CDSCO License for Enteral feeding kit, adult/paediatric, sterile

Comprehensive Guide to CDSCO Licensing for Enteral Feeding Kit (Adult/Pediatric, Sterile) – Class B Medical Device

As specialists with over 25 years of experience in medical device regulatory affairs, we have supported more than 500 companies in navigating the complex landscape of CDSCO licensing in India. This guide focuses on the enteral feeding kit (adult/paediatric, sterile), classified as a Class B medical device, designed for long-term nutrient administration via the gastrointestinal tract.

Introduction: Device Overview and Regulatory Importance

The enteral feeding kit is a critical device used in pediatric and adult care for patients requiring nutritional support. It consists of sterile tubing and components to deliver nutrient liquids directly into the stomach, duodenum, or jejunum, excluding infants. Given its invasive nature and long-term usage, stringent regulatory compliance is essential to ensure patient safety and product quality.

In India, the Central Drugs Standard Control Organization (CDSCO) governs the approval and licensing of such devices. Adhering to CDSCO regulations not only facilitates legal marketing but also establishes trust and credibility in the Indian healthcare market.

CDSCO Regulatory Framework for Enteral Feeding Kits

The regulatory framework for medical devices in India follows the Medical Device Rules (MDR) 2017, amended periodically. Enteral feeding kits fall under Class B, which is considered low to moderate risk. The manufacturing and import of Class B devices require obtaining a manufacturing license (MD5) or import license (MD15), respectively.

The licensing authority for manufacturing Class B devices is the State Licensing Authority, while import licenses are issued by the Central Licensing Authority.

Risk Classification and License Requirements

• Risk Class: B
• License Type: MD5 Manufacturing License (Application Form MD3)
• Authority: State Licensing Authority
• Test License Required: Yes, MD13 Test License prior to manufacturing license

Class B devices require a comprehensive audit and product testing to confirm compliance with applicable standards and essential principles.

Manufacturing License Process (MD5) for Enteral Feeding Kit

The manufacturing license process for Class B devices consists of several key stages:

1. Apply for Test License (Form MD13):

   • Duration: 1.5 to 2 months
   • Purpose: Obtain permission to manufacture the device for testing purposes

2. Product Testing:

   • Conducted at CDSCO-approved government testing laboratories
   • Testing validates safety, sterility, and performance
   • You can find the list of approved testing laboratories here

3. Documentation Preparation:

   • Prepare essential documents including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documentation

4. Submit Manufacturing License Application (Form MD3):

   • Submit via the CDSCO MD Online Portal

5. Audit by Notified Body:

   • Conducted by an independent body authorized by CDSCO
   • Refer to the list of notified bodies for audit

6. Query Resolution:

   • Respond promptly to any queries raised by the licensing authority or notified body

7. Grant of MD5 License:

   • Upon successful audit and document review

Manufacturing License Documents Required for Enteral Feeding Kit

The following documents are required for the MD5 license application:

• 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 No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) covering design, composition, and manufacturing processes (read our full Device Master File guide)
• Plant Master File (PMF) detailing manufacturing facilities and equipment (our PMF guide here)
• Essential Principles Checklist verifying compliance with applicable standards
• Risk Management File documenting hazard analysis and mitigation measures (learn about risk management)
• Test Reports from government approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485:2016 certified

Import License Process (MD15) for Enteral Feeding Kit

If you are an importer, obtaining an MD15 import license is mandatory for Class B devices.

Process Overview:

1. Document Preparation:

   • Ensure all import-specific documents are ready, including Free Sale Certificate, CE Certificate, and QMS certificates

2. Apply for Import License (Form MD14):

   • Submission via the CDSCO MD Online Portal

3. Query Resolution:

   • Address any departmental queries

4. License Grant (Form MD15):

Documents Required:

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

Timeline and Processing Duration

For import licenses (MD15), expect a timeline of approximately 5 to 6 months due to central authority processing.

Government Fees and Costs

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

Common Challenges and Solutions

• Delayed Test Reports: Plan testing early and choose CDSCO-approved labs with proven turnaround times.
• Incomplete Documentation: Use detailed checklists and templates, especially for Device and Plant Master Files.
• Audit Non-Compliance: Conduct pre-audit internal assessments and training for staff.
• Query Management: Assign dedicated personnel for timely and clear responses to CDSCO queries.

Expert Consultation and Support

With our extensive experience in securing over 500 CDSCO licenses, we offer tailored support:

• End-to-end application preparation
• Gap analysis of your existing QMS
• Assistance in compiling Device and Plant Master Files
• Coordination with notified bodies and testing labs
• Post-approval compliance support

Our clients benefit from reduced timelines and smoother approval processes, avoiding common pitfalls.

Getting Started with Your CDSCO License Application

1. Classify your device accurately: Confirm your device’s Class B status via the Medical Device Classification guide.

2. Register on the CDSCO MD Online Portal: Create your user account to initiate applications.

3. Prepare your Device and Plant Master Files: Utilize expert templates and samples to ensure completeness.

4. Apply for the MD13 Test License: Submit early to allow testing and product validation.

5. Engage with a notified body: Schedule your audit in advance to align with your licensing timeline.

6. Compile and submit the MD5 application: Ensure all documents are verified and compliant.

By following these actionable steps, you set a strong foundation for a successful CDSCO license grant, enabling your enteral feeding kit to enter the Indian market confidently and compliantly.

For personalized assistance in your CDSCO licensing journey, contact us to leverage our 25+ years of regulatory expertise.