CDSCO License for Nasal Oxygen Catheter

Comprehensive Guide to CDSCO Licensing for Nasal Oxygen Catheters (Class B Medical Device)

Nasal Oxygen Catheters are vital medical devices designed to deliver supplemental oxygen or increased airflow to patients requiring respiratory support. Classified under Class B by the Central Drugs Standard Control Organization (CDSCO), these catheters fall into the low to moderate risk category under India's medical device regulatory framework. Given their critical role in respiratory care, securing the appropriate CDSCO license is essential before manufacturing or importing these devices in India.

With over 25 years of regulatory consulting experience and having assisted 500+ companies, we provide you with a detailed roadmap to navigate the CDSCO licensing for Nasal Oxygen Catheters efficiently.

CDSCO Regulatory Framework for Nasal Oxygen Catheters

The CDSCO regulates medical devices in India under the Medical Device Rules (MDR) 2017, notified vide 29/Misc/3/2017-DC (292) dated 06.06.2018. Nasal Oxygen Catheters are classified as Class B devices under MDR, indicating a low to moderate risk profile.

Manufacturing and importing these devices require compliance with quality, safety, and efficacy standards as outlined by CDSCO. The regulatory framework mandates manufacturers to obtain MD5 licenses for manufacturing and MD15 licenses for import.

Risk Classification and License Requirements

• Device: Nasal Oxygen Catheter
• Risk Class: B (Low to Moderate Risk)
• License Type: MD5 (Manufacturing License)
• Regulatory Authority: State Licensing Authority (for manufacturing)
• Import License: MD15, under Central Licensing Authority

Understanding the risk classification is crucial as it determines the license type, application process, fees, and documentation required. For Class B devices like Nasal Oxygen Catheters, the MD5 license procedure applies.

Manufacturing License Process (MD5) for Nasal Oxygen Catheters

The MD5 license for manufacturing Class B devices is granted by the State Licensing Authority. The entire process typically takes 3 to 4 months and involves multiple stages:

1. Test License (Form MD13): Before applying for the manufacturing license, manufacturers must obtain a test license for 1.5 to 2 months. This allows the company to conduct product testing.
2. Product Testing: Testing must be conducted at CDSCO-approved laboratories to verify compliance with applicable standards.
3. Document Preparation: Compile all technical, quality, and compliance documents.
4. Application Submission (Form MD3): Submit the MD5 license application through the CDSCO MD Online Portal.
5. Audit by Notified Body: A notified body, listed in the Notified Bodies List for MD5 Audit, will audit the manufacturing facility and documentation.
6. Query Resolution: Address any queries or observations raised by the department or the notified body.
7. License Grant (Form MD5): Upon satisfactory review and audit, the MD5 license is granted.

Manufacturing License Documents Required for Nasal Oxygen Catheters

To ensure a smooth application process, prepare the following documents meticulously:

• Company Constitution Documents: Incorporation certificate, Memorandum & Articles of Association
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Details: Qualification and experience certificates
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF): Includes detailed technical specifications, design, manufacturing process. Refer to our comprehensive Device Master File guide.
• Plant Master File (PMF): Details on manufacturing facilities and quality control systems. Learn more from our Plant Master File guide.
• Essential Principles Checklist: Demonstrating compliance with safety and performance requirements
• Risk Management File: Documenting identified risks and mitigation strategies, aligned with ISO 14971 standards. See our Risk Management guide.
• Test Reports: From CDSCO-approved labs confirming device compliance
• Labels and Instructions for Use (IFU): Must comply with MDR requirements
• Quality Management System Documents: ISO 13485:2016 certification and QMS procedures

Import License Process (MD15) for Nasal Oxygen Catheters

If you plan to import Nasal Oxygen Catheters into India, you need an MD15 import license granted by the Central Licensing Authority. The process typically takes 5 to 6 months.

Steps include:

1. Document Preparation: Gather required documents including the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485, CE Certificate, Device Master File, Plant Master File, wholesale license, and company constitution.
2. Application Submission: File the application on the CDSCO MD Online Portal using Form MD14.
3. Query Resolution: Respond promptly to any queries from CDSCO.
4. License Grant: Upon compliance verification, the MD15 license is issued.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate or equivalent
• Device Master File
• Plant Master File
• Wholesale License (if applicable)
• Company Constitution Documents

Timeline and Processing Duration

Proactively preparing documents and promptly addressing queries can significantly reduce delays.

Government Fees and Costs

For Nasal Oxygen Catheters (Class B) under MD5 manufacturing license:

• Application Fee: Rs 5,000 per application
• Product Fee: Rs 500 per product

Additional costs include testing fees at government-approved laboratories and audit fees charged by notified bodies.

For import (MD15 license), fees vary by risk class and number of products. For Class B:

• Site Fee: Approximately $2,000
• Product Fee: Approximately $1,000 per product

Common Challenges and Solutions

• Delayed Testing Results: Engage with CDSCO-approved labs early. Refer to the Testing Laboratories list to select an accredited lab with proven turnaround times.
• Incomplete Documentation: Use detailed checklists and templates for Device and Plant Master Files. Our guides simplify this process.
• Audit Non-Compliance: Prepare your facility in advance by conducting internal audits and training staff on regulatory requirements.
• Query Resolution Delays: Assign a dedicated regulatory liaison to respond promptly and comprehensively to CDSCO queries.

Expert Consultation and Support

Navigating CDSCO licensing for Nasal Oxygen Catheters can be complex. With our extensive experience assisting over 500 manufacturers and importers, we offer tailored consulting services that include:

• Gap analysis of your current compliance status
• Preparation of Device and Plant Master Files
• Coordination with notified bodies and testing labs
• End-to-end application filing and follow-up

Engage expert consultants to streamline your regulatory journey and avoid costly delays.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm that your Nasal Oxygen Catheter is Class B.
2. Initiate Product Testing: Apply for a test license (Form MD13) via the CDSCO MD Online Portal.
3. Prepare Documentation: Use our Device Master File and Plant Master File guides to compile robust dossiers.
4. Select Notified Body: Choose a notified body from the official list for audit scheduling.
5. Submit MD5 License Application: Once testing is complete, apply with Form MD3.
6. Prepare for Audit: Conduct internal readiness checks and ensure all documentation and manufacturing processes comply.
7. Resolve Queries Promptly: Maintain proactive communication with CDSCO and the notified body.

Taking these actionable steps early will ensure compliance and timely entry of your Nasal Oxygen Catheter into the Indian market.

For personalized assistance, reach out to our regulatory experts who specialize in CDSCO medical device licensing. Together, we can help you achieve successful market approval with confidence.