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CDSCO License for Esophagoscope, General & Plastic Surgery

Medical Device Information

Device Class
Class B

Intended Use

An endoscope used for visual examination, diagnosis, and treatment of the esophagus. The insertion section changes its shape corresponding to the shape of the body cavity. The device is inserted through the oral cavity.

Manufacturing License
MD5
Import License
MD15
CDSCO License for Esophagoscope, General & Plastic Surgery

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

Navigating the regulatory landscape for medical devices in India can be complex, especially for innovative devices like the Esophagoscope used in general and plastic surgery. With over 25 years of experience and having supported more than 500 companies, we provide you with an authoritative, step-by-step guide to securing your CDSCO license for this Class B device, ensuring compliance, efficiency, and market readiness.

Understanding the Esophagoscope and Its Regulatory Importance

The Esophagoscope is a sophisticated endoscopic device designed for the visual examination, diagnosis, and treatment of the esophagus. Its flexible insertion section adapts to body cavity shapes, enhancing patient safety and diagnostic accuracy. Given its direct patient contact and invasive use via the oral cavity, regulatory oversight is critical to ensure safety, efficacy, and quality.

CDSCO Regulatory Framework for Esophagoscope (Class B)

India's Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules, 2017. The Esophagoscope falls under the Dermatological & Plastic Surgery category with Risk Class B, as notified (Notification No. 29/Misc./03/2020-DC dated 26.7.2021).

For Class B devices, the manufacturing license comes under the MD5 License process, managed by the State Licensing Authority. This ensures that the device meets all quality and safety standards before entering the Indian market.

Risk Classification and License Requirements

  • Risk Class: B (Low-Moderate Risk)
  • Applicable License: MD5 Manufacturing License (Form MD3)
  • Authority: State Licensing Authority
  • Process Duration: Approximately 3-4 months (including test license and audit)

Manufacturing License Process for Esophagoscope

  1. Test License (Form MD13): Before applying for the manufacturing license, obtain a test license. This step typically takes 1.5 to 2 months.
  2. Product Testing: Conduct mandatory product testing at CDSCO-approved laboratories. Check the list of testing laboratories for authorized facilities.
  3. Document Preparation: Prepare essential documents such as Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS).
  4. License Application Submission: File the application on the CDSCO MD Online Portal using Form MD3.
  5. Notified Body Audit: A notified body will audit your manufacturing premises and documentation. Refer to the list of notified bodies for selecting an auditor.
  6. Queries Resolution: Address any queries raised by the department or notified body promptly.
  7. Grant of License: Upon successful audit and document verification, the license is granted on Form MD5.

Manufacturing License Documents Required

  • Company Constitution and Incorporation Certificates
  • Proof of Ownership or Lease of Manufacturing Premises
  • Qualifications and Experience of Technical Staff
  • Fire and Pollution NOCs
  • Device Master File detailing design, specifications, and intended use (Device Master File Guide)
  • Plant Master File describing manufacturing processes (Plant Master File Guide)
  • Essential Principles Checklist (compliance with safety and performance requirements)
  • Risk Management File outlining hazard analysis and control (Risk Management)
  • Test Reports from approved labs
  • Labels and Instructions for Use (IFU)
  • Quality Management System (e.g., ISO 13485:2016) documentation

Import License Process (Not applicable for manufacturers but essential for importers)

For importers of Esophagoscope, the MD15 license is mandatory. This is granted by the Central Licensing Authority and typically takes 5-6 months. The process involves document submission, scrutiny, and approval without a prior test license requirement.

Key documents include manufacturing license of the foreign manufacturer, Free Sale Certificate, ISO 13485 certification, CE certificate, Device and Plant Master Files, and wholesale license.

Detailed guidance is available in our Import License Guide.

Timeline and Processing Duration

Process StepDuration
Test License (MD13)1.5 to 2 months
Product Testing2 to 3 weeks
Document Preparation2 to 4 weeks
License Application and Audit1 to 1.5 months
Total Estimated Time3 to 4 months

Government Fees and Costs

  • Application Fee: Rs. 5,000 per application
  • Product Fee: Rs. 500 per product

For an Esophagoscope under Class B, expect the total fee to be approximately Rs. 5,500 for the initial license covering one product. Additional products will incur additional fees.

Common Challenges and Solutions

Challenge: Delays due to incomplete documentation or insufficient test data.

Solution: Rigorously follow the document checklist, engage with notified bodies early, and select CDSCO-approved testing labs.

Challenge: Audit non-compliance due to inadequate QMS or facility standards.

Solution: Implement ISO 13485:2016 QMS and pre-audit your facility with expert consultants.

Challenge: Prolonged query resolution.

Solution: Maintain clear communication with CDSCO officers and respond to queries comprehensively and promptly.

Expert Consultation and Support

With our extensive experience assisting over 500 medical device companies, we offer tailored consulting services that cover every step—from test license procurement to audit preparation and license application. Our insights help you avoid common pitfalls and expedite approvals.

Getting Started with Your CDSCO License Application

  1. Assess Your Device Classification: Confirm your Esophagoscope’s Class B status via the Medical Device Classification tool.
  2. Initiate Test License Application: Prepare and submit Form MD13 through the CDSCO MD Online Portal.
  3. Select a CDSCO-Approved Testing Laboratory: Arrange for product testing early.
  4. Compile Required Documentation: Utilize our Device Master File Guide and Plant Master File Guide for comprehensive document preparation.
  5. Plan for Notified Body Audit: Coordinate audit dates and prepare your facility accordingly.
  6. Submit Manufacturing License Application: Complete Form MD3 on the CDSCO portal.
  7. Monitor Application Progress: Stay responsive to queries and provide timely clarifications.

By following this structured approach and leveraging expert support, manufacturers and importers can streamline their regulatory journey and bring their Esophagoscope devices confidently to the Indian market.

For personalized assistance and detailed walkthroughs, contact our regulatory consultancy team experienced in CDSCO medical device licensing.


Note: All timelines and fees are subject to regulatory updates; always verify current norms on the official CDSCO MD Online Portal.

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About the Author

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Tails Azimuth
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