CDSCO License for Oxygen administration tent, neonatal/paediatric

Comprehensive Guide to CDSCO Licensing for Oxygen Administration Tent, Neonatal/Paediatric (Class A Medical Device)

As specialists with over 25 years of experience in medical device regulatory affairs, we understand the critical importance of securing timely and compliant licenses from the Central Drugs Standard Control Organization (CDSCO) to market devices like the Oxygen Administration Tent for neonatal and paediatric use in India. This flexible enclosure device, designed to provide an enriched oxygen environment for infants and children, falls under Class A, the lowest risk category, yet requires adherence to strict regulatory protocols to ensure patient safety and legal compliance.

CDSCO Regulatory Framework for Oxygen Administration Tent

The CDSCO classifies medical devices into four risk categories: A, B, C, and D. The Oxygen Administration Tent is classified as Class A, indicating low risk. Regulatory oversight for Class A devices is primarily under the State Licensing Authorities, with specific requirements governed by the Medical Device Rules (MDR) 2017 and subsequent amendments. The regulatory framework mandates obtaining a manufacturing license (MD5) for local production and an import license (MD15) for devices brought into India.

Risk Classification and License Requirements for Oxygen Administration Tent

• Risk Class: A (Low risk)
• License Type: MD5 Manufacturing License (Form MD3)
• Licensing Authority: State Licensing Authority
• Applicable Rules: Medical Device Rules, 2017
• Notification Reference: File No. 29/MiscJ03/2020-DC (150), dated 23.8.2021

Given its reusable nature and paediatric application, manufacturers must ensure compliance with all quality, safety, and performance standards mandated for Class A devices.

Manufacturing License Process (MD5) for Class A Devices

The MD5 license is mandatory for manufacturing the Oxygen Administration Tent in India. The process involves several key steps:

1. Test License Application (Form MD13): Before full manufacturing license approval, a test license is required to produce limited batches for performance testing.
2. Product Testing: Samples must be tested at government-approved laboratories to verify conformity with applicable standards.
3. Document Preparation: Compilation of a comprehensive dossier including technical, quality, and safety documentation.
4. Application Submission (Form MD3): Applying for the MD5 manufacturing license through your State Licensing Authority.
5. Audit by Notified Body: An on-site audit verifies compliance with Good Manufacturing Practices (GMP).
6. Query Resolution: Addressing any observations or deficiencies raised during the audit or document review.
7. License Grant (Form MD5): Upon satisfactory completion, the State Authority issues the manufacturing license.

Manufacturers can submit applications and track progress via the CDSCO MD Online Portal.

Manufacturing License Documents Required for Oxygen Administration Tent

For the MD5 license application, the following documents are essential:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire Safety and Pollution Control NOCs
• Device Master File (DMF): Detailed device specifications, manufacturing processes, quality controls (Device Master File Guide)
• Plant Master File (PMF): Description of manufacturing facility, equipment, and processes (Plant Master File Guide)
• Essential Principles Checklist demonstrating compliance with safety and performance
• Risk Management File outlining hazard analysis and mitigation strategies (Risk Management)
• Test Reports from government-approved laboratories (Testing Laboratories)
• Product Labels, Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485:2016 certification

Import License Process (MD15) for Oxygen Administration Tent

If you are an importer, an MD15 license from the Central Licensing Authority is required. The process is more centralized and includes:

• Preparation of import dossier including manufacturing license from the country of origin
• Submission of application on Form MD14 via the CDSCO MD Online Portal
• Resolution of queries raised by CDSCO
• Grant of import license (Form MD15)

Documents required include:

• Valid manufacturing license of the device from the country of origin
• Free Sale Certificate
• ISO 13485:2016 and CE Certificate
• Device and Plant Master Files
• Wholesale drug license
• Company Constitution

Government fees vary based on device class; for Class A, it is approximately $1000 per site and$50 per product.

Timeline and Processing Duration

For the Oxygen Administration Tent (Class A), expect the following timeframes:

• Test License (MD13): 1.5 to 2 months
• Product Testing: 3 to 6 weeks, depending on laboratory queue
• Document Preparation: Typically 2 to 4 weeks
• MD5 License Application Processing: 1.5 to 2 months

Overall, the entire manufacturing license process averages 3 to 4 months. For imports, expect 5 to 6 months due to centralized processing.

Government Fees and Costs

• MD5 Manufacturing License: Rs. 5,000 per application + Rs. 500 per product
• Testing Fees: Variable, depending on laboratory and number of tests
• Audit Fees: Payable to the notified body conducting GMP audit

Given the Oxygen Administration Tent is a Class A device, the financial investment remains moderate compared to higher-class devices.

Common Challenges and Solutions

Challenge: Delays in product testing due to laboratory backlog.

Solution: Engage with multiple government-approved labs listed on the CDSCO testing laboratories page early in the process to schedule testing slots.

Challenge: Incomplete or inconsistent documentation causing audit observations.

Solution: Prepare detailed Device and Plant Master Files and conduct internal audits before official notified body audits. Our MD5 License Guide provides a stepwise approach.

Challenge: Unclear risk management documentation.

Solution: Implement a robust risk management system tailored to paediatric devices, guided by our Risk Management resource.

Expert Consultation and Support

Having supported over 500 companies in obtaining CDSCO licenses, our consultancy offers end-to-end assistance:

• Gap analysis for existing documentation
• Preparation and review of Device and Plant Master Files
• Scheduling and liaison with notified bodies for audits
• Strategic guidance on timelines and regulatory updates
• Hands-on support for application submission via the CDSCO MD Online Portal

Getting Started with Your CDSCO License Application

To initiate your MD5 license application for the Oxygen Administration Tent:

1. Register on the CDSCO MD Online Portal: Create your company profile and submit basic details.
2. Apply for Test License (MD13): Begin with the test license to initiate manufacturing of sample batches.
3. Plan Product Testing: Coordinate with approved laboratories early to avoid delays.
4. Compile Technical Documentation: Develop comprehensive Device and Plant Master Files along with risk management documentation.
5. Engage a Notified Body: Identify and schedule an audit with a notified body from the official list.
6. Submit MD5 Application (Form MD3): Upload all documents through the portal.
7. Prepare for Audit and Queries: Be ready to promptly address any queries raised.

Starting early and maintaining clear communication with regulatory bodies significantly improves your chances of a smooth approval process.

For detailed guidance tailored to your manufacturing setup and to avoid common pitfalls, contact our experienced regulatory consultants today. Together, we ensure your Oxygen Administration Tent reaches the Indian market efficiently and compliantly.