CDSCO License for Non-rebreathing oxygen face mask

Introduction to Non-rebreathing Oxygen Face Masks and CDSCO Licensing Importance

Non-rebreathing oxygen face masks are critical anesthesiology devices designed to deliver high concentrations of oxygen directly to patients’ airways while preventing rebreathing of exhaled gases. With increasing demand across hospitals and critical care units, ensuring regulatory compliance under India’s Central Drugs Standard Control Organization (CDSCO) framework is essential for manufacturers and importers aiming to supply this device. Proper licensing not only affirms product safety and efficacy but also facilitates market access and builds trust among healthcare providers.

CDSCO Regulatory Framework for Non-rebreathing Oxygen Face Masks

This device falls under the anesthesiology category and is notified under CDSCO Notification 29/Misc/03/2020-DC(177) dated 12.07.2021. Classified as a Class A medical device (low risk), it is regulated under the Medical Device Rules, 2017. For Class A devices, the state licensing authority issues the manufacturing license (MD5), streamlining the process while maintaining stringent quality and safety checks.

Risk Classification and License Requirements for Class A Devices

As a Class A device, the non-rebreathing oxygen face mask requires an MD5 manufacturing license. This entails compliance with all essential principles regarding design, manufacturing, labeling, and post-market surveillance. Importers and manufacturers must also secure a test license (MD13) before applying for the MD5 license, ensuring that the device meets Indian standards through government-approved laboratory testing.

For a detailed understanding of device classification, manufacturers can refer to the Medical Device Classification guide.

Manufacturing License Process (MD5) for Non-rebreathing Oxygen Face Masks

1. Apply for Test License (Form MD13): Initiate by submitting an application for a test license on the CDSCO MD Online Portal. This allows product testing at government-approved labs.
2. Product Testing: Submit samples to laboratories listed by CDSCO to verify compliance with specifications. The list of testing laboratories is available online.
3. Prepare Required Documents: Compile technical and quality documentation, including Device Master File, Plant Master File, risk management file, and QMS documents.
4. Submit Application for MD5 License (Form MD3): After receiving test reports, apply for the manufacturing license through the CDSCO MD Online Portal.
5. Audit by Notified Body: The state authority appoints a notified body from the official Notified Bodies List to conduct an onsite audit of manufacturing facilities and compliance.
6. Resolve Queries: Respond to any department or notified body queries promptly.
7. Grant of MD5 License: Upon satisfactory review and audit, the license is granted on Form MD5.

Manufacturing License Documents Required

For a smooth application, ensure the following documents are ready:

• Company Constitution/Registration Proof
• Proof of ownership or lease of manufacturing premises
• Qualifications and experience details of technical staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (design and technical specifications) – see our comprehensive Device Master File guide
• Plant Master File detailing manufacturing processes – learn more from our Plant Master File guide
• Essential Principles Checklist demonstrating compliance
• Risk Management File per ISO 14971 principles (Risk Management guide)
• Test Reports from government-approved labs
• Labeling and Instructions for Use (IFU)
• Quality Management System (QMS) documents aligned with ISO 13485

Import License Process (MD15) for Non-rebreathing Oxygen Face Masks

If you plan to import this device into India, an MD15 import license from the Central Licensing Authority is required. The process includes:

1. Document Preparation: Assemble manufacturing license, free sale certificate, CE certificate (if applicable), ISO 13485:2016 certification, Device and Plant Master Files, wholesale license, and company constitution.
2. Submit Application (Form MD14): File the import license application through the CDSCO MD Online Portal.
3. Respond to Queries: Timely address any department queries.
4. Grant of MD15 License: Upon approval, the import license is issued.

For a comprehensive overview, refer to our Import License guide.

Import License Documents Required

• Valid manufacturing license for the device
• Free Sale Certificate from the country of origin
• ISO 13485:2016 certification
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale drug license for import
• Company Constitution and registration details

Timeline and Processing Duration

• Test License (MD13): Approximately 1.5 to 2 months
• Product Testing: 1 to 2 months depending on lab workload
• MD5 Manufacturing License: 3 to 4 months post test license, including audit and query resolution

Overall, manufacturers should anticipate a total duration of 3 to 4 months to obtain the MD5 license for a Class A device like the non-rebreathing oxygen face mask.

Government Fees and Costs

• Test License Fee: Included in the total process
• MD5 License Fees: Rs. 5,000 per application plus Rs. 500 per product

Budgeting for additional costs such as notified body audits, laboratory testing fees, and document preparation is essential to avoid delays.

Common Challenges and Solutions

• Delays in Product Testing: Government labs may face backlogs; consider early sample submission and confirm timelines.
• Incomplete Documentation: Meticulously prepare and cross-check required files to avoid rejection.
• Audit Non-compliance: Ensure manufacturing sites strictly comply with Good Manufacturing Practices (GMP) before audit.
• Query Resolution Delays: Assign a dedicated regulatory liaison to respond promptly to CDSCO and notified body queries.

Our experience with over 500 companies shows that proactive planning and expert guidance drastically reduce processing times and improve approval success rates.

Expert Consultation and Support

Navigating CDSCO licensing for medical devices, even Class A low-risk devices, requires detailed knowledge of regulatory nuances. We offer end-to-end support from test license application to audit readiness and final license grant. Leveraging our expertise ensures your non-rebreathing oxygen face mask complies fully with Indian regulations and reaches market without avoidable hurdles.

Getting Started with Your CDSCO License Application

1. Register on the CDSCO MD Online Portal.
2. Initiate your test license (MD13) application immediately to account for testing time.
3. Simultaneously, start compiling detailed technical documentation and quality system files.
4. Engage with notified bodies early to schedule audits post-document submission.
5. Plan your timelines realistically, factoring in possible queries and re-submissions.

By following these actionable steps and leveraging our 25+ years of specialized regulatory consulting, your journey to obtaining the CDSCO MD5 license for your non-rebreathing oxygen face mask will be efficient and compliant.

For further assistance, detailed templates, and tailored support, contact us to accelerate your regulatory approval process.