CDSCO License for Enteral tube extension, sterile

Comprehensive Guide to CDSCO Licensing for Enteral Tube Extension (Sterile) – Class B Medical Device

As a trusted regulatory consultancy with over 25 years of experience and having supported 500+ companies, we understand the nuances and critical requirements for obtaining CDSCO licenses in India. In this guide, we provide detailed, actionable insights specifically for manufacturers and importers of the Enteral Tube Extension, sterile, a Class B medical device under the gastroenterology category.

Introduction to Enteral Tube Extension and Regulatory Importance

Enteral tube extensions are sterile, flexible tubes used to extend enteral feeding tubes, facilitating safe medication and nutrition delivery. Given their direct patient contact and clinical application, regulatory compliance is essential to ensure safety, efficacy, and market access in India.

The Central Drugs Standard Control Organization (CDSCO) mandates licensing for manufacturing and import of such devices under its Medical Device Rules (MDR) 2017, enforced since 2020 as per Notification 29/Misc./03/2020-DC (182) dated 27.09.2021. Compliance is not optional; it is a legal imperative to gain market authorization.

CDSCO Regulatory Framework for Enteral Tube Extension (Sterile)

Your device falls under Class B (low-moderate risk), making it subject to specific regulatory controls under the MDR 2017. The CDSCO framework requires:

• Test license application (Form MD13) for product testing
• Product testing at CDSCO-approved laboratories
• Submission of manufacturing license application (Form MD3 for MD5 License)
• Audit by a notified body
• Resolution of queries and final license grant

Understanding this pathway helps streamline compliance and reduces delays.

Risk Classification and License Requirements

• Device: Enteral Tube Extension (Sterile)
• Risk Class: B (as per MDR 2017 classification)
• Regulatory License: MD5 Manufacturing License (Form MD3)
• Licensing Authority: State Licensing Authority

For detailed classification criteria, you can refer to our Medical Device Classification guide.

Manufacturing License Process (MD5 License)

The MD5 license process for Class B devices involves several well-defined steps:

1. Apply for Test License (Form MD13): This allows you to legally manufacture and supply samples for mandatory testing.
2. Product Testing: Conducted at government-approved labs, testing the device against Indian standards.
3. Prepare Documentation: Device Master File, Plant Master File, Risk Management File, Quality Management System (QMS) documents, and others.
4. Submit Manufacturing License Application (Form MD3): Through the CDSCO MD Online Portal.
5. Audit by Notified Body: Select a notified body from the official Notified Bodies List for the inspection of your manufacturing site and QMS.
6. Address Queries: Promptly respond to any regulatory or audit queries.
7. Grant of License: Upon satisfaction, Form MD5 license is issued.

Manufacturing License Documents Required

For the Enteral Tube Extension, prepare the following:

• Company Constitution Documents (Incorporation certificate, partnership deed, etc.)
• Proof of Ownership/Lease of Manufacturing Premises
• Technical Staff Qualifications and Experience
• Fire NOC and Pollution NOC
• Device Master File (DMF): Detailed product specifications, design, manufacturing process (Device Master File guide)
• Plant Master File (PMF): Details of manufacturing facility and equipment (Plant Master File guide)
• Essential Principles Checklist: Compliance with Indian MDR essential principles
• Risk Management File: Hazard analysis, risk evaluation, and mitigation strategies (Risk Management guide)
• Test Reports: From CDSCO-approved testing laboratories (Testing Laboratories list)
• Labels and Instructions for Use (IFU): As per CDSCO labeling requirements
• Quality Management System Documents: ISO 13485 certification and internal SOPs

Import License Process (MD15 License)

If you are an importer rather than a manufacturer, applying for an MD15 license is necessary:

• Application Form: MD14
• Authority: Central Licensing Authority
• No Test License Required: Unlike manufacturing, product testing must be demonstrated via international certifications
• Documentation: Manufacturing license from country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, DMF, PMF, Wholesale license, and company incorporation documents
• Application Submission: Through CDSCO MD Online Portal

For detailed guidance, refer to our Import License guide.

Import License Documents Required

• Valid manufacturing license from the country of origin
• Free Sale Certificate (FSC) or Certificate of Market Authorization
• ISO 13485:2016 Certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale Drug License
• Company Constitution and Address Proof

Timeline and Processing Duration

Note: Timelines can vary based on document completeness and audit scheduling. Early preparation and expert support significantly reduce delays.

Government Fees and Costs

MD5 License (Class B Device):

• Application Fee: ₹5,000 per application
• Product Fee: ₹500 per product

Test License (MD13): Fees included in processing but subject to specific state rules.

MD15 Import License Fees:

• Class B: ₹2,000 per site
• ₹1,000 per product

Payments are made online via the CDSCO portal during application.

Common Challenges and Solutions

Challenge 1: Delays in product testing due to lab backlogs.

• Solution: Pre-schedule testing with CDSCO-approved labs and ensure sample compliance.

Challenge 2: Non-compliance in audit due to incomplete QMS or documentation.

• Solution: Conduct internal audits and mock inspections before notified body audits.

Challenge 3: Query resolution delays prolonging license issuance.

• Solution: Maintain open communication with CDSCO officers; submit clear, comprehensive responses promptly.

Challenge 4: Confusion over document requirements.

• Solution: Utilize detailed checklists and expert consultants to ensure completeness.

Expert Consultation and Support

With our extensive experience, we assist manufacturers and importers through every step—from initial classification, documentation, test license application, to audit support and final license grant. Our hands-on approach minimizes regulatory risks and accelerates time-to-market.

We also guide on post-license compliance, renewals, and regulatory updates to keep your product compliant throughout its lifecycle.

Getting Started with Your CDSCO License Application

1. Confirm Device Classification: Verify your device is Class B as per MDR using our classification resource.
2. Prepare Device and Plant Master Files: Develop detailed DMF and PMF documents.
3. Apply for Test License (MD13): Submit via the CDSCO MD Online Portal.
4. Coordinate Product Testing: Engage CDSCO-approved labs early to avoid bottlenecks.
5. Compile Complete Documentation: Follow the comprehensive checklist above.
6. Apply for MD5 License (Form MD3): Submit after test license and testing completion.
7. Schedule and Prepare for Audit: Choose your notified body from the official list and ready your facility.
8. Respond Promptly to Queries: Ensure swift communication with CDSCO officers.

By following these steps and leveraging expert support, you can confidently navigate the CDSCO licensing process for your Enteral Tube Extension device, ensuring compliance and successful market entry.

For personalized assistance and detailed process walkthrough, contact our regulatory experts today. Your compliance, our commitment.