CDSCO License for Oxygen/air breathing gas mixer

Oxygen/Air Breathing Gas Mixer: Regulatory Overview and Importance

Oxygen/air breathing gas mixers are critical medical devices in anesthesiology, designed to blend ambient air and oxygen to deliver precise oxygen concentrations during first aid or emergency interventions. As a portable mechanical device for mobile O2 administration, its reliability directly impacts patient safety. Given the device's classification as Class B under CDSCO regulations, adherence to regulatory compliance is essential to ensure quality, safety, and market access in India.

At our consultancy, with over 25 years of experience and having supported more than 500 companies, we understand the nuances involved in securing CDSCO licenses. This comprehensive guide focuses on the regulatory framework, application process, timelines, costs, and documentation specifically for Oxygen/Air Breathing Gas Mixers.

CDSCO Regulatory Framework for Oxygen/Air Breathing Gas Mixers

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules, 2017. Devices are classified into Classes A, B, C, and D based on risk, with Class B devices considered low to moderate risk. Oxygen/air breathing gas mixers fall under Class B due to their intended use in emergency and anesthesiology settings.

Compliance with CDSCO ensures that the device meets Indian safety and performance standards, enabling manufacturers and importers to legally market these products. Non-compliance can lead to regulatory actions, including product recalls and legal penalties.

Risk Classification and License Requirements

Risk Class: B

As a Class B device, the Oxygen/Air Breathing Gas Mixer requires a manufacturing license under the MD5 category. This license is granted by the State Licensing Authority and involves a multi-step process, including obtaining a test license, product testing, documentation, audit by a notified body, and final license approval.

Manufacturers and importers must familiarize themselves with the medical device classification criteria to confirm their device's classification and corresponding regulatory requirements.

Manufacturing License Process (MD5)

The manufacturing license for Class B devices is processed via Form MD3 on the CDSCO MD Online Portal. The sequence is as follows:

1. Test License (Form MD13): Required initially to manufacture and test the device samples. This stage takes approximately 1.5 to 2 months.
2. Product Testing: Conducted by government-approved laboratories to validate device safety and performance.
3. Documentation Preparation: Comprehensive preparation of technical and quality documents.
4. License Application (Form MD3): Application for the MD5 manufacturing license.
5. Audit: Conducted by a notified body from the list of notified bodies authorized to audit Class B devices.
6. Queries Resolution: Addressing any observations from the audit or CDSCO.
7. Grant of License (Form MD5): Upon satisfactory compliance, the license is issued.

For detailed procedural guidance, refer to our MD5 License Guide.

Manufacturing License Documents Required

Successful application hinges on thorough documentation. For the Oxygen/Air Breathing Gas Mixer, the following are essential:

• Company Constitution Documents: Proof of incorporation, partnership deed, or proprietorship documents.
• Proof of Ownership of Premises: Rent agreement or ownership proof.
• Technical Staff Documentation: Qualification and experience certificates of technical personnel.
• Fire NOC and Pollution Control Certificate: Compliance with local safety norms.
• Device Master File (DMF): Detailed design and manufacturing process documentation. Our Device Master File Guide provides a stepwise approach.
• Plant Master File (PMF): Description of manufacturing facilities and quality systems, see our Plant Master File Guide.
• Essential Principles Checklist: Compliance matrix with Indian standards.
• Risk Management File: As per ISO 14971 standards, addressing device-specific risks. Learn more on implementing risk management.
• Test Reports: From CDSCO-approved testing laboratories. Refer to the Testing Laboratories list.
• Labels and Instructions for Use (IFU): In compliance with CDSCO labeling requirements.
• Quality Management System (QMS) Documents: ISO 13485 certification and related SOPs.

Import License Process (MD15)

If you plan to import Oxygen/Air Breathing Gas Mixers, the import license process is governed by the MD15 license, issued by the Central Licensing Authority on Form MD14.

The process involves:

1. Document Preparation: Including manufacturing license from the country of origin, Free Sale Certificate, CE certificate, and QMS certifications.
2. Application Submission: Via the CDSCO MD Online Portal.
3. Queries Resolution: Address any concerns raised by CDSCO.
4. Grant of License: Typically within 5-6 months.

For detailed insights, consult our Import License Guide.

Import License Documents Required

Key documents include:

• Valid manufacturing license from the country of origin.
• Free Sale Certificate.
• ISO 13485:2016 certification.
• CE Certificate or equivalent.
• Device Master File and Plant Master File.
• Wholesale license of the importer.
• Company incorporation documents.

Timeline and Processing Duration

Note: Timelines may vary depending on the completeness of documents and audit scheduling.

Government Fees and Costs

For a Class B Oxygen/Air Breathing Gas Mixer, the fees for manufacturing license (MD5) are as follows:

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

These fees are payable through the CDSCO MD Online Portal during application submission.

Additional costs include:

• Testing fees charged by government-approved laboratories.
• Audit fees payable to notified bodies.
• Consulting and documentation preparation fees (varies by service provider).

For a detailed cost breakdown, our MD5 guide provides practical estimations.

Common Challenges and Solutions

Challenge 1: Delayed Test License Approval

• Solution: Submit a complete and accurate application with all required documents to avoid back-and-forth.

Challenge 2: Product Testing Delays

• Solution: Engage with CDSCO-approved testing laboratories early and schedule tests proactively.

Challenge 3: Audit Non-compliance Findings

• Solution: Conduct internal pre-audits and ensure QMS and documentation are audit-ready.

Challenge 4: Query Resolution Delays

• Solution: Assign dedicated personnel to respond promptly with evidence-based replies.

Challenge 5: Labeling and IFU Non-conformities

• Solution: Follow CDSCO guidelines strictly and consult experts for label review.

Expert Consultation and Support

Navigating the CDSCO licensing process can be complex. Our team of regulatory experts offers:

• End-to-end support from documentation to audit readiness.
• Customized regulatory strategy based on device risk and intended use.
• Assistance with liaisoning with CDSCO and notified bodies.
• Training on risk management and quality systems.

Our track record includes successful MD5 license approvals for over 500 medical device manufacturers, including oxygen/air mixers.

Getting Started with Your CDSCO License Application

1. Confirm Device Classification: Verify your Oxygen/Air Breathing Gas Mixer is Class B via the official CDSCO classification lists or our Medical Device Classification resource.
2. Prepare Documentation: Begin compiling all required files, including DMF, PMF, risk management, and QMS documents.
3. Engage a CDSCO-Approved Testing Laboratory: Schedule your product testing early.
4. Apply for Test License (MD13): Submit through the CDSCO MD Online Portal.
5. Plan Audit with Notified Body: Choose from the list of notified bodies authorized for Class B devices.
6. Submit Manufacturing License Application (MD5): Once test license and testing are complete.
7. Respond to Queries Promptly: Maintain clear communication with CDSCO and notified bodies.

Embarking on the CDSCO licensing journey with expert guidance ensures a smoother process and timely market entry. Contact us today to initiate your Oxygen/Air Breathing Gas Mixer license application and leverage our specialized regulatory expertise.