CDSCO License for Endotracheal tube introducer

Comprehensive Guide to CDSCO Licensing for Endotracheal Tube Introducer (Class A Medical Device)

As a trusted regulatory consultancy with over 25 years of experience and a track record of assisting 500+ companies, we understand the critical importance of securing timely and compliant CDSCO licenses for medical devices like the Endotracheal Tube Introducer. This essential respiratory device facilitates the safe insertion of endotracheal tubes during patient intubation and is classified as a Class A medical device under Indian regulations.

CDSCO Regulatory Framework for Endotracheal Tube Introducer

The Central Drugs Standard Control Organization (CDSCO) governs the import and manufacture of medical devices in India, ensuring safety, efficacy, and quality. The Endotracheal Tube Introducer falls within the scope of the Medical Device Rules (MDR) 2017 and subsequent amendments, notified under File No. 29/Misc/03/2020-DC(197) dated 6.8.2021.

Risk Classification and License Requirements for Class A Devices

Under CDSCO regulations, the Endotracheal Tube Introducer is a Class A device, representing low risk to patients. For manufacturers, this requires obtaining an MD5 manufacturing license from the State Licensing Authority. For importers, an MD15 import license from the Central Licensing Authority is mandatory.

Understanding these classifications is vital—you can verify device classification and stay updated via our Medical Device Classification resource.

Manufacturing License Process (MD5) for Endotracheal Tube Introducer

The MD5 license process for Class A devices is designed to be straightforward yet thorough, ensuring compliance with quality and safety norms. Here is the typical stepwise process:

1. Apply for Test License (Form MD13): Initially, you must secure a test license to manufacture the device samples. This takes approximately 1.5 to 2 months.

2. Product Testing: Samples must be tested in government-approved laboratories to verify compliance with relevant standards. Refer to the list of CDSCO-approved testing labs for authorized facilities.

3. Document Preparation: Prepare comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, and Quality Management System documents.

4. Application Submission (Form MD3): Submit your MD5 manufacturing license application through the CDSCO MD Online Portal.

5. Audit by Notified Body: A notified body conducts an on-site audit of your manufacturing facility and quality systems. You can select an auditor from the list of notified bodies.

6. Query Resolution: Address any queries or deficiencies highlighted by the CDSCO or notified body promptly.

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

This entire process typically spans 3 to 4 months from test license application to receiving the manufacturing license.

Manufacturing License Documents Required

For the Endotracheal Tube Introducer MD5 license application, prepare the following documents meticulously:

• Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of Ownership or Lease of Manufacturing Premises
• Details of Technical Staff (qualification certificates and experience)
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF): Detailed device specifications, design, sterilization, packaging, and labeling. Our Device Master File guide provides comprehensive insights.
• Plant Master File (PMF): Overview of manufacturing facility, processes, equipment, and quality controls. Learn how to create a robust PMF here.
• Essential Principles Compliance Checklist
• Risk Management File (including hazard analysis and mitigation strategies). Implement effective risk management with our Risk Management resource.
• Test Reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485 certification strongly recommended)

Import License Process (MD15) for Endotracheal Tube Introducer

If importing the Endotracheal Tube Introducer into India, you must obtain an MD15 import license granted by the Central Licensing Authority. The import process is as follows:

1. Document Preparation: Collate manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, DMF, PMF, wholesale license, and company constitution.

2. Application Submission (Form MD14): Submit the import license application via the CDSCO MD Online Portal.

3. Query Resolution: Respond to any queries raised by CDSCO.

4. Grant of License (Form MD15): Upon satisfaction, the license is issued.

This process generally takes 5 to 6 months.

Import License Documents Required

• Valid Manufacturing License of the product from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License for distribution in India
• Company Constitution Documents

Timeline and Processing Duration

Government Fees and Costs

For the Endotracheal Tube Introducer (Class A device):

• MD5 Manufacturing License:

  • Application Fee: ₹5,000
  • Per Product Fee: ₹500

• MD15 Import License:

  • Site Fee: $1,000 (approx ₹75,000)
  • Per Product Fee: $50 (approx ₹3,750)

Costs for product testing, audits, and consultancy services vary based on scope but budget accordingly.

Common Challenges and Solutions

• Incomplete Documentation: Many applicants underestimate the detail required in DMF and PMF. We recommend early preparation using expert templates.

• Delays in Testing: Sample testing in government labs can be time-consuming; plan submissions early and consider parallel activities.

• Audit Non-Compliance: Not addressing quality management gaps leads to audit failures. Conduct internal pre-audits to identify weaknesses.

• Query Management: Prompt and comprehensive responses to CDSCO queries accelerate approvals.

Our hands-on assistance has helped numerous manufacturers navigate these challenges efficiently.

Expert Consultation and Support

Navigating CDSCO licensing is complex, especially for first-time applicants. Our expert team offers end-to-end support from document preparation to audit readiness, ensuring smooth approval. We stay updated with regulatory changes and leverage our network with notified bodies and testing labs to expedite your licensing.

Getting Started with Your CDSCO License Application

1. Assess Your Device: Confirm your Endotracheal Tube Introducer classification and regulatory requirements.

2. Prepare Documentation: Start compiling DMF, PMF, and QMS documents now.

3. Apply for Test License: Initiate your MD13 application on the CDSCO MD Online Portal.

4. Engage a Notified Body: Schedule your audit early by referring to the list of notified bodies.

5. Plan Testing and Labeling: Coordinate product testing with approved labs and finalize labels/IFU.

6. Submit Manufacturing License Application: Complete Form MD3 submission and follow up on queries.

By following this roadmap and leveraging our proven expertise, you can confidently and efficiently secure your CDSCO MD5 license for your Endotracheal Tube Introducer, enabling market access and regulatory compliance in India.