CDSCO License for Cerebral oximeter

Introduction to Cerebral Oximeter and Its Regulatory Importance

A cerebral oximeter is a vital respiratory medical device designed to monitor regional hemoglobin oxygen saturation in the brain. It serves as an adjunct tool during surgeries or critical care to provide real-time oxygenation status, enabling timely clinical decisions. Given its critical role in patient safety, regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) is mandatory for manufacturers and importers aiming to market cerebral oximeters in India.

With over 25 years of expertise, we have successfully guided more than 500 companies through the CDSCO licensing process, ensuring smooth market entry and compliance.

CDSCO Regulatory Framework for Cerebral Oximeters

Under the Medical Devices Rules, 2017, cerebral oximeters fall under the "Respiratory" category and are classified as Class B (low-moderate risk). This risk classification dictates specific regulatory pathways, documentation, and audit requirements. The relevant notification for this device is File No. 29/Misc/03/2020-DC(197), dated 6.8.2021, which confirms the device's categorization.

Risk Classification and License Requirements for Class B Devices

Class B medical devices require an MD5 manufacturing license granted by the State Licensing Authority. This process involves multiple steps including a test license, product testing, audit by a notified body, and final license issuance. For cerebral oximeters:

• License Type: MD5 (Manufacturing License for Class A and B devices)
• Application Form: MD3
• Regulatory Authority: State Licensing Authority
• Total Processing Time: Approximately 3 to 4 months
• Applicable Fees: Rs 5000 per application + Rs 500 per product

For detailed classification guidance, manufacturers can refer to our Medical Device Classification resource.

Manufacturing License Process (MD5) for Cerebral Oximeters

1. Test License Application (Form MD13): This initial step grants permission to manufacture the device for testing purposes. It typically takes 1.5 to 2 months to obtain.
2. Product Testing: Samples must be tested at CDSCO-approved laboratories to verify compliance with Indian standards. Refer to the Testing Laboratories list for authorized facilities.
3. Document Compilation: Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.
4. Application Submission: Submit the MD5 application via the CDSCO MD Online Portal using Form MD3.
5. Audit by Notified Body: An audit of manufacturing premises and quality systems is conducted by a notified body. Check the list of notified bodies accredited for MD5 audits.
6. Query Resolution: Address any observations or queries raised by CDSCO or the notified body promptly to avoid delays.
7. License Grant: Upon satisfactory compliance, the State Licensing Authority issues the MD5 license.

For an in-depth understanding, our MD5 License Guide offers step-by-step instructions.

Manufacturing License Documents Required for Cerebral Oximeters

To streamline your application, ensure you have the following documents ready:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) – detailing device specifications and design controls (Device Master File Guide)
• Plant Master File (PMF) – describing manufacturing processes and facility (Plant Master File Guide)
• Essential Principles Checklist addressing compliance with Indian regulations
• Risk Management File illustrating hazard analysis and mitigation (Risk Management)
• Test Reports from CDSCO-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents, preferably ISO 13485:2016 certification

Import License Process (MD15) for Cerebral Oximeters

For importers, the MD15 license is mandatory, issued by the Central Licensing Authority. The process takes approximately 5 to 6 months and does not require a test license. Steps include:

• Preparation of documentation including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device Master File, Plant Master File, Wholesale License, and Company Constitution.
• Submission of Form MD14 via the CDSCO MD Online Portal.
• Resolution of any queries raised.
• Final license issuance.

Government fees for Class B imported devices are Rs 1,50,000 per site and Rs 1,00,000 per product approximately.

For detailed guidance, refer to our Import License Guide.

Import License Documents Required

• Valid Manufacturing License from country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution

Timeline and Processing Duration

Total time for MD5 license: Approximately 3 to 4 months.

Government Fees and Costs

• MD5 License Application Fee: Rs 5000 per application
• Per Product Fee: Rs 500
• Test License Fee (MD13): Typically included in application
• Additional Costs: Laboratory testing fees, audit fees charged by notified bodies (varies)

Budget realistically for approximately Rs 1,00,000 to Rs 1,50,000 covering all fees and incidental expenses.

Common Challenges and Solutions

• Delayed Test Reports: Plan sample submission early and choose reputed CDSCO-approved labs. Prioritize labs listed on the Testing Laboratories portal.
• Incomplete Documentation: Use comprehensive checklists, such as our Device Master File and Plant Master File guides, to ensure all documents meet CDSCO standards.
• Audit Non-compliance: Engage notified bodies early and conduct internal pre-audits to identify gaps.
• Query Handling: Respond to CDSCO queries promptly with detailed explanations and additional data if required.

Expert Consultation and Support

Navigating CDSCO licensing for cerebral oximeters can be complex. With our experience assisting over 500 companies, we offer tailored consulting services including document preparation, audit readiness, and application submission support. Our experts stay updated on regulatory changes to safeguard your timelines and approvals.

Getting Started with Your CDSCO License Application

1. Assess Your Device Class: Confirm your cerebral oximeter’s Class B status and licensing route.
2. Register on the CDSCO MD Online Portal: This is mandatory for all applications.
3. Apply for Test License (MD13): Initiate the process to manufacture samples for testing.
4. Select Accredited Testing Laboratory: Submit samples promptly to avoid delays.
5. Prepare Complete Documentation: Utilize our Device and Plant Master File guides and risk management resources.
6. Engage a Notified Body Early: Schedule your audit to align with your application timeline.
7. Submit MD5 Application (Form MD3): Upload all documents via the portal.
8. Track Application Status: Monitor progress and respond swiftly to queries.

Embarking on your CDSCO licensing journey with a clear roadmap ensures compliance and market readiness. Contact us to leverage our 25+ years of regulatory expertise and secure your cerebral oximeter’s place in the Indian healthcare market efficiently.