CDSCO License for Oxygen administration hood

Introduction to Oxygen Administration Hood and Its Regulatory Importance

The Oxygen Administration Hood is a critical medical device used primarily in anesthesiology to provide an enriched oxygen environment around a patient head, thereby enhancing oxygen uptake. This rigid, transparent plastic enclosure is designed for adult patients needing supplemental oxygen in clinical settings. Given its role in patient care and safety, the Oxygen Administration Hood is regulated under the Indian medical device framework to ensure its quality, safety, and efficacy.

Navigating the Central Drugs Standard Control Organization (CDSCO) licensing process is essential for manufacturers and importers aiming to market this device in India. With over 25 years of experience assisting more than 500 companies in obtaining CDSCO licenses, we understand the nuances of the regulatory pathway for Class A medical devices like the Oxygen Administration Hood.

CDSCO Regulatory Framework for Oxygen Administration Hood

The CDSCO governs medical device approvals in India under the Medical Device Rules (MDR) 2017, which classify devices based on risk. The Oxygen Administration Hood falls under Class A (low risk), regulated primarily by the State Licensing Authority.

This device is notified under Notification Number 29/Misc/03/2020-DC(177) dated 12.07.2021, making regulatory compliance mandatory before manufacturing or marketing.

Risk Classification and License Requirements

• Device: Oxygen Administration Hood
• Risk Class: Class A (Low Risk)
• Regulatory License Required: MD5 Manufacturing License (Form MD3)
• Regulating Authority: State Licensing Authority

Class A devices require obtaining the MD5 license, which is a state-level manufacturing license. The process includes a mandatory test license (MD13), product testing by government-approved labs, audit by notified bodies, and compliance with essential principles.

Manufacturing License Process (MD5) for Oxygen Administration Hood

1. Apply for Test License (Form MD13): The first step involves applying for a test license, which allows you to manufacture the device for testing purposes only. This license is valid for 3 months and takes approximately 1.5 to 2 months to be granted.

2. Product Testing: After obtaining the test license, have the Oxygen Administration Hood tested at one of the government-approved testing laboratories. Testing focuses on safety, material compliance, and functionality.

3. Document Preparation: Simultaneously, prepare all required documentation, including Device Master File, Plant Master File, and Risk Management File.

4. Apply for Manufacturing License (Form MD3): Once testing is complete, submit the application for the MD5 license on the CDSCO MD Online Portal.

5. Audit by Notified Body: A notified body from the official list will conduct an audit of your manufacturing facility and quality management system.

6. Resolution of Queries: Respond promptly to any queries or observations raised by the licensing authority or notified body.

7. Grant of MD5 License: Upon satisfactory compliance, the State Licensing Authority grants the MD5 license, authorizing manufacturing.

Manufacturing License Documents Required for Oxygen Administration Hood

• Company Constitution Documents: Incorporation certificate, partnership deed, etc.
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Details: Qualification and experience certificates
• Fire NOC and Pollution Control NOC
• Device Master File: Detailed device description, design, manufacturing process (Guide here)
• Plant Master File: Manufacturing facility details and standard operating procedures (Guide here)
• Essential Principles Checklist: Compliance with Indian Medical Device Rules and standards
• Risk Management File: Hazard analysis and mitigation strategies (Learn more)
• Test Reports: From government-approved labs demonstrating compliance
• Labels and Instructions for Use (IFU): Clear and compliant
• Quality Management System Documents: ISO 13485:2016 certification and related SOPs

Import License Process (MD15) for Oxygen Administration Hood

While the Oxygen Administration Hood is a Class A device, imported devices require an MD15 Import License issued by the Central Licensing Authority.

Steps include:

1. Document Preparation: Gather manufacturing license from the country of origin, ISO 13485 certificate, Free Sale Certificate, CE certificate (if applicable), Device Master File, and Plant Master File.

2. Application Submission: File Form MD14 on the CDSCO MD Online Portal.

3. Queries Resolution: Address any additional clarifications sought by the CDSCO.

4. Grant of MD15 License: After review, the import license is granted.

Note: Unlike manufacturing licenses, no test license is required for imports.

Import License Documents Required

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

Timeline and Processing Duration

Planning well in advance and parallelizing documentation and testing can help expedite the process.

Government Fees and Costs

Example: For a single product application, expect to pay around INR 5,500.

Additional costs include testing fees at government labs and notified body audit charges, which vary but typically range from INR 50,000 to 1,00,000 depending on the notified body selected.

Common Challenges and Solutions

• Delays in Test License Approval: Proactively prepare and submit a comprehensive application to avoid queries. Engage with CDSCO consultants if necessary.

• Product Testing Failures: Choose accredited testing labs and conduct internal pre-testing to ensure compliance.

• Incomplete Documentation: Use detailed checklists and templates for Device and Plant Master Files.

• Audit Non-Compliance: Maintain a robust Quality Management System and conduct internal audits before notified body visits.

• Query Management: Respond promptly and clearly to all CDSCO or notified body queries to avoid delays.

Expert Consultation and Support

With our extensive experience supporting over 500 clients through CDSCO licensing, we offer:

• End-to-end regulatory strategy and documentation support
• Assistance in preparing Device and Plant Master Files
• Coordination with testing laboratories and notified bodies
• Training on compliance and audit preparedness

Our expertise can significantly reduce time and avoid costly errors in your Oxygen Administration Hood licensing journey.

Getting Started with Your CDSCO License Application for Oxygen Administration Hood

1. Evaluate Your Device Classification: Confirm Class A status and licensing pathway.

2. Register on the CDSCO MD Online Portal: Create your account at the CDSCO MD Online Portal to initiate applications.

3. Prepare Documentation: Begin compiling all required documents, including technical files and quality system records.

4. Apply for Test License (MD13): Submit your test license application to commence manufacturing for testing.

5. Schedule Product Testing: Coordinate with approved labs early to avoid bottlenecks.

6. Engage a Notified Body: Choose from the list of notified bodies for your audit.

7. Plan for Audit and Compliance: Ensure your facility and processes are audit-ready.

8. Submit MD5 License Application: After successful testing and audit, apply for the manufacturing license.

By following these actionable steps and leveraging expert guidance, manufacturers can efficiently navigate the CDSCO regulatory landscape and bring their Oxygen Administration Hood to the Indian market with confidence.