CDSCO License for Nasogastric tube holder, noninvasive, non-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, non-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 Obtaining CDSCO License for Nasogastric Tube Holder (Class A)
At our consultancy, with over 25 years in medical device regulatory affairs, we have supported more than 500 companies in acquiring CDSCO licenses across India. This guide focuses on the nasogastric tube holder, noninvasive, non-sterile, a Class A medical device under the gastroenterology category, detailing the regulatory pathway, document requirements, costs, and timelines to help you navigate the process efficiently.
Introduction: Understanding the Nasogastric Tube Holder and Its Regulatory Importance
The nasogastric tube holder is a small, noninvasive, and non-sterile device designed to secure nasogastric tubes, preventing displacement or accidental removal during patient care. Despite its simplicity, it is crucial to comply with CDSCO regulations to ensure patient safety and legal market entry in India. The device falls under Class A, the lowest risk category, but still requires proper licensing and compliance.
CDSCO Regulatory Framework for Nasogastric Tube Holders
The Central Drugs Standard Control Organization (CDSCO) governs medical device licensing in India, with a structured framework based on device risk classification. For Class A devices like the nasogastric tube holder, licenses are issued by the State Licensing Authority under the MD5 license category, as per the notification 29/Misc./03/2020-DC (182).
Manufacturers must obtain the MD5 license (Form MD3 application) to legally produce and market this device. Importers require a separate import license (MD15), but this guide focuses on manufacturing licensing.
Risk Classification and License Requirements for Class A Devices
Class A devices are considered low risk. The CDSCO mandates the following for these devices:
- MD5 Manufacturing License: Issued by the State Licensing Authority.
- Test License (MD13): A prerequisite for product testing before applying for MD5.
- Product Testing: Mandatory from government-approved testing laboratories.
For nasogastric tube holders, this classification simplifies the process compared to higher risk devices.
Manufacturing License Process (MD5) for Nasogastric Tube Holder
The typical process involves:
- Obtain Test License (Form MD13): Apply via the CDSCO MD Online Portal to get permission for sample testing. This takes approximately 1.5 to 2 months.
- Product Testing: Submit your samples to government-approved laboratories listed on the CDSCO site to validate safety and performance.
- Document Preparation: Assemble all required technical and compliance documentation.
- Apply for MD5 License (Form MD3): Submit the manufacturing license application through the online portal.
- Audit by Notified Body: The State Licensing Authority will assign an audit by a notified body to verify compliance. The list of notified bodies is publicly accessible.
- Resolve Queries: Address any observations or queries raised by auditors or authorities.
- Grant of License (Form MD5): After satisfactory audit and documentation, the license is granted.
Manufacturing License Documents Required
For the nasogastric tube holder (Class A), ensure the following documents are prepared meticulously:
- Company Constitution Documents (Incorporation certificate, Memorandum & Articles of Association)
- Proof of Premises Ownership or Lease Agreement
- Technical Staff Details (Qualifications, experience of key personnel)
- Fire NOC & Pollution Control NOC from relevant authorities
- Device Master File (DMF): Detailed device description, design, and manufacturing process. Our Device Master File guide provides comprehensive insights.
- Plant Master File (PMF): Manufacturing site details. Refer to our Plant Master File guide.
- Essential Principles Checklist: Confirmation of compliance with Indian medical device regulations
- Risk Management File: Documentation of risk assessments and mitigation strategies. Learn more about risk management.
- Test Reports from government-approved labs (Testing Laboratories)
- Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents (ISO 13485 certification is highly recommended)
Import License Process (MD15) for Nasogastric Tube Holder
Although this guide centers on manufacturing licenses, importers must apply for the MD15 license from CDSCO Central Licensing Authority. The process takes 5-6 months and requires:
- Valid manufacturing license from the country of origin
- Free Sale Certificate
- ISO 13485:2016 certification
- CE Certificate (if applicable)
- Device and Plant Master Files
- Wholesale license
- Company constitution documents
For detailed import licensing steps, consult our Import License guide.
Timeline and Processing Duration
| Step | Duration |
|---|---|
| Test License Application | 1.5 – 2 months |
| Product Testing | 2 – 3 weeks |
| Document Preparation | 2 – 4 weeks |
| MD5 License Application | 1 month (including audit and queries) |
| Total Estimated Time | 3 – 4 months |
Being proactive with documentation and audit readiness can significantly reduce delays.
Government Fees and Costs
- Test License (MD13): No separate fee but included in licensing costs
- MD5 License Application Fee: ₹5,000 per application
- Product Fee: ₹500 per product
Additional costs include testing fees at government-approved laboratories, audit fees charged by notified bodies, and internal compliance costs.
Common Challenges and Solutions
Challenge 1: Delays in Test License Approval
- Solution: Submit complete and accurate documentation from the outset. Engage with notified bodies early.
Challenge 2: Incomplete or Non-compliant Documentation
- Solution: Use checklists and templates. Our detailed document guides can help avoid common errors.
Challenge 3: Audit Observations Leading to Queries
- Solution: Prepare your manufacturing site and QMS thoroughly. Conduct internal audits before the notified body audit.
Challenge 4: Testing Laboratory Backlogs
- Solution: Identify multiple government-approved labs and plan submissions accordingly.
Expert Consultation and Support
With 25+ years of regulatory consulting experience, we offer end-to-end support—from initial classification to final license grant. Our services include:
- Preparing and reviewing Device and Plant Master Files
- Coordinating with notified bodies and testing labs
- Managing audit readiness
- Handling application submissions and queries
Our expert team ensures your nasogastric tube holder license process is smooth, timely, and compliant.
Getting Started with Your CDSCO License Application
- Confirm Device Classification: Verify your device is correctly classified as Class A using the Medical Device Classification tool.
- Prepare Your Test License Application (Form MD13): Register and submit online via the CDSCO MD Online Portal.
- Collect and Submit Samples for Testing: Choose from government-approved labs.
- Assemble Required Documentation: Utilize our device and plant master file guides for accuracy.
- Plan for Audit: Schedule with a notified body from the official list.
- Apply for MD5 License (Form MD3): Submit post-successful testing.
Starting early and leveraging expert guidance can reduce your overall approval timeline and help you avoid costly pitfalls.
For personalized assistance or to begin your licensing journey, reach out to our regulatory consultants today and leverage our proven track record in facilitating successful CDSCO medical device approvals.
