CDSCO License for Oxygen breath analyser

Comprehensive CDSCO Licensing Guide for Oxygen Breath Analyser (Class C Medical Device)

As specialists with over 25 years of experience and having successfully guided more than 500 companies through the CDSCO licensing maze, we understand the critical importance of obtaining the correct regulatory approvals for your medical devices. The Oxygen Breath Analyser, classified as a Class C device under Indian regulations, plays a pivotal role in pediatric and neonatology pulmonary diagnostics. Ensuring compliance with CDSCO’s stringent framework not only smooths your device’s entry into the Indian market but also builds credibility and trust among healthcare providers.

Understanding the Oxygen Breath Analyser and Its Regulatory Significance

The Oxygen Breath Analyser is an AC-powered laboratory instrument designed for intermittent or periodic measurement of oxygen in respiratory gas specimens. Used extensively in pulmonary function tests and critical care scenarios—especially for neonates and infants—this device’s accuracy and safety are paramount. Given its risk classification as Class C, it falls under moderate to high-risk devices, necessitating central licensing authority approval from the CDSCO.

CDSCO Regulatory Framework for Oxygen Breath Analyser (Class C Device)

India’s regulatory framework for medical devices is governed by the Medical Device Rules (MDR) 2017, with oversight by the Central Drugs Standard Control Organization (CDSCO). For Class C devices such as the Oxygen Breath Analyser, the CDSCO’s Central Licensing Authority (CLA) handles licensing, inspection, and post-market surveillance. Compliance ensures your device meets the Essential Principles of Safety and Performance and aligns with international standards such as ISO 13485.

Risk Classification and Licensing Requirements for Class C Devices

Class C devices are moderate to high risk and require an MD9 manufacturing license from the CDSCO Central Licensing Authority. If you are importing this device, an MD15 import license is mandatory. The detailed classification can be verified via our Medical Device Classification resource.

Manufacturing License Process (MD9) for Oxygen Breath Analyser

Obtaining an MD9 license involves a multi-step process:

1. Test License (Form MD13): Initially, you must apply for a test license, valid for 6 months, allowing you to manufacture the device for testing. This stage typically takes 1.5 to 2 months.

2. Product Testing: Conduct mandatory product testing at government-approved laboratories. Refer to the Testing Laboratories list for certified labs.

3. Documentation Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.

4. Application Submission (Form MD7): Submit your MD9 manufacturing license application via the CDSCO MD Online Portal.

5. Audit and Inspection: CDSCO inspectors conduct audits to verify compliance. This may take up to 1 month.

6. Query Resolution: Address any queries raised by CDSCO during the review.

7. License Grant (Form MD9): Post successful audit and resolution, the manufacturing license is granted.

The entire process generally spans 4 to 5 months.

For detailed guidance, explore our MD9 License Guide.

Manufacturing License Documents Required for MD9

For your Oxygen Breath Analyser, the following documents must accompany your application:

• Company Constitution (Incorporation Certificate, MOA/AOA)
• Proof of ownership/lease of manufacturing premises
• Details of qualified technical staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) detailing design, specifications, and manufacturing process (Device Master File Guide)
• Plant Master File (PMF) describing manufacturing infrastructure (Plant Master File Guide)
• Essential Principles Checklist
• Risk Management File (Risk Management resource)
• Test Reports from approved labs
• Product labels and Instructions for Use (IFU)
• Quality Management System documents (ISO 13485 certification)

Import License Process (MD15) for Oxygen Breath Analyser

If you plan to import the Oxygen Breath Analyser, an MD15 import license is mandatory. The process includes:

• Preparation of required documents, including existing manufacturing license, Free Sale Certificate, CE Certificate, ISO 13485:2016 certification, and device technical files.
• Application submission on the CDSCO MD Online Portal.
• Resolution of any CDSCO queries.
• License issuance.

The import license typically takes 5 to 6 months to obtain.

For more details, consult our Import License Guide.

Import License Documents Required for MD15

Key documents for import license include:

• Valid manufacturing license (MD9 or equivalent)
• Free Sale Certificate from country of origin
• ISO 13485:2016 certification
• CE Certificate or equivalent
• Device Master File
• Plant Master File
• Wholesale Drug License
• Company Constitution

Timeline and Processing Duration Summary

Government Fees and Costs

Budget for additional costs related to testing, audits by CDSCO inspectors, and consultancy support.

Common Challenges and Practical Solutions

• Delays in Test License Approval: Pre-empt by submitting complete and accurate documentation with your MD13 application.

• Product Testing Failures: Choose testing labs with proven expertise in respiratory gas analyzers; conduct internal pre-testing.

• Audit Non-compliance: Maintain a robust QMS and prepare your team for CDSCO audits by conducting mock audits.

• Query Resolution Delays: Respond promptly and provide clear, supported evidence to CDSCO queries to avoid procedural bottlenecks.

Expert Consultation and Support

With our extensive experience in navigating CDSCO regulations for devices like the Oxygen Breath Analyser, we provide end-to-end support — from document preparation to audit readiness and application follow-up. Our expertise ensures you avoid common pitfalls and accelerate your path to license grant.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm the Oxygen Breath Analyser’s Class C status by referring to the Medical Device Classification guidelines.

2. Prepare Your Documentation: Begin compiling your Device Master File, Plant Master File, and Risk Management File using our detailed guides.

3. Apply for Test License (MD13): Submit your application on the CDSCO MD Online Portal to commence manufacturing for testing.

4. Schedule Product Testing: Coordinate with approved testing laboratories to conduct mandated evaluations.

5. Submit MD9 Application: Once testing is complete, upload your documents and apply for the manufacturing license.

6. Prepare for Audit: Engage with notified bodies and CDSCO inspectors to ensure smooth audits.

7. Plan Import Licensing if Applicable: If importing, start compiling import license documents early to align with manufacturing license timelines.

Embarking on the CDSCO licensing journey for your Oxygen Breath Analyser is complex but manageable with the right expertise and preparation. We encourage manufacturers and importers to leverage our proven strategies and comprehensive regulatory knowledge to achieve successful registration and market access in India.