lists the Gustometer, confirming its classification and regulatory pathway.

CDSCO Regulatory Framework for Gustometer (Class B ENT Device)

The Gustometer falls under Class B devices, which are considered low to moderate risk. The licensing is governed by:

• The Medical Device Rules, 2017
• CDSCO guidelines for Class B device manufacture and import

The MD5 license is applicable for manufacturing Class B devices in India, granted by the State Licensing Authority.

For import, the MD15 license is required from the Central Licensing Authority.

Risk Classification and License Requirements

• Device Risk Class: B (Low to moderate risk)
• Applicable License: MD5 for manufacturing
• Regulatory Authority: State Licensing Authority (for MD5)
• Applicable Forms:
  • Test License: Form MD13 (mandatory first step)
  • Manufacturing License: Form MD3 (for MD5 license application)

Step-by-Step Manufacturing License Process (MD5 License)

1. Obtain Test License (Form MD13):

   • Duration: 1.5 to 2 months
   • Purpose: To allow product testing in government-approved labs

2. Product Testing:

   • Conduct testing at CDSCO-approved laboratories for conformity
   • Testing labs list can be found on the CDSCO Testing Laboratories page

3. Documentation Preparation:

   • Compile all technical and quality documents
   • Prepare Device Master File (DMF) and Plant Master File (PMF)
   • Refer to our comprehensive Device Master File guide and Plant Master File guide

4. Apply for MD5 License (Form MD3):

   • Submit online via the CDSCO MD Online Portal

5. Audit by Notified Body:

   • State authority appoints a notified body for manufacturing site audit
   • Check the list of notified bodies for audit requirements

6. Queries and Clarifications:

   • Respond promptly to any queries raised by CDSCO or notified bodies

7. Grant of License:

   • Upon satisfactory compliance, the State Licensing Authority issues the MD5 license in Form MD5

Manufacturing License Documents Required for Gustometer

• Company constitution documents (e.g., MOA, AOA)
• Proof of ownership or valid lease agreement of manufacturing premises
• Qualification and experience certificates of technical staff
• Fire safety NOC
• Pollution control NOC
• Device Master File (DMF) detailing design, specifications, and manufacturing processes
• Plant Master File (PMF) describing facility and equipment
• Essential Principles Checklist confirming compliance with Indian regulations
• Risk Management File specific to the Gustometer’s galvanic stimulation functionality
  • We recommend reviewing our risk management best practices
• Test reports from CDSCO-approved labs
• Device labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485:2016 certified

Import License Process (MD15 License) for Gustometer

If you plan to import the Gustometer, the following process applies:

1. Document Preparation:

   • 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
   • Company constitution documents

2. Application Submission:

   • Complete Form MD14 for the MD15 license application
   • Submit via the CDSCO MD Online Portal

3. Queries and Clarifications:

   • Address any CDSCO queries diligently

4. License Grant:

   • After review, CDSCO issues the MD15 import license

Timeline and Processing Duration

For import license (MD15), expect approximately 5 to 6 months from application to grant.

Government Fees and Costs

• MD5 Manufacturing License:

  • Application fee: Rs 5,000
  • Per product fee: Rs 500

• MD15 Import License:

  • Class B device fees:
    • Site fee: $2,000
    • Per product fee: $1,000

Additional costs include testing fees at government-approved labs, audit fees charged by notified bodies, and consultancy fees if you engage experts.

Common Challenges and Practical Solutions

• Delayed Testing Results: Plan testing early and select accredited labs from the official CDSCO list to avoid delays.
• Incomplete Documentation: Use detailed checklists and professional templates for DMF, PMF, and risk files.
• Audit Non-Compliance: Conduct internal mock audits before notified body inspections to ensure readiness.
• Query Resolution Delays: Assign a dedicated regulatory liaison to promptly address CDSCO queries.

Expert Consultation and Support

With our extensive experience assisting over 500 companies, we offer:

• Personalized gap analysis for your documentation
• End-to-end application preparation and submission
• Coordination with notified bodies and testing labs
• Training for your technical and regulatory teams

Our goal is to reduce your time-to-market and ensure smooth compliance.

Getting Started with Your CDSCO License Application for Gustometer

1. Assess your current documentation: Ensure your device design, risk management, and QMS are robust.
2. Register on the CDSCO MD Online Portal: Create an account and familiarize yourself with the interface.
3. Initiate Test License Application (MD13): This is mandatory before manufacturing license submission.
4. Schedule product testing at CDSCO-approved labs: Early testing prevents bottlenecks.
5. Prepare your Device and Plant Master Files: Use our detailed guides to streamline this process.
6. Engage with notified bodies early: Understand audit expectations specific to your state.
7. Submit MD5 license application (Form MD3): After successful testing and documentation.

By following these steps methodically and leveraging expert guidance, you can confidently navigate the CDSCO licensing pathway and bring your Gustometer to the Indian market with compliance and quality assurance.

For detailed assistance or to begin your application process, contact us today and benefit from our proven expertise in CDSCO medical device licensing.