CDSCO License for Intravascular oximeter

Introduction to Intravascular Oximeter and Regulatory Importance

The intravascular oximeter is a critical anesthesiology device designed for the continuous in vivo measurement of venous blood oxygen saturation (SvO2) via a fibreoptic catheter. This sophisticated medical technology plays a vital role in monitoring patient oxygenation status during surgeries and critical care, making its safe and effective performance paramount.

Given the device’s clinical significance and patient safety implications, regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) in India is mandatory before manufacturing or marketing. Ensuring a CDSCO license not only facilitates legal market entry but also builds trust with healthcare providers and patients.

CDSCO Regulatory Framework for Intravascular Oximeter

Intravascular oximeters fall under the medical device category regulated by CDSCO, India’s national regulatory authority responsible for overseeing medical devices’ safety, efficacy, and quality. Since the device is classified under anesthesiology and carries moderate risk, it must adhere to the regulatory framework established in the Medical Device Rules (MDR), 2017, aligned with the Drugs and Cosmetics Act.

Specifically, the device is categorized as Class B, signifying low to moderate risk, which influences the licensing authority, documentation, and audit requirements.

Risk Classification and License Requirements

According to the Medical Device Classification guidelines:

• Device Risk Class: B (Low-Moderate Risk)
• Regulatory License Type: MD5 Manufacturing License
• Approving Authority: State Licensing Authority

Class B devices require obtaining an MD5 license, applied through Form MD3, after successfully completing a test license phase and product testing.

Manufacturing License Process (MD5) for Class B Intravascular Oximeter

The MD5 license process encompasses several critical steps:

1. Test License Application (Form MD13): Before manufacturing, you must secure a test license, allowing pilot manufacturing for sample testing. This step typically takes 1.5 to 2 months.

2. Product Testing: Samples must be tested in CDSCO-approved government laboratories. Testing duration varies depending on the device complexity but usually spans 4 to 6 weeks.

3. Documentation Preparation: Compile comprehensive technical files, including Device Master File, Plant Master File, Risk Management File, and QMS documentation.

4. MD5 License Application (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.

5. Audit by Notified Body: A state-appointed notified body will conduct a detailed factory audit. Find the list of notified bodies here.

6. Queries and Resolution: Address any audit or CDSCO queries promptly.

7. Grant of MD5 License: Upon satisfactory compliance, CDSCO issues the MD5 license, authorizing commercial manufacturing.

The entire MD5 license process typically spans 3 to 4 months after initiating the test license.

Manufacturing License Documents Required

For the intravascular oximeter Class B device, the following documents must be meticulously prepared and submitted:

• Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Technical Staff Details and Qualifications
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF) – detailing design, specifications, and manufacturing processes (Device Master File guide)
• Plant Master File (PMF) – outlining manufacturing facilities and quality systems (Plant Master File guide)
• Essential Principles Checklist ensuring compliance with safety and performance standards
• Risk Management File highlighting hazard analysis and mitigation strategies (Risk Management insights)
• Test Reports from CDSCO-approved laboratories (Testing Laboratories list)
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation compliant with ISO 13485:2016

Import License Process (MD15) for Intravascular Oximeter

If you are an importer intending to bring the intravascular oximeter into India, the MD15 import license is mandatory. The process includes:

1. Document preparation, including manufacturing license from the country of origin, Free Sale Certificate, CE Certificate, ISO 13485:2016 certification, and other technical files.

2. Submission of application on Form MD14 via the CDSCO MD Online Portal.

3. Review by the central licensing authority, addressing queries.

4. Grant of MD15 license allowing lawful import.

This process generally takes 5 to 6 months.

Import License Documents Required

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

Timeline and Processing Duration

Total manufacturing license acquisition time is approximately 3 to 4 months post test license issuance.

For import license (MD15), expect 5 to 6 months.

Government Fees and Costs

For the intravascular oximeter (Class B device), the fees are as follows:

• MD5 License: Rs 5,000 per application + Rs 500 per product
• Test License (MD13): Included within the MD5 process

Additional costs to consider:

• Testing fees at government-approved laboratories
• Audit fees by notified bodies
• Consultancy fees if engaging experts

Planning finances ahead of application submission is critical to avoid delays.

Common Challenges and Solutions

Challenge 1: Delayed Test Reports

• Solution: Engage early with CDSCO-approved testing labs and submit samples promptly.

Challenge 2: Incomplete Documentation

• Solution: Use checklists and expert templates for Device Master File and Plant Master File to ensure completeness.

Challenge 3: Audit Non-compliance

• Solution: Conduct internal mock audits and staff training before notified body visits.

Challenge 4: Slow Query Resolution

• Solution: Respond comprehensively and promptly to CDSCO queries; maintain open communication.

Expert Consultation and Support

With over 25 years of experience assisting 500+ medical device companies, we offer end-to-end support, including:

• Gap analysis and readiness assessment
• Documentation preparation and review
• Liaison with CDSCO and notified bodies
• Training for internal teams on compliance

Our expertise ensures smoother, faster approvals and regulatory peace of mind.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your intravascular oximeter’s Class B risk status using the Medical Device Classification guide.

2. Begin Test License Application: Prepare and submit Form MD13 via the CDSCO MD Online Portal to get started.

3. Initiate Product Testing: Coordinate with CDSCO-approved testing laboratories early to avoid bottlenecks.

4. Compile Technical Documentation: Use our detailed guides on Device Master File and Plant Master File to ensure compliance.

5. Plan for Audit: Schedule and prepare for the notified body audit using the list of notified bodies.

6. Submit MD5 License Application: After successful testing and documentation, submit Form MD3 and manage queries diligently.

7. Leverage Expert Help: Contact us to navigate complexities and accelerate your CDSCO licensing journey.

By following these actionable steps and leveraging proven expertise, manufacturers and importers can confidently bring their intravascular oximeters into the Indian market, ensuring compliance, safety, and commercial success.