CDSCO License for Nasoenteral tube

Comprehensive CDSCO Licensing Guide for Nasoenteral Tubes (Class B Medical Devices)

As seasoned regulatory consultants with over 25 years of experience and having successfully assisted 500+ companies, we understand the complexities involved in securing CDSCO licenses for medical devices. This guide focuses specifically on Nasoenteral Tubes, a Class B sterile gastroenterology device designed for accessing the small intestines via the nasal route for diagnostic or therapeutic purposes.

Understanding the Nasoenteral Tube and Its Regulatory Importance

Nasoenteral tubes are critical in clinical settings for procedures such as intestinal decompression and short-term enteral feeding. Given its invasive use and patient safety considerations, CDSCO classifies it as a Class B medical device under the gastroenterology category, as per the notification 29/Misc./03/2020-DC (182), dated 27.09.2021.

Proper regulatory approval ensures compliance with Indian safety standards and allows manufacturers or importers to legally market these devices in India.

CDSCO Regulatory Framework for Nasoenteral Tubes

The Central Drugs Standard Control Organization (CDSCO) governs medical device licensing in India. For Class B devices like nasoenteral tubes, manufacturers must obtain the MD5 Manufacturing License, issued by the respective State Licensing Authority. This license confirms compliance with quality, safety, and efficacy standards.

Additionally, importers must secure an MD15 Import License from the Central Licensing Authority before bringing these devices into India.

Risk Classification and License Requirements for Nasoenteral Tubes

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

For detailed classification, manufacturers can refer to the Medical Device Classification guide.

Step-by-Step Manufacturing License Process (MD5) for Nasoenteral Tubes

The MD5 license process involves multiple stages spanning approximately 3-4 months:

1. Obtain a Test License (Form MD13) – This initial license permits testing of the device and takes about 1.5 to 2 months.
2. Product Testing – Conduct testing at CDSCO-approved government laboratories. A list of Testing Laboratories can be accessed for this purpose.
3. Document Preparation – Compile all necessary documentation including technical, quality, and safety files.
4. Application Submission – Submit the Form MD3 application via the CDSCO MD Online Portal.
5. Audit by Notified Body – The state authority arranges for an audit conducted by notified bodies listed here.
6. Respond to Queries – Address any observations or queries raised by the licensing authority or notified body.
7. Grant of License – Upon satisfactory compliance, the MD5 license is granted, allowing the manufacturer to produce the device legally.

For further guidance, our MD5 License Guide provides an in-depth overview.

Key Documents Required for MD5 License Application

• Company Constitution Documents (e.g., Memorandum and Articles of Association)
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualification Documents
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) – Detailed device specifications; refer to our Device Master File guide.
• Plant Master File (PMF) – Information on manufacturing facility; see our Plant Master File guide.
• Essential Principles Checklist verifying compliance with Indian standards
• Risk Management File demonstrating hazard analysis and mitigation strategies (see Risk Management)
• Test Reports from CDSCO-approved labs
• Labeling and Instructions for Use (IFU)
• Quality Management System (QMS) Documentation (ISO 13485 certification is advantageous)

Import License Process (MD15) for Nasoenteral Tubes

Importers seeking to bring nasoenteral tubes into India must apply for the MD15 license through the Central Licensing Authority. This process typically takes 5-6 months and includes:

• Document Preparation
• Submission of Form MD14 on the CDSCO MD Online Portal
• Resolution of Departmental Queries
• License Grant on Form MD15

Unlike domestic manufacturing, no test license (MD13) is required for imports, but comprehensive documentation must be furnished.

Documents Required for MD15 Import License

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate or equivalent regulatory approval
• Device Master File
• Plant Master File
• Wholesale License (if applicable)
• Company Constitution Documents

Timeline and Processing Duration

Government Fees and Costs

• MD5 Manufacturing License:
  • Application Fee: Rs. 5,000 per application
  • Product Fee: Rs. 500 per product
• MD15 Import License:
  • Class B devices: Rs. 2,000 per site + Rs. 1,000 per product

These fees are payable online through the CDSCO portal during application submission.

Common Challenges and Practical Solutions

Challenge 1: Delays in Product Testing

• Solution: Pre-book slots at CDSCO-approved labs early and ensure complete test samples and documentation to avoid retests.

Challenge 2: Incomplete Documentation

• Solution: Use detailed checklists and expert guidance to compile the Device Master File, Plant Master File, and Risk Management files.

Challenge 3: Queries during Audit or Review

• Solution: Maintain open communication with the notified body and CDSCO officers; respond thoroughly and promptly to all observations.

Challenge 4: Navigating the Online Portal

• Solution: Familiarize yourself early with the CDSCO MD Online Portal interface and keep digital copies of all documents ready for upload.

Expert Consultation and Support

With our extensive track record assisting over 500 medical device companies, we provide end-to-end support—from document preparation and audit coordination to application submission and post-license compliance. Leveraging experienced consultants can significantly reduce processing times and minimize the risk of refusals.

Getting Started with Your CDSCO License Application for Nasoenteral Tubes

1. Assess Your Device Classification – Confirm your device falls under Class B as per CDSCO guidelines.
2. Prepare Your Quality and Technical Documentation – Begin compiling your Device Master File and Plant Master File using our guides.
3. Book Testing Slots at Approved Labs – Early testing helps avoid delays.
4. Apply for the Test License (MD13) – Submit via the CDSCO MD Online Portal.
5. Coordinate with Notified Bodies for Audit – Select from the official Notified Bodies List.
6. Submit MD5 Application (Form MD3) – Once testing and audits are complete.
7. Respond Promptly to Queries – Maintain clear communication for smooth approval.

For importers, focus on compiling comprehensive documentation and submit your MD15 application accordingly.

By following these actionable steps and leveraging our expertise, manufacturers and importers can confidently navigate the CDSCO licensing landscape and bring their nasoenteral tubes to the Indian market efficiently and compliantly.