CDSCO License for Nasogastric tube holder, intranasal
Medical Device Information
Intended Use
A non-sterile, non-surgically invasive device intended to be used to secure a nasogastric tube to the nose of a patient to prevent displacement or removal of the tube.
Comprehensive Guide to CDSCO Licensing for Nasogastric Tube Holder (Intranasal) – Class B Medical Device
At our firm, with over 25 years of extensive experience in medical device regulatory affairs, we have successfully guided more than 500 companies through the intricacies of obtaining CDSCO licenses across India. Today, we focus on an essential yet often overlooked device in gastroenterology—the Nasogastric Tube Holder, Intranasal, classified as a Class B medical device under CDSCO regulations.
Understanding the Nasogastric Tube Holder and Its Regulatory Importance
The nasogastric tube holder is a non-sterile, non-surgically invasive device designed to securely fasten a nasogastric tube to a patient’s nose, preventing accidental displacement or removal. Despite its simple design, regulatory compliance is critical for market access and patient safety. The device falls under the gastroenterology category with the official CDSCO notification number 29/Misc./03/2020-DC (182) dated 27.09.2021.
CDSCO Regulatory Framework for Nasogastric Tube Holder (Class B)
As per the Medical Device Rules, 2017, the Nasogastric Tube Holder is classified as a Class B device, which demands adherence to a streamlined but thorough regulatory process. The licensing authority for Class B devices is the State Licensing Authority, and manufacturers must obtain the MD5 Manufacturing License (Form MD3) to legally manufacture this device in India.
Risk Classification and License Requirements
- Risk Class: B (Low moderate risk)
- License Type: MD5 Manufacturing License
- Regulatory Authority: State Licensing Authority
- Total Timeframe: Approximately 3 to 4 months
Manufacturers must complete a test license phase (Form MD13) before applying for the MD5 license, involving product testing and an audit by notified bodies.
Manufacturing License Process for Nasogastric Tube Holder (MD5)
Apply for Test License (MD13): The initial step involves securing a test license, which typically takes 1.5 to 2 months. This license allows the manufacturer to produce samples for testing.
Product Testing: Testing must be conducted at CDSCO-approved laboratories. For your convenience, consult the list of approved testing laboratories to select an accredited facility.
Document Preparation: Compile comprehensive documentation as per CDSCO requirements.
Submit MD5 Application (Form MD3): Submit your complete application via the CDSCO MD Online Portal.
Audit by Notified Body: A mandatory audit from a notified body is conducted to verify compliance. Refer to the list of notified bodies for audit assignments.
Respond to Queries: Address any queries or deficiencies raised by CDSCO or the notified body promptly.
License Grant: Upon satisfactory completion of all requirements, CDSCO grants the MD5 license on Form MD5.
Documents Required for MD5 Manufacturing License
For a Class B device like the nasogastric tube holder, thorough documentation is crucial. Key documents include:
- Company Constitution and Incorporation Certificate
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Qualifications and Experience
- Fire and Pollution NOCs
- Device Master File (DMF): Our comprehensive Device Master File guide can assist in preparing this essential document.
- Plant Master File (PMF): Detailed description of the manufacturing site. Reference our Plant Master File guide for best practices.
- Essential Principles Checklist
- Risk Management File: Implementing risk management is critical; see our Risk Management guide.
- Test Reports from Approved Labs
- Labels and Instructions for Use (IFU)
- Quality Management System Documents (e.g., ISO 13485 certification)
Import License Process (MD15) for Nasogastric Tube Holder
If you plan to import the nasogastric tube holder into India, the process differs:
- Importers must apply for an MD15 Import License (Form MD14) through the Central Licensing Authority.
- Unlike manufacturing, a test license is not required.
- Submit documents such as:
- Valid manufacturing license from the country of origin
- Free Sale Certificate
- ISO 13485:2016 certification
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale Drug License
- Company Constitution
- The application is processed over 5 to 6 months via the CDSCO MD Online Portal.
Timeline and Processing Duration
| Step | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 3 – 4 weeks |
| Documentation Preparation | 2 – 3 weeks |
| MD5 License Application | 1 week (submission) |
| Notified Body Audit | 3 – 4 weeks |
| Query Resolution & Final Grant | 3 – 4 weeks |
| Total Time (Manufacturing) | 3 to 4 months |
Government Fees and Costs
- Test License (MD13): Approximately Rs. 5000 (varies by state)
- MD5 License Application Fee: Rs. 5000 per application
- Fee per Product: Rs. 500 for each product registered (i.e., per device variant or model)
- Notified Body Audit Fee: Typically ranges between Rs. 50,000 to Rs. 1,00,000 depending on the auditor
Budget for approximately Rs. 1.2 to 1.5 lakhs inclusive of testing and audit fees for a single product.
Common Challenges and Practical Solutions
- Incomplete Documentation: Many applicants overlook detailed Device and Plant Master Files. Utilize our guides for comprehensive document preparation.
- Delayed Product Testing: Selection of a CDSCO-approved lab early in the process prevents bottlenecks. Book testing slots well in advance.
- Audit Non-Compliance: Conduct internal mock audits to identify gaps before the notified body visit.
- Query Management: Maintain open communication with CDSCO and respond to queries within deadlines to avoid delays.
Expert Consultation and Support
Given the complexity of regulatory requirements, especially for Class B devices, expert guidance is invaluable. Our team assists manufacturers and importers with:
- Preparing and reviewing all regulatory documents
- Coordinating product testing and audit schedules
- Liaising with CDSCO and notified bodies
- Providing training on Quality Management Systems and risk management
We leverage our deep expertise to streamline your CDSCO licensing journey, minimizing risks and accelerating time-to-market.
Getting Started with Your CDSCO License Application for Nasogastric Tube Holder
Evaluate Device Classification: Confirm your device’s Class B status under the Medical Device Classification guide.
Register on CDSCO MD Online Portal: Create your account to access all forms and submission portals.
Compile Technical Documentation: Start with Device Master File and Plant Master File preparation.
Apply for Test License (MD13): This is the mandatory first step before manufacturing.
Schedule Product Testing: Engage a CDSCO-approved testing lab immediately after test license approval.
Prepare for Audit: Conduct internal audits and gather all evidence for notified body inspection.
Submit MD5 Application: Upload all documents and pay fees via the CDSCO MD Online Portal.
Monitor Application Status and Respond Promptly: Timely responses to queries ensure smooth processing.
By following these tailored, practical steps, manufacturers and importers of nasogastric tube holders can confidently navigate the CDSCO licensing process, ensuring compliance and unlocking access to the vast Indian healthcare market.
For personalized assistance, reach out to our regulatory experts who have successfully facilitated over 500 CDSCO licensing approvals. Together, we can make your product journey seamless and compliant.
