CDSCO License for Double Lumen for intestinal Decompression and/or Intubation Tube

Comprehensive Guide to CDSCO Licensing for Double Lumen Intestinal Decompression and Intubation Tubes

Introduction

The Double Lumen Intestinal Decompression and/or Intubation Tube is a critical medical device designed primarily for tracheal intubation. This flexible plastic catheter plays an essential role in maintaining an open airway or providing a conduit for drug administration, making it indispensable in clinical settings. Given its invasive nature and clinical importance, regulatory compliance is paramount for manufacturers and importers aiming to enter the Indian market.

At our consultancy, with over 25 years of experience and having supported 500+ companies in obtaining CDSCO licenses, we understand the intricacies involved in navigating the regulatory framework for such Class B devices. This guide offers practical, detailed insights into the licensing requirements, timelines, costs, and documentation tailored specifically for your Double Lumen device.

CDSCO Regulatory Framework for Double Lumen Catheters

The Central Drugs Standard Control Organization (CDSCO) governs the import and manufacture of medical devices in India. The Double Lumen for intestinal decompression falls under the catheter category, notified under Notification 29/Misc/3/2017-DC (292) dated 06.06.2018. This device is classified as Class B due to its moderate risk profile, involving contact with the body via natural orifice and requiring controlled manufacturing and quality oversight.

India’s regulatory framework mandates strict adherence to safety, quality, and performance standards, with licensing handled at the state or central level depending on the device’s risk class.

Risk Classification and License Requirements

According to CDSCO’s classification:

• Class A & B devices (Low to Low-Moderate Risk) require an MD5 manufacturing license issued by the State Licensing Authority.
• Class C & D devices (Higher risk) require an MD9 license from the Central Licensing Authority.

Since your Double Lumen device is Class B, the applicable license is MD5 (Form MD3 for application and Form MD5 for grant).

Manufacturing License Process (MD5)

The MD5 license process involves several critical steps:

1. Test License (Form MD13): Before applying for MD5, obtain a test license allowing you to manufacture the device for testing purposes. This takes approximately 1.5 to 2 months.

2. Product Testing: Conduct product testing at certified government-approved laboratories to generate mandatory test reports.

3. Document Preparation: Gather all technical and quality documentation, including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.

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

5. Audit by Notified Body: A notified body from the list of notified bodies will audit your manufacturing site and QMS.

6. Query Resolution: Address any queries raised by the licensing authority or notified body promptly.

7. Grant of License (Form MD5): Once all criteria are met, the manufacturing license is granted.

Manufacturing License Documents Required

Successful MD5 license application requires comprehensive documentation, including:

• Company Constitution and Registration Proof
• Proof of Premises Ownership or Lease Agreement
• Details and Qualifications of Technical Staff
• Fire Safety NOC
• Pollution Control NOC
• Device Master File (DMF) detailing design, materials, and manufacturing processes (Device Master File Guide)
• Plant Master File (PMF) describing the manufacturing environment (Plant Master File Guide)
• Essential Principles Checklist ensuring compliance with safety and performance
• Risk Management File per ISO 14971 principles (Risk Management)
• Test Reports from government-approved testing laboratories (Testing Laboratories)
• Device Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485:2016 certification recommended)

Import License Process (MD15)

For importers, the applicable license is the MD15 import license issued by the Central Licensing Authority. The process is as follows:

1. Document Preparation: Prepare all relevant documents including Manufacturing License, Free Sale Certificate from the country of origin, ISO 13485:2016, CE Certificate (if applicable), Device Master and Plant Master Files, Wholesale License, and Company Constitution.

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

3. Query Resolution: Respond to any departmental queries.

4. Grant of License (Form MD15): Upon successful review, the import license is granted.

Note: Unlike manufacturing licenses, no test license is needed before applying for import licenses.

Import License Documents Required

Key documents for MD15 include:

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate or equivalent
• Detailed Device Master File and Plant Master File
• Wholesale Drug License
• Company Constitution and Ownership Proof

Timeline and Processing Duration

• MD5 Manufacturing License (Class B):

  • Test License (MD13): 1.5 to 2 months
  • Product Testing: 3 to 4 weeks
  • Audit and Document Review: 1 to 1.5 months
  • Total Time: Approximately 3 to 4 months

• MD15 Import License:

  • Document Preparation: Varies
  • Application Review and Grant: 5 to 6 months

Government Fees and Costs

• MD5 License (Class B)

  • Application Fee: Rs 5000
  • Per Product Fee: Rs 500

• MD15 Import License (Class B)

  • Site Fee: Approximately $2000 per site
  • Per Product Fee: $1000 per product

Additional costs include test laboratory fees, notified body audit charges, and consultancy fees if applicable.

Common Challenges and Solutions

1. Delays in Test Laboratory Results: Ensure you select a government-approved testing lab from the official list and schedule testing early.

2. Incomplete Documentation: Utilize checklists and templates to prepare your Device Master File and Plant Master File meticulously. Our guides on Device Master Files and Plant Master Files offer step-by-step assistance.

3. Audit Non-Compliance: Conduct internal pre-audits and ensure your QMS aligns with ISO 13485 standards before the notified body visit.

4. Query Resolution Delays: Assign dedicated regulatory personnel to respond promptly and comprehensively to CDSCO queries.

Expert Consultation and Support

Navigating the regulatory landscape for Class B devices like the Double Lumen Intestinal Decompression Tube can be complex. Our seasoned regulatory consultants have guided over 500 companies through successful CDSCO approvals. We offer tailored support including:

• End-to-end application preparation
• Document drafting and review
• Coordination with notified bodies and testing labs
• Pre-audit readiness assessments
• Post-approval compliance assistance

Getting Started with Your CDSCO License Application

To initiate your licensing journey:

1. Classify your device accurately – Confirm risk class B status using the Medical Device Classification tool.

2. Register on the CDSCO MD Online Portal at https://cdscomdonline.gov.in/ and familiarize yourself with submission requirements.

3. Apply for the Test License (Form MD13) to begin manufacturing for testing.

4. Select a certified testing laboratory early to prevent bottlenecks.

5. Prepare your Device and Plant Master Files using expert templates to ensure compliance.

6. Plan and schedule your notified body audit after compiling all documents.

7. Maintain open communication with regulatory authorities to expedite query resolution.

By following these actionable steps and leveraging seasoned expertise, your company can successfully obtain the MD5 manufacturing license for the Double Lumen device and confidently enter the Indian medical device market.

For personalized guidance and comprehensive support, connect with our regulatory experts who bring 25+ years of experience and deep CDSCO knowledge to your project.