CDSCO License for Enteral tube extension, non-sterile
Medical Device Information
Intended Use
A non-sterile, thin, flexible tube intended for extracorporeal connection to an enteral feeding tube (e.g., nasogastric tube) to increase the length of tubing from the patient to an oral/enteral device (e.g., syringe) during enteral feeding/medication administration or aspiration.
Comprehensive Guide to CDSCO Licensing for Enteral Tube Extension, Non-Sterile (Class B Medical Device)
As seasoned regulatory consultants with over 25 years of expertise and having supported more than 500 companies in obtaining CDSCO licenses, we understand the critical nuances involved in navigating India's medical device regulatory landscape. This guide provides a detailed walkthrough for manufacturers and importers of the Enteral Tube Extension, Non-Sterile, classified as a Class B device under the CDSCO framework. The device serves a vital role in gastroenterology by extending enteral feeding tubes, ensuring safe and effective nutrition or medication administration.
Understanding the Device and Its Regulatory Importance
The Enteral Tube Extension is a thin, flexible, non-sterile tube designed for extracorporeal connection to enteral feeding tubes such as nasogastric tubes. Despite being non-sterile, it directly interfaces with feeding systems, which places it in Class B according to CDSCO’s risk classification. Compliance with regulatory standards is mandatory to ensure patient safety and market access in India.
CDSCO Regulatory Framework for Enteral Tube Extension
Medical devices in India are regulated by the Central Drugs Standard Control Organization (CDSCO) under the Medical Device Rules, 2017. Since the Enteral Tube Extension is classified as Class B, it falls under the jurisdiction of State Licensing Authorities for manufacturing licenses, specifically governed by the MD5 license process. The regulatory landscape demands strict adherence to quality, safety, and documentation requirements before market authorization.
Risk Classification and License Requirements
- Device Risk Class: Class B (Low-Moderate Risk)
- License Type: Manufacturing License - MD5 (Application Form MD3)
- Regulatory Authority: State Licensing Authority
- Process Duration: Approximately 3-4 months (including test license, testing, audit, and license issuance)
To verify risk classification for your device and ensure proper compliance, consult the detailed Medical Device Classification guide.
Manufacturing License Process for Enteral Tube Extension (MD5 License)
- Test License Application (Form MD13): Initiate by applying for a test license, which typically takes 1.5 to 2 months to be granted by the State Licensing Authority.
- Product Testing: Conduct mandatory tests at CDSCO-approved laboratories. You can find a comprehensive list of Testing Laboratories here.
- Document Preparation: Compile all technical and quality documentation, including Device Master File, Plant Master File, Risk Management File, and others.
- Manufacturing License Application (Form MD3): Submit the application through the CDSCO MD Online Portal.
- Audit by Notified Body: Engage with a notified body for a manufacturing site audit. Refer to the official Notified Bodies List to select an authorized auditor.
- Queries and Clarifications: Address any queries or deficiencies raised by the licensing authority or notified body promptly.
- License Grant (Form MD5): Upon successful compliance, the State Licensing Authority grants the MD5 manufacturing license.
Manufacturing License Documents Required
For the Enteral Tube Extension (Class B), the following documents must be meticulously prepared and submitted:
- Company Constitution Proof: Registration certificates, Memorandum of Association.
- Proof of Premises Ownership or Lease: Valid property documents.
- Technical Staff Qualification and Experience Records: Details of competent technical personnel.
- Fire NOC and Pollution Control NOC: From relevant local authorities.
- Device Master File (DMF): Detailed device design, specifications, and manufacturing process; our Device Master File guide offers invaluable insights.
- Plant Master File (PMF): Documentation of manufacturing facilities and processes; refer to our Plant Master File guide.
- Essential Principles Checklist: Compliance with Indian Medical Device Rules essential principles.
- Risk Management File: Documented risk analysis and mitigation strategies; learn more about Risk Management.
- Test Reports: From CDSCO-approved testing laboratories.
- Labels and Instructions for Use (IFU): As per regulatory standards.
- Quality Management System (QMS) Documents: Typically ISO 13485 certification and related SOPs.
Import License Process for Enteral Tube Extension (MD15 License)
If you plan to import the Enteral Tube Extension into India, the process requires a central licensing authority-issued MD15 license. This process usually spans 5-6 months and includes:
- Preparation of all relevant documents such as Manufacturing License of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device and Plant Master Files.
- Submission of the application via the CDSCO MD Online Portal.
- Resolution of any queries raised by CDSCO.
- No test license is required for import licensing.
For detailed guidance, visit our Import License Guide.
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 3 – 4 weeks |
| Document Preparation | 2 – 3 weeks |
| Manufacturing License (MD5) | 1.5 – 2 months |
| Total Estimated Time | 3 – 4 months |
Government Fees and Costs
- Test License Fee: Included in MD5 application process.
- MD5 License Fees: Rs. 5,000 per application plus Rs. 500 per product.
- Additional Costs: Testing laboratory fees (~Rs. 50,000 - Rs. 1,00,000 depending on tests), notified body audit fees (varies by auditor).
Budgeting for unforeseen queries or additional document requests is prudent to avoid delays.
Common Challenges and Solutions
- Delays in Testing: Selecting the right CDSCO-approved lab early can prevent bottlenecks. Utilize the Testing Laboratories list to find capable labs.
- Incomplete Documentation: Engage experts for document preparation. Our detailed checklists ensure nothing is overlooked.
- Audit Non-Compliance: Thorough internal audits before notified body inspections can mitigate non-compliance risks.
- Query Management: Prompt and comprehensive responses to CDSCO queries are vital. Maintain clear communication channels.
Expert Consultation and Support
Navigating CDSCO licensing can be complex, especially for Class B devices like the Enteral Tube Extension. We offer tailored consultancy services, leveraging our extensive experience to streamline your licensing journey. From document preparation to audit readiness and query resolution, our hands-on approach minimizes risks and accelerates approvals.
Getting Started with Your CDSCO MD5 License Application
- Assess Risk Classification: Confirm your device is Class B using the Medical Device Classification resource.
- Initiate Test License Application: Submit Form MD13 via the CDSCO MD Online Portal.
- Schedule Product Testing: Engage a CDSCO-accredited lab early to avoid delays.
- Compile Documentation: Prepare your Device Master File, Plant Master File, Risk Management, and QMS documents.
- Plan for Audit: Contact a notified body from the official Notified Bodies List to schedule your site inspection.
- Submit Manufacturing License Application: Complete and file Form MD3 on the CDSCO portal.
- Respond to Queries Promptly: Address any regulatory or auditor concerns swiftly to maintain timelines.
By following these targeted steps and leveraging expert insights, manufacturers and importers can confidently navigate the CDSCO licensing process for the Enteral Tube Extension and successfully enter the Indian medical device market.
For personalized assistance and comprehensive support throughout your regulatory journey, feel free to reach out to our team of experts with 25+ years of proven success in CDSCO licensing.
