CDSCO License for Foetal pulse oximeter

Comprehensive Guide to CDSCO Licensing for Foetal Pulse Oximeter (Class B Medical Device)

As a specialized respiratory medical device, the Foetal Pulse Oximeter plays a critical role in intrapartum monitoring by measuring foetal oxygen saturation (FSpO2) during labor, especially when abnormal foetal heart rate patterns are observed. Given its significance in clinical decision-making, regulatory compliance with the Central Drugs Standard Control Organisation (CDSCO) in India is essential before marketing or manufacturing this device.

With over 25 years of experience and having guided 500+ companies through CDSCO licensing, we offer you a detailed roadmap tailored specifically for Class B medical devices like the Foetal Pulse Oximeter.

CDSCO Regulatory Framework for Foetal Pulse Oximeter

The Foetal Pulse Oximeter falls under the respiratory device category and is classified as a Class B medical device under the CDSCO framework. This classification aligns with moderate risk devices that require State Licensing Authority approval for manufacturing via the MD5 license.

The regulatory journey involves multiple stages, including obtaining a test license, product testing, documentation preparation, notified body audit, and finally, the grant of manufacturing license.

You must adhere to the CDSCO notification (File No. 29/Misc/03/2020-DC(197) dated 6.8.2021) and comply with the Medical Device Rules, 2017 amended as per recent updates.

Risk Classification and License Requirements

• Device Name: Foetal Pulse Oximeter
• Risk Class: B (Moderate Risk)
• License Required: MD5 Manufacturing License (Form MD3 application)
• Licensing Authority: State Licensing Authority

The Class B designation mandates an MD5 license to manufacture, which involves a comprehensive audit by a notified body and adherence to quality management standards.

For importers, the MD15 license from the Central Licensing Authority is required, but here we focus primarily on manufacturing licensing.

Manufacturing License Process (MD5) for Foetal Pulse Oximeter

1. Apply for Test License (Form MD13):

   • Duration: Approximately 1.5 to 2 months
   • Purpose: Allows you to manufacture the device for testing purposes

2. Product Testing:

   • Conduct product testing at CDSCO-recognized government-approved laboratories
   • Ensure test reports confirm compliance with applicable standards for respiratory devices and safety

3. Documentation Preparation:

   • Assemble your Device Master File, Plant Master File, Risk Management File, and other essential documents

4. Apply for MD5 License (Form MD3):

   • Submit your application through the CDSCO MD Online Portal

5. Notified Body Audit:

   • Engage a notified body from the CDSCO Notified Bodies List for a comprehensive facility and QMS audit

6. Query Resolution:

   • Address any queries raised by the licensing authority or notified body promptly

7. License Grant:

   • Upon satisfactory compliance, the State Licensing Authority will issue the MD5 license (Form MD5)

Manufacturing License Documents Required for Foetal Pulse Oximeter

• Company constitution documents (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of ownership or valid lease agreement for manufacturing premises
• Details and qualifications of technical staff
• No Objection Certificates (NOCs) for Fire Safety and Pollution Control
• Device Master File (DMF) detailing product specifications, design, and manufacturing process (Guide to Device Master File)
• Plant Master File (PMF) outlining manufacturing facility and equipment (Guide to Plant Master File)
• Essential Principles Checklist demonstrating compliance with safety and performance requirements
• Risk Management File complying with ISO 14971 standards (Risk Management Guidance)
• Product testing reports from CDSCO-approved labs (Testing Laboratories List)
• Labeling and Instructions for Use (IFU) documents adhering to CDSCO guidelines
• Quality Management System (QMS) documentation, preferably ISO 13485:2016 certification

Import License Process (MD15) for Foetal Pulse Oximeter

If you are importing the Foetal Pulse Oximeter into India, the MD15 import license issued by the Central Licensing Authority is mandatory.

Process Overview:

• Compile necessary documents including manufacturing license from country of origin, Free Sale Certificate, ISO 13485:2016, CE certificate, Device Master File, Plant Master File, and Wholesale License
• Apply online on the CDSCO MD Online Portal
• Respond to any queries raised during document scrutiny
• Await grant of MD15 license

Note: Unlike manufacturing, a test license is not required for import.

Import License Documents Required

• Manufacturing License issued by foreign regulatory authority
• Free Sale Certificate
• ISO 13485:2016 certificate
• CE Certificate or equivalent
• Device Master File
• Plant Master File
• Wholesale License valid in India
• Company constitution documents

Timeline and Processing Duration

For the Foetal Pulse Oximeter, the entire manufacturing licensing process typically spans around 3 to 4 months post test license issuance.

Government Fees and Costs

Additional costs include:

• Fees for product testing at government-approved labs
• Notified body audit charges (varies by notified body)
• Consultancy and documentation preparation fees, if outsourced

Common Challenges and Solutions

• Delays in Product Testing: Test laboratories can have backlogs; plan testing early and select labs from the CDSCO Testing Laboratories List.
• Incomplete Documentation: Meticulous preparation of Device Master File and Risk Management File is critical. Utilize comprehensive guides to avoid rejections.
• Audit Non-compliance: Ensure your QMS aligns with ISO 13485 and CDSCO requirements before audit.
• Query Resolution Delays: Assign a dedicated regulatory liaison to respond promptly to CDSCO queries.

Expert Consultation and Support

With over 25 years of experience and successful licensing for 500+ companies, we provide end-to-end support including:

• Gap assessment of existing documentation
• Device and Plant Master File preparation
• Risk management strategy implementation
• Coordination with notified bodies and labs
• Application submission and follow-up on CDSCO MD Online Portal

Our proven approach reduces licensing timelines and mitigates regulatory risks.

Getting Started with Your CDSCO License Application

1. Assess your device classification: Confirm your Foetal Pulse Oximeter as Class B using CDSCO guidelines (Medical Device Classification).

2. Prepare test license application (Form MD13): Collect essential documents and submit via the CDSCO MD Online Portal.

3. Identify government-approved testing laboratories: Schedule product testing early.

4. Engage a notified body: Select from the official Notified Bodies List to plan your audit.

5. Compile documentation: Use our Device Master File and Plant Master File guides as references.

6. Submit your MD5 license application (Form MD3): Once testing is complete and audit scheduled.

7. Maintain proactive communication: Respond promptly to CDSCO queries to avoid delays.

By following these practical steps and leveraging our expertise, manufacturers and importers of Foetal Pulse Oximeters can confidently navigate the CDSCO licensing process and access the Indian market efficiently.