CDSCO License for Tracheal (Endotracheal) Tube

Comprehensive Guide to CDSCO Licensing for Tracheal (Endotracheal) Tubes – Class B Medical Device

Tracheal (Endotracheal) Tubes, classified under Catheters and notified by CDSCO Notification 29/Misc/3/2017-DC (292) dated 06.06.2018, play a critical role in airway management by being inserted with the help of a laryngoscope to secure the trachea below the vocal cords. Given their vital function, these devices fall under Risk Class B as per India's medical device regulatory framework, necessitating a thorough and compliant licensing procedure before manufacturing or importing into India.

With over 25 years of expertise and having supported 500+ companies through the CDSCO licensing journey, we understand the nuances and complexities involved. This detailed guide provides you with actionable insights, timelines, costs, and documentation essentials to successfully obtain your CDSCO manufacturing or import license for Tracheal Tubes.

CDSCO Regulatory Framework for Tracheal (Endotracheal) Tubes

Under the Medical Device Rules, 2017, enforced by the Central Drugs Standard Control Organization (CDSCO), Tracheal Tubes are regulated as Class B devices due to their moderate risk profile. Compliance ensures patient safety, quality assurance, and market access in India.

Manufacturers require an MD5 manufacturing license issued by the State Licensing Authority, while importers must obtain an MD15 import license from the Central Licensing Authority.

Compliance with essential principles, quality management systems (ISO 13485), and adherence to labeling and packaging norms are mandatory.

Risk Classification and License Requirements for Tracheal Tubes

• Risk Class: B (Moderate risk)
• Applicable License for Manufacturing: MD5 License (Form MD3)
• Applicable License for Import: MD15 License (Form MD14)

As a Class B device, the regulatory path is streamlined compared to higher-risk classes but still requires rigorous documentation, product testing, and audit compliance.

Manufacturing License Process for Tracheal (Endotracheal) Tubes (MD5 License)

1. Test License Application (Form MD13):

   • Mandatory initial step to obtain a test license before manufacturing.
   • Processing time: Approximately 1.5 to 2 months.

2. Product Testing:

   • Conduct tests at CDSCO-approved government laboratories. Refer to the Testing Laboratories list for authorized facilities.
   • Testing includes biocompatibility, sterilization validation, dimensional verification, and mechanical integrity.

3. Document Preparation:

   • Prepare all required documents, including Device Master File (DMF), Plant Master File (PMF), and Risk Management File.

4. Application Submission:

   • Submit the manufacturing license application using Form MD3 via the CDSCO MD Online Portal.

5. Audit by Notified Body:

   • Engage with a notified body listed here for a manufacturing site audit.

6. Query Resolution:

   • Address any queries raised during document review or audit promptly.

7. License Grant:

   • Upon satisfactory review and audit, the State Licensing Authority issues the MD5 manufacturing license.

Manufacturing License Documents Required for Tracheal Tubes

• Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and Qualification Certificates of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF): Comprehensive technical documentation covering design, specifications, and validation. Our Device Master File guide is an excellent resource.
• Plant Master File (PMF): Details of manufacturing processes, quality control, and equipment. Learn more from our Plant Master File guide.
• Essential Principles Compliance Checklist
• Risk Management File aligned with ISO 14971 standards
• Test Reports from approved laboratories
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents (ISO 13485 certification is highly recommended)

Import License Process for Tracheal (Endotracheal) Tubes (MD15 License)

1. Document Preparation:

   • Gather all required documents, including manufacturing license from the country of origin, ISO 13485, CE certificates, and Free Sale Certificate.

2. Application Submission:

   • File the import license application on the CDSCO MD Online Portal using Form MD14.

3. Query Resolution:

   • Respond to any departmental queries efficiently to avoid delays.

4. License Grant:

   • The Central Licensing Authority processes and issues the MD15 import license.

Import License Documents Required for Tracheal Tubes

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Quality Management System Certificate
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License
• Company Constitution documents

Timeline and Processing Duration

Timely coordination with notified bodies, laboratories, and prompt response to CDSCO queries can help avoid unnecessary delays.

Government Fees and Costs

• MD5 License Fees:

  • Rs 5,000 per application
  • Rs 500 per product

• MD15 Import License Fees (Class B Device):

  • Rs 2,000 per site
  • Rs 1,000 per product

Additional costs include testing fees at government laboratories, audit charges by notified bodies, and consultancy fees if applicable.

Common Challenges and Solutions

• Challenge: Delays in product testing due to lab backlogs.

  • Solution: Schedule tests early and select labs with available capacity from the approved list.

• Challenge: Incomplete or inconsistent documentation.

  • Solution: Use comprehensive checklists and templates, such as those outlined in our DMF and PMF guides, to ensure thorough submissions.

• Challenge: Non-compliance during audits.

  • Solution: Conduct internal pre-audits and training sessions for staff to prepare for notified body inspections.

• Challenge: Navigating the CDSCO online portal.

  • Solution: Leverage expert consultancy or detailed user manuals to ensure proper application submission.

Expert Consultation and Support

Our seasoned team has successfully guided over 500 manufacturers and importers through the CDSCO licensing process for Class B devices like Tracheal Tubes. We offer:

• End-to-end regulatory strategy development
• Document preparation and review services
• Coordination with notified bodies and testing labs
• Application filing and query management
• Training on regulatory compliance and quality management

Partnering with experienced consultants can significantly reduce approval timelines and enhance compliance confidence.

Getting Started with Your CDSCO License Application for Tracheal Tubes

1. Assess Your Device Classification: Confirm your device’s Class B status, referencing the official Medical Device Classification resource.

2. Plan Product Testing: Contact a CDSCO-approved laboratory early to understand testing requirements and book slots.

3. Prepare Documentation: Begin compiling your Device Master File and Plant Master File using our practical guides.

4. Apply for Test License (if manufacturing): File Form MD13 on the CDSCO MD Online Portal.

5. Engage a Notified Body: For audits, select a notified body from the official list and schedule your inspection.

6. Submit Manufacturing or Import License Application: Use Form MD3 for manufacturing or Form MD14 for import licenses on the portal.

7. Respond Promptly to Queries: Maintain readiness to provide clarifications to expedite approval.

Starting the process with clear timelines and thorough preparation ensures a smoother regulatory journey and faster market entry for your Tracheal (Endotracheal) Tubes in India.

For detailed assistance and personalized regulatory solutions, contact our expert team today and leverage our 25+ years of CDSCO licensing experience to your advantage.