CDSCO License for Enteral feeding tube clearing kit
Medical Device Information
Intended Use
A collection of non-sterile compounds and devices intended to be used to prevent and/or remove, through biochemical action, an enteral formula clog in an in situ enteral feeding tube to maintain luminal patency.
Comprehensive Guide to CDSCO Licensing for Enteral Feeding Tube Clearing Kits (Class B Medical Device)
With over 25 years of experience and having supported more than 500 companies in securing CDSCO licenses, we understand the nuances and regulatory intricacies involved in bringing medical devices like the Enteral Feeding Tube Clearing Kit to the Indian market. This device, classified as Class B under the Indian regulatory framework, demands stringent compliance to ensure safety and efficacy. Our comprehensive guide walks you through the entire process, from understanding the regulatory framework to obtaining the necessary manufacturing and import licenses.
Understanding the Enteral Feeding Tube Clearing Kit and Its Regulatory Significance
An Enteral Feeding Tube Clearing Kit is a specialized collection of non-sterile compounds and devices designed to prevent or remove clogs in enteral feeding tubes through biochemical action. Intended to maintain luminal patency, this device plays a critical role in gastroenterology care. Given its direct impact on patient safety and therapy continuity, regulatory oversight by the CDSCO (Central Drugs Standard Control Organization) is mandatory.
CDSCO Regulatory Framework for Enteral Feeding Tube Clearing Kits
The CDSCO regulates medical devices under the Medical Device Rules 2017 (amended). As a Class B device, the Enteral Feeding Tube Clearing Kit is subject to moderate risk classification, requiring manufacturers to obtain an MD5 manufacturing license issued by the State Licensing Authority. All applications and communication must be submitted through the CDSCO MD Online Portal, ensuring transparency and streamlining the licensing process.
Risk Classification and License Requirements
According to the notified classification under Notification 29/Misc./03/2020-DC (182) dated 27.09.2021, the Enteral Feeding Tube Clearing Kit falls under Class B. This classification necessitates the following:
- Manufacturing License: MD5 License (Form MD3)
- Test License: MD13 License (mandatory before manufacturing license application)
- Audit: Conducted by a notified body from the official list available on the CDSCO website
Manufacturing License Process (MD5) for Enteral Feeding Tube Clearing Kit
The manufacturing license process for a Class B device like the Enteral Feeding Tube Clearing Kit typically unfolds over 3-4 months and involves several critical steps:
Test License Application (Form MD13): This initial step allows you to manufacture the device for testing purposes. The test license usually takes 1.5 to 2 months to process.
Product Testing: Conduct compulsory testing at government-approved laboratories to validate device safety and performance. Refer to the list of testing laboratories for approved facilities.
Document Preparation: Compile comprehensive documentation, including the Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.
Application Submission (Form MD3): Submit the application for the manufacturing license through the CDSCO MD Online Portal.
Audit by Notified Body: An audit will be conducted by a notified body to assess compliance with manufacturing and quality standards.
Resolution of Queries: Address any queries raised by the department or notified body promptly to avoid delays.
Grant of License (Form MD5): Upon successful completion of all prior steps, the State Licensing Authority will grant the manufacturing license.
For a detailed walkthrough, our MD5 License Guide provides valuable insights.
Manufacturing License Documents Required
Preparing a robust application is crucial. For the Enteral Feeding Tube Clearing Kit, ensure you gather the following:
- Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
- Proof of Ownership or Lease of Manufacturing Premises
- Documents of Qualified Technical Staff (Qualifications and Experience)
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) detailing device specifications and manufacturing processes (Device Master File Guide)
- Plant Master File (PMF) describing manufacturing facilities and equipment (Plant Master File Guide)
- Essential Principles Compliance Checklist
- Risk Management File demonstrating risk analysis and mitigation strategies (Risk Management)
- Product Test Reports from Government-Approved Laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System Documents (ISO 13485:2016 preferred)
Import License Process (MD15) for Enteral Feeding Tube Clearing Kits
If you intend to import the Enteral Feeding Tube Clearing Kit into India, you must obtain an MD15 import license from the Central Licensing Authority. The process typically takes 5-6 months and includes:
Document Preparation: Assemble all relevant documents such as the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE certification, Device and Plant Master Files, Wholesale License, and Company Constitution.
Application Submission (Form MD14): File the application through the CDSCO MD Online Portal.
Query Resolution: Address any questions or clarifications sought by the CDSCO.
License Grant (Form MD15): Upon satisfying all requirements, the import license will be granted.
For further details, refer to our comprehensive Import License Guide.
Import License Documents Required
Key documents for import license applications include:
- Valid Manufacturing License from Country of Origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale License
- Company Constitution Documents
Timeline and Processing Duration
| License Type | Processing Time |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Manufacturing License (MD5) | 3 to 4 months (including audit) |
| Import License (MD15) | 5 to 6 months |
Planning ahead is essential to meet market entry timelines. Early submission of complete documentation and proactive query resolution can significantly reduce delays.
Government Fees and Costs
| License Type | Fee Structure |
|---|---|
| MD5 Manufacturing | Rs 5,000 per application + Rs 500 per product |
Additional costs include testing fees at approved laboratories and audit fees charged by notified bodies.
Common Challenges and Practical Solutions
Challenge: Delays due to incomplete documentation or non-compliance with audit requirements.
Solution: Engage experienced regulatory consultants to perform a pre-submission audit of your documentation and processes. This proactive approach minimizes the risk of rejection or queries.
Challenge: Difficulty in identifying suitable notified bodies and testing laboratories.
Solution: Use the official list of notified bodies and testing laboratories provided by CDSCO to select certified partners.
Challenge: Managing timelines effectively amidst other business priorities.
Solution: Establish a dedicated regulatory affairs team or partner with consultants specializing in CDSCO licensing to ensure timely follow-ups and compliance.
Expert Consultation and Support
Navigating the CDSCO regulatory landscape can be complex, especially for Class B devices like the Enteral Feeding Tube Clearing Kit. Our team offers tailored consultancy, document preparation assistance, audit readiness evaluation, and liaison services with regulatory authorities to streamline your licensing journey.
Getting Started with Your CDSCO License Application
To kickstart your CDSCO licensing process for the Enteral Feeding Tube Clearing Kit:
- Assess Device Classification: Confirm your device’s risk class and applicable license type.
- Prepare Documentation: Begin compiling comprehensive technical and quality documents as outlined.
- Apply for Test License: Submit your MD13 application through the CDSCO MD Online Portal.
- Schedule Testing: Coordinate with government-approved laboratories for product testing.
- Audit Preparation: Engage a notified body early for auditing and compliance guidance.
- Submit Manufacturing License Application: Once test reports and audit clearance are secured, file Form MD3 for the MD5 license.
By following these actionable steps and leveraging our expert support, you can confidently navigate the regulatory pathway and successfully launch your Enteral Feeding Tube Clearing Kit in India’s dynamic healthcare market.
