CDSCO License for NasoGastric Tube/ Ryles Tube
Medical Device Information
Intended Use
It is a special tube that carries food and medicine to the stomach through the nose. It can be used for all feedings or for giving a person extra calories.
Comprehensive Guide to CDSCO Licensing for NasoGastric Tube (Ryles Tube) – Class B Medical Device
NasoGastric tubes, commonly known as Ryles tubes, are critical medical devices designed to deliver nutrition and medication directly to the stomach via the nasal passage. Classified under Class B (low-moderate risk) medical devices and categorized as catheters, these tubes play an essential role in patient care, especially for those unable to ingest food orally. If you are a manufacturer or importer aiming to introduce NasoGastric tubes into the Indian market, navigating the CDSCO licensing process efficiently is crucial. With over 25 years of experience assisting 500+ companies in obtaining CDSCO approvals, we provide a detailed, step-by-step roadmap tailored to this device type.
CDSCO Regulatory Framework for NasoGastric Tubes (Class B Catheters)
The Central Drugs Standard Control Organization (CDSCO) governs the regulatory compliance of medical devices in India. Under the Medical Device Rules, 2017, NasoGastric tubes fall under Class B (low-moderate risk) and require a manufacturing license from the State Licensing Authority (MD5 license) and an import license (MD15) if imported.
The device is listed under notification number 29/Misc/3/2017-DC (292), dated 06.06.2018, which specifies its regulatory classification and associated compliance requirements.
Risk Classification and License Requirements for NasoGastric Tubes
- Risk Class: B
- License Type: MD5 Manufacturing License (Form MD3) for Indian manufacturers
- Import License: MD15 License (Form MD14) for importers
- Regulatory Authority: State Licensing Authority for MD5; Central Licensing Authority for MD15
Being a Class B device, the licensing process involves pre-market product testing, documentation audits, and facility inspections to ensure safety and quality.
Manufacturing License Process for NasoGastric Tube (MD5 License)
As a manufacturer, obtaining an MD5 license is mandatory before production and marketing. The process typically spans 3-4 months and involves several critical stages:
Test License Application (Form MD13): Obtain a test license to manufacture sample products for testing purposes. This takes approximately 1.5 to 2 months.
Product Testing: Get the NasoGastric tubes tested at a CDSCO-approved laboratory to demonstrate conformity with essential principles and standards. Refer to the CDSCO Testing Laboratories list.
Documentation Preparation: Prepare comprehensive technical documents including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.
License Application Submission: Submit your application on the CDSCO MD Online Portal using Form MD3.
Audit by Notified Body: A third-party audit by a notified body is mandatory. You can check the list of notified bodies authorized for Class B devices.
Query Resolution: Respond to any queries raised by the licensing authority or notified body promptly.
Grant of MD5 License: Once compliance is confirmed, the license is issued on Form MD5.
Manufacturing License Documents Required for NasoGastric Tube
- Company Constitution/Registration Documents
- Proof of Ownership or Lease of Manufacturing Premises
- List and Qualification Documents of Technical Staff
- 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 (Plant Master File guide)
- Essential Principles Compliance Checklist
- Risk Management File documenting hazard analysis and mitigations (Risk Management guide)
- Test Reports from CDSCO-approved labs
- Labeling and Instructions for Use (IFU) documents
- Quality Management System (QMS) documents such as ISO 13485 certifications
Import License Process for NasoGastric Tube (MD15 License)
Importers of NasoGastric tubes must secure an MD15 license issued by the Central Licensing Authority. This process usually takes 5-6 months and includes:
Document Preparation: Compile required documents including manufacturing and quality certifications.
License Application: Submit Form MD14 via the CDSCO MD Online Portal.
Query Resolution: Promptly address any clarifications sought by CDSCO.
License Grant: Upon satisfactory review, the MD15 import license is issued.
Importantly, unlike manufacturing licenses, a test license is not required for import.
Import License Documents Required for NasoGastric Tube
- Valid Manufacturing License from the country of origin
- Free Sale Certificate or Certificate of Export from the country of origin
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale Drug License (if applicable)
- Company Constitution and Address Proof
Timeline and Processing Duration
| License Type | Duration | Notes |
|---|---|---|
| Test License (MD13) | 1.5 to 2 months | Required before MD5 license |
| Manufacturing License (MD5) | 3 to 4 months | Includes audit and testing |
| Import License (MD15) | 5 to 6 months | No test license required |
Government Fees and Costs
| License Type | Application Fee | Per Product Fee | Total Approximate Cost |
|---|---|---|---|
| MD5 (Class B) | Rs. 5,000 | Rs. 500 | Rs. 5,500 + audit costs |
| MD15 (Import, Class B) | USD 2,000 (approx Rs.1.6 Lakh) | USD 1,000 (approx Rs.80,000) | USD 3,000 + other charges |
Note: Fees are subject to change; always verify with the latest CDSCO notifications.
Common Challenges and Practical Solutions
Delays in Testing: Testing at government-approved labs can bottleneck the timeline. Early appointment booking and sample preparation can mitigate delays.
Incomplete Documentation: Missing or inconsistent documents often cause rejections. Utilize detailed checklists and expert document review prior to submission.
Audit Non-Compliance: Facilities not meeting GMP or QMS standards fail audits. Conduct internal mock audits to identify gaps beforehand.
Query Resolution Delays: Prompt and accurate responses to CDSCO queries expedite approvals. Assign dedicated regulatory staff for follow-up.
Expert Consultation and Support
Navigating CDSCO licensing for Class B devices like NasoGastric tubes requires precision and compliance expertise. Our seasoned consultancy has successfully supported over 500 manufacturers and importers across India. We offer:
- Comprehensive gap analysis and documentation assistance
- Coordination with notified bodies and testing labs
- Strategic planning to optimize timelines and costs
- Training on regulatory updates and compliance best practices
Partnering with experts minimizes risks and accelerates your market entry.
Getting Started with Your CDSCO License Application for NasoGastric Tubes
Determine Your License Type: Confirm whether you need an MD5 manufacturing license or an MD15 import license based on your business model.
Create an Account on the CDSCO MD Online Portal: This is mandatory for all application submissions.
Engage a CDSCO-Approved Testing Laboratory: Early engagement helps schedule product testing timely.
Prepare Required Documentation: Use our comprehensive checklists and guides to compile Device Master File, Plant Master File, and other necessary documents.
Apply for Test License (if manufacturing): Submit Form MD13 and await approval to begin testing.
Submit Your License Application: Upload all documents and forms via the CDSCO portal.
Schedule and Prepare for Audit: Coordinate with notified bodies for on-site inspection.
Respond to Queries Promptly: Assign a regulatory liaison to manage communications.
Receive Your License and Begin Production or Import: Once granted, maintain compliance with post-market obligations.
For detailed assistance and personalized support, connect with our regulatory experts to streamline your CDSCO licensing journey for NasoGastric tubes.
By following this detailed roadmap and leveraging expert insights, manufacturers and importers can efficiently secure CDSCO approvals for NasoGastric tubes, ensuring timely access to the Indian healthcare market.
