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CDSCO License for ENT shaver system

Medical Device Information

Device Class
Class B

Intended Use

Intended to resect/debride soft and osseous (bone) tissue in the nasal cavity or ear region during ear/nose/throat (ENT) or plastic surgery procedures; including functional endoscopic sinus surgery (FESS).

Manufacturing License
MD5
Import License
MD15
CDSCO License for ENT shaver system

Introduction to ENT Shaver System and Its Regulatory Importance

The ENT shaver system is a specialized medical device designed to resect and debride soft and osseous tissue within the nasal cavity or ear region. It plays a critical role in ear, nose, and throat (ENT) surgeries, including functional endoscopic sinus surgery (FESS) and various plastic surgery procedures. Given its invasive nature and direct contact with sensitive anatomical sites, regulatory compliance is imperative to ensure patient safety and market access in India.

Navigating the Central Drugs Standard Control Organization (CDSCO) regulatory framework is essential for manufacturers and importers aiming to introduce an ENT shaver system into the Indian market. With the device classified as a Class B medical device under the CDSCO notification 29/Misc/03/2020-DC(196) dated 06.08.2021, specific licensing requirements apply.

CDSCO Regulatory Framework for ENT Shaver System

The CDSCO governs medical devices under the Medical Device Rules (MDR) 2017, which categorize devices into four risk classes: A, B, C, and D. The ENT shaver system, being a Class B device, requires a manufacturing license from the State Licensing Authority, specifically an MD5 license, for domestic production. For importers, an MD15 import license granted by the Central Licensing Authority is mandatory.

This regulatory framework ensures stringent oversight on design, manufacturing, testing, and post-market surveillance of devices like the ENT shaver system to uphold high safety and efficacy standards.

Risk Classification and License Requirements for ENT Shaver System

  • Risk Class: B (Low to moderate risk)
  • Applicable License for Manufacturing: MD5 License (Application Form MD3)
  • Applicable License for Import: MD15 License (Application Form MD14)

Class B devices such as the ENT shaver system require a comprehensive process involving testing, documentation, and audits before license approval.

Manufacturing License Process (MD5) for ENT Shaver System

Obtaining an MD5 license for manufacturing the ENT shaver system involves several sequential steps:

  1. Test License Application (Form MD13): Initiate with a test license application to allow production of limited units for testing purposes. This phase takes approximately 1.5 to 2 months.

  2. Product Testing: Samples must be tested at CDSCO-recognized laboratories to verify compliance with Indian standards. Refer to the list of approved testing laboratories for suitable facilities.

  3. Documentation Preparation: Prepare detailed technical documents, including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, and Risk Management Files.

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

  5. Audit by Notified Body: A CDSCO-approved notified body will conduct a thorough audit of your manufacturing site and quality management system. Check the list of notified bodies authorized for MD5 audits.

  6. Resolution of Queries: Address any queries or deficiencies raised by the CDSCO or notified body promptly.

  7. Grant of MD5 License: Upon satisfactory review and audit, the license is granted in Form MD5.

Manufacturing License Documents Required for ENT Shaver System

  • Company Constitution Documents (Incorporation Certificate, Memorandum & Articles of Association)
  • Proof of Ownership or Lease Agreement of Manufacturing Premises
  • Details and Qualifications of Technical Staff
  • Fire Safety NOC
  • Pollution Control Board NOC
  • Device Master File (DMF) detailing design, components, and manufacturing process. Our detailed Device Master File guide can assist you.
  • Plant Master File (PMF) describing manufacturing facilities, equipment, and quality systems. See our Plant Master File guide for best practices.
  • Essential Principles Checklist confirming compliance with MDR 2017
  • Risk Management File aligned with ISO 14971 standards and risk management best practices
  • Product Test Reports from CDSCO-approved labs
  • Product Labels and Instructions for Use (IFU)
  • Quality Management System (QMS) documentation, preferably ISO 13485:2016 certification

Import License Process (MD15) for ENT Shaver System

For importers of the ENT shaver system, the MD15 license must be obtained from the Central Licensing Authority. The process includes:

  1. Document Preparation: Compile required documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 Certificate, CE Certificate (if applicable), and technical files.

  2. Application Submission (Form MD14): Apply via the CDSCO MD Online Portal, attaching all relevant documents.

  3. Review and Query Resolution: Respond to any CDSCO queries or requests for additional information.

  4. Grant of MD15 License: Upon satisfactory review, the import license will be issued.

Notably, importers are not required to obtain a test license prior to application.

Import License Documents Required for ENT Shaver System

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

Timeline and Processing Duration

License TypeApproximate Timeline
Test License (MD13)1.5 to 2 months
Manufacturing License (MD5)3 to 4 months (including test license and audit)
Import License (MD15)5 to 6 months

From our experience of assisting 500+ companies, proactive preparation and timely response to queries are critical to staying within these timelines.

Government Fees and Costs for ENT Shaver System Licensing

  • MD5 Manufacturing License:

    • Application Fee: Rs. 5,000
    • Per Product Fee: Rs. 500
  • MD15 Import License:

    • For Class B devices: Rs. 2,000 per site
    • Rs. 1,000 per product

Additional costs include testing fees at government-approved laboratories and notified body audit charges.

Common Challenges and Solutions

Challenge: Delays in test report issuance

Solution: Engage with accredited laboratories early and ensure sample submissions comply with test protocols.

Challenge: Incomplete or inconsistent documentation

Solution: Use comprehensive checklists and templates for DMF, PMF, and risk management files. Our Device Master File guide provides practical templates.

Challenge: Audit non-compliance

Solution: Conduct internal audits against notified body criteria before the official audit. Training your quality team on CDSCO requirements is essential.

Expert Consultation and Support

With over 25 years of regulatory consulting experience and 500+ successful CDSCO license approvals, we provide end-to-end support tailored to ENT device manufacturers and importers. From documentation preparation, testing coordination, audit readiness, to post-approval compliance, our expert team ensures a streamlined licensing journey.

Getting Started with Your CDSCO License Application for ENT Shaver System

  1. Assess Classification: Confirm your device’s classification as Class B under the latest CDSCO notification.

  2. Initiate Test License Application: Submit Form MD13 for test license via the CDSCO MD Online Portal.

  3. Engage Testing Labs: Coordinate product testing with a CDSCO-approved lab early to avoid bottlenecks.

  4. Prepare Documentation: Develop your DMF, PMF, Risk Management File, and other required documents. Leverage our guides for accuracy and compliance.

  5. Schedule Notified Body Audit: Identify and appoint a notified body from the official list for MD5 audits.

  6. Submit MD5 Application: Complete and submit Form MD3 with all attachments.

  7. Respond to Queries Promptly: Maintain clear communication with CDSCO and auditors.

For importers, prepare all import-specific documents and apply for the MD15 license following similar steps, minus the test license.

By following these actionable steps and leveraging expert insights, manufacturers and importers of the ENT shaver system can confidently navigate the CDSCO licensing process, ensuring timely market entry and regulatory compliance in India.

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About the Author

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Tails Azimuth
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