CDSCO License for Nasogastric tube holder, noninvasive, sterile
Medical Device Information
Important Notice for Class A Devices
Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).
Intended Use
A small, sterile, noninvasive device intended to be used to secure a nasogastric tube to prevent displacement or removal of the tube from the patient.
Comprehensive Guide to CDSCO Licensing for Nasogastric Tube Holder, Noninvasive, Sterile (Class A Medical Device)
As a trusted regulatory consultancy with over 25 years of experience and having successfully assisted 500+ medical device companies, we understand the critical importance of securing the correct CDSCO license for your medical device. In this guide, we focus on the nasogastric tube holder, noninvasive, sterile — a Class A medical device in the gastroenterology category — and provide detailed insights to help manufacturers and importers navigate the CDSCO regulatory framework effectively.
Understanding the Nasogastric Tube Holder & Its Regulatory Importance
The nasogastric tube holder is a small, sterile, and noninvasive device designed to securely fasten a nasogastric tube, preventing unintended displacement or removal. Given its direct application to patient care, regulatory oversight ensures the device’s safety, sterility, and quality before entering the Indian market.
With the CDSCO notification 29/Misc./03/2020-DC (182) dated 27.09.2021, this device falls under Class A, representing the lowest risk category but still subject to licensing and compliance requirements.
CDSCO Regulatory Framework for Nasogastric Tube Holder (Class A)
In India, medical devices are regulated by the Central Drugs Standard Control Organization (CDSCO) under the Medical Device Rules, 2017. The nasogastric tube holder, being a Class A device, requires a manufacturing license granted by the State Licensing Authority through the MD5 license process.
Manufacturers must comply with the quality standards, get their device tested in government-approved laboratories, and undergo audit inspections to ensure conformity with the essential principles and risk management practices.
Risk Classification and License Requirements
| Device Type | Risk Class | Licensing Authority | License Form | Typical Timeline | Government Fees |
|---|---|---|---|---|---|
| Nasogastric tube holder | A | State Licensing Authority | MD5 (Form MD3) | 3-4 months | Rs 5000 per application + Rs 500 per product |
For detailed classification, consult the Medical Device Classification guide.
Manufacturing License Process (MD5) for Class A Devices
The MD5 license is mandatory for manufacturing Class A devices like the nasogastric tube holder. The process involves several key steps:
Test License Application (Form MD13): Obtain a test license valid for 1.5 to 2 months to conduct necessary product testing.
Product Testing: Get the device tested at a CDSCO-recognized laboratory to confirm compliance with safety and performance standards. Refer to the Testing Laboratories list.
Documentation Preparation: Compile all required documents, including technical files and quality management system records.
License Application (Form MD3): Submit the application for the MD5 license on the CDSCO MD Online Portal.
Audit by Notified Body: Undergo inspection and audit by a CDSCO-notified body. Check the Notified Bodies list to select an accredited auditor.
Query Resolution: Respond promptly to any queries raised during the audit or review.
Grant of License (Form MD5): Upon satisfactory completion, the State Licensing Authority grants the manufacturing license.
Manufacturing License Documents Required
For the nasogastric tube holder manufacturing license, prepare the following documents:
- Company Constitution and Incorporation Certificates
- Proof of Ownership or Lease of Manufacturing Premises
- Details and Qualification Certificates of Technical Staff
- Fire Safety NOC and Pollution Control Board NOC
- Device Master File (DMF): Detailed device specifications, manufacturing process, and validation (Device Master File Guide)
- Plant Master File (PMF): Facility details, equipment, and quality assurance systems (Plant Master File Guide)
- Essential Principles Checklist aligned with Indian MDR
- Risk Management File highlighting hazard analysis and mitigation (Risk Management Guide)
- Test Reports from Government Approved Labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents, preferably ISO 13485 certified
Import License Process (MD15) for Nasogastric Tube Holder
If you are an importer of the nasogastric tube holder, the import license (MD15) is granted by the Central Licensing Authority. The process takes approximately 5-6 months.
Key steps include:
Compile required documents such as manufacturing license, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, and wholesale license.
Submit the application on the CDSCO MD Online Portal.
Address any queries during the evaluation.
Upon approval, receive the import license (Form MD15).
For detailed guidance, see our Import License Guide.
Import License Documents Required
- Valid Manufacturing License from Country of Origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate or Equivalent
- Device Master File
- Plant Master File
- Wholesale License
- Company Constitution and Address Proof
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| License Application Review | 1 - 1.5 months |
| Audit & Query Resolution | 1 month |
| Total Time for MD5 License | 3 - 4 months |
For imports (MD15 license), anticipate 5-6 months from application submission to license grant.
Government Fees and Costs
MD5 License (Manufacturing Class A): Rs 5000 per application + Rs 500 per product
Test License (MD13): Fees are generally nominal but check with the State Authority
Import License (MD15): Class A fees approximately 50 per product
Note: Additional costs include notified body audit fees, laboratory testing charges, and document preparation expenses.
Common Challenges and Solutions
Challenge 1: Delays in Product Testing
- Solution: Engage with CDSCO-approved labs early and confirm testing timelines. Maintain clear communication to avoid bottlenecks.
Challenge 2: Incomplete Documentation
- Solution: Use comprehensive checklists and refer to expert guides like our Device Master File guide to ensure completeness.
Challenge 3: Audit Non-Compliance
- Solution: Conduct internal mock audits before the notified body inspection to identify gaps.
Challenge 4: Query Resolution Delays
- Solution: Assign a dedicated regulatory officer to respond promptly to CDSCO queries to avoid prolonging the process.
Expert Consultation and Support
Navigating the CDSCO licensing process can be complex, especially with evolving regulatory requirements. Our extensive experience in supporting over 500 companies means we offer:
- Tailored regulatory strategy for your nasogastric tube holder
- End-to-end documentation support including DMF and PMF preparation
- Liaison with notified bodies and CDSCO officials
- Training on compliance and audit readiness
Getting Started with Your CDSCO License Application
Assess your device classification: Confirm your nasogastric tube holder is Class A under CDSCO MDR.
Prepare documentation: Begin compiling master files, risk management, and QMS documents.
Apply for test license: Submit Form MD13 application on the CDSCO MD Online Portal to start product testing.
Engage notified body early: Schedule audits by referring to the Notified Bodies list.
Maintain proactive communication: Track your application status regularly and prepare to respond quickly to queries.
By following this roadmap and leveraging expert support, you can efficiently obtain your CDSCO manufacturing license for the nasogastric tube holder, enabling timely market entry and compliance assurance.
For personalized assistance and detailed regulatory consulting, feel free to contact us — your trusted partner in medical device regulatory compliance in India.
