CDSCO License for Feeding Tube

Comprehensive CDSCO License Guide for Feeding Tube (Class B Medical Device)

Feeding tubes serve a critical role in healthcare, providing nutrition directly to patients who cannot eat normally. As a catheter-type medical device classified under Class B by CDSCO, feeding tubes require a meticulously managed regulatory pathway to ensure safety, efficacy, and market access in India. With over 25 years of regulatory expertise and having assisted 500+ companies in obtaining CDSCO licenses, we provide this detailed guide to help manufacturers and importers navigate the licensing process efficiently.

CDSCO Regulatory Framework for Feeding Tubes

Feeding tubes fall under the notified category of catheters as per Notification 29/Misc/3/2017-DC (292) dated 06.06.2018. The Central Drugs Standard Control Organization (CDSCO) regulates these devices under the Medical Device Rules, 2017, ensuring all safety and quality standards are met before market authorization.

Given the Class B risk classification, the manufacturing license is granted by the State Licensing Authority via the MD5 license, while import licensing is handled by the Central Licensing Authority under MD15. Understanding this framework is crucial for compliance and timely approval.

Risk Classification and License Requirements for Feeding Tubes

Feeding tubes are categorized as Class B devices, indicating low to moderate risk. This classification informs the regulatory controls and documentation required.

• Manufacturing License: Requires an MD5 license (Application Form MD3) issued by the State Authority.
• Import License: Requires an MD15 license issued by the Central Authority.

For detailed information on medical device classification, manufacturers can refer to the Medical Device Classification guide.

Manufacturing License Process (MD5) for Feeding Tubes

The MD5 license process for Class B devices like feeding tubes typically spans 3-4 months and involves several key steps:

1. Test License Application (Form MD13): Initiate by applying for a test license, which takes about 1.5 to 2 months.
2. Product Testing: Conduct mandatory testing at CDSCO-approved laboratories to validate safety and efficacy. Access the list of testing laboratories for selection.
3. Documentation Preparation: Assemble comprehensive technical and quality documentation.
4. License Application (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal.
5. Audit by Notified Body: Undergo an audit by a notified body. Manufacturers can consult the Notified Bodies List for audit services.
6. Query Resolution: Address any queries raised by CDSCO or the audit body promptly.
7. License Issuance (Form MD5): Upon successful compliance, the license is granted.

Manufacturing License Documents Required for Feeding Tubes

Accurate and complete documentation is pivotal. The essentials include:

• Certificate of Incorporation and Company Constitution
• Proof of ownership or lease of manufacturing premises
• Technical staff qualifications and experience certificates
• Fire and Pollution NOCs
• Device Master File (DMF) detailing design, manufacturing process, and specifications (Device Master File Guide)
• Plant Master File (PMF) describing the manufacturing facility and quality controls (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with safety norms
• Risk Management File documenting hazard analysis and mitigation (Risk Management Guide)
• Test Reports from CDSCO-approved labs
• Labeling and Instructions for Use (IFU)
• Quality Management System (QMS) documentation aligned with ISO 13485

Import License Process (MD15) for Feeding Tubes

Importers of feeding tubes must obtain an MD15 import license from the Central Licensing Authority. The process generally takes 5-6 months and includes:

1. Documentation Preparation: Compile mandatory documents including existing manufacturing license, quality certificates, and product dossiers.
2. License Application (Form MD14): Submit application via the CDSCO MD Online Portal.
3. Query Resolution: Respond to any CDSCO queries.
4. License Grant (Form MD15): Receive import authorization.

Import License Documents Required

Key documents for feeding tube import licensing include:

• Valid Manufacturing License (MD5 or MD9) from the country of origin
• Free Sale Certificate
• ISO 13485:2016 certification
• CE Certificate (if applicable)
• Device and Plant Master Files
• Wholesale Drug License (if applicable)
• Company Constitution and details

Timeline and Processing Duration

Expect some variability depending on document completeness and response times.

Government Fees and Costs

For feeding tubes classified as Class B:

• MD5 Manufacturing License:

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

• MD15 Import License:

  • Site Fee: $2,000 (approx ₹1.5 lakh)
  • Per Product Fee: $1,000 (approx ₹75,000)

These fees are payable online via the CDSCO portal.

Common Challenges and Solutions

• Delays in Product Testing: Choosing approved and responsive laboratories mitigates testing delays. Regular follow-ups and pre-submission of samples help.
• Incomplete Documentation: Utilizing detailed checklists and expert consultants ensures document accuracy.
• Audit Non-Compliance: Conduct internal mock audits and gap analyses prior to notified body inspections.
• Query Resolution Delays: Prompt and comprehensive responses reduce back-and-forth.

By anticipating these pain points, manufacturers can streamline their approval.

Expert Consultation and Support

Navigating CDSCO licensing demands specialized knowledge. We have successfully supported over 500 companies in obtaining licenses for feeding tubes and similar devices. Our end-to-end services include:

• Preparing Device and Plant Master Files
• Conducting pre-audit readiness assessments
• Coordinating with notified bodies and testing labs
• Managing online application submissions and follow-ups

Partnering with experienced regulatory consultants reduces risk and accelerates market entry.

Getting Started with Your CDSCO License Application for Feeding Tubes

To commence your CDSCO licensing journey:

1. Register your organization on the CDSCO MD Online Portal.
2. Initiate a test license (Form MD13) application.
3. Begin compiling your Device Master File and Plant Master File using our comprehensive guides.
4. Engage with a notified body early to schedule audits.
5. Prepare your product samples for testing at approved laboratories.
6. Maintain open communication channels for timely query resolution.

With structured planning and expert assistance, you can secure your CDSCO MD5 license within 3-4 months and position your feeding tube device successfully in the Indian market.

For a detailed walkthrough or personalized consultancy, contact our regulatory experts who have decades of experience guiding medical device manufacturers through India's evolving regulatory landscape.