CDSCO License for Analyzing software for hemodynamics or cardiac function

Understanding CDSCO Licensing for Analyzing Software for Hemodynamics or Cardiac Function

As a specialized software medical device designed to analyze hemodynamics or cardiac function, your product plays a crucial role in aiding diagnosis by processing diagnostic imaging data. Given the sensitive nature of cardiac diagnostics, regulatory compliance under the Central Drugs Standard Control Organisation (CDSCO) is mandatory before marketing in India. With over 25 years of experience assisting 500+ companies in obtaining CDSCO licenses, we understand the nuances involved in securing approvals for Class B medical device software like yours.

CDSCO Regulatory Framework for Software Medical Devices

Medical device software, including those analyzing cardiac function, is regulated under the Medical Devices Rules, 2017, enforced by CDSCO. Your device is classified as Class B, which means it carries a moderate risk level requiring a structured compliance pathway. The applicable notification – 29/Misc./03/2020-DC (198) dated 13.9.2021 – recognizes such software under CDSCO’s purview, emphasizing the need for rigorous validation, quality management, and risk mitigation before approval.

Risk Classification and License Requirements for Class B Software

Class B devices are medium-risk devices that require a manufacturing license under Form MD5 issued by the State Licensing Authority. As your product is software for hemodynamic analysis, it falls squarely under this category, and you must adhere to the MD5 licensing pathway. This includes obtaining a test license (Form MD13) first, followed by product testing, audit by a notified body, and final license grant.

You can learn more about medical device classification to understand how CDSCO categorizes software-based devices.

Manufacturing License Process (MD5) for Class B Medical Device Software

The MD5 license process for your cardiac function analyzing software involves several critical steps:

1. Apply for Test License (Form MD13): This initial step authorizes you to manufacture the software prototype for testing purposes. It typically takes 1.5 to 2 months to obtain.

2. Product Testing: The software must be tested for compliance with Indian standards at CDSCO-approved labs. For software, testing focuses on functional validation, performance, and risk management. Refer to the list of testing laboratories for accredited facilities.

3. Document Preparation: Comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), risk management files, and essential principles checklists must be prepared. Our detailed Device Master File guide and Plant Master File guide can assist you in compiling these.

4. Apply for Manufacturing License (Form MD3): Submit your application on the CDSCO MD Online Portal, including all required documents.

5. Audit by Notified Body: A notified body, selected from the CDSCO notified bodies list, will conduct an on-site audit of your manufacturing facility and quality management system.

6. Query Resolution: Address any queries raised by CDSCO or the notified body promptly to avoid delays.

7. License Grant: Upon successful audit and document review, CDSCO will issue the MD5 license in Form MD5.

Manufacturing License Documents Required for Class B Software

For your hemodynamics analysis software, prepare the following essential documents:

• Company Constitution and Incorporation Certificate
• Proof of ownership or lease agreement of manufacturing premises
• Details and qualifications of technical staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing software architecture, algorithms, validation protocols
• Plant Master File (PMF) outlining manufacturing processes and quality controls
• Essential Principles Checklist aligned to Medical Device Rules
• Risk Management File documenting hazard identification and mitigation per risk management best practices
• Test Reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU) compliant with Indian regulations
• Quality Management System (QMS) documentation, preferably ISO 13485 certified

Import License Process (MD15) for Software Medical Devices

If you plan to import your software device, an MD15 Import License issued by the Central Licensing Authority is mandatory. The process involves:

• Document preparation including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate if applicable
• Submission of application on the CDSCO MD Online Portal
• Resolution of departmental queries
• License grant typically within 5-6 months

Refer to our comprehensive Import License guide for detailed insights.

Import License Documents Required

Key documents include:

• Valid Manufacturing License from the exporting country
• Free Sale Certificate
• ISO 13485:2016 certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License if applicable
• Company Constitution and Registration Certificates

Timeline and Processing Duration

• Test License (MD13): 1.5 to 2 months
• Product Testing: 1 to 1.5 months (varies by lab workload)
• Document Preparation: Concurrent with testing, around 1 month
• Audit by Notified Body: Scheduled within 1 month post document submission
• Query Resolution: 2 to 4 weeks depending on complexity
• Final License Grant (MD5): Total process approximately 3 to 4 months

Being proactive in documentation and rapid response to queries significantly streamlines the timeline.

Government Fees and Costs

For your Class B software device:

• Test License Fee (MD13): Approximately Rs. 5,000
• Manufacturing License Fee (MD5): Rs. 5,000 per application
• Product Fee: Rs. 500 per product
• Notified Body Audit Fees: Varies, typically Rs. 50,000 to Rs. 1,00,000 depending on scope
• Product Testing Charges: Varies by laboratory and test complexity

Budget approximately Rs. 1,00,000 to Rs. 1,50,000 for the entire licensing process excluding internal resource costs.

Common Challenges and Solutions

• Challenge: Delays in audit scheduling by notified bodies.

  • Solution: Early engagement with notified bodies and booking audit dates in advance.

• Challenge: Incomplete or inconsistent documentation leading to queries.

  • Solution: Use detailed checklists and templates from our Device Master File guide to ensure completeness.

• Challenge: Lack of clarity on product testing scope for software.

  • Solution: Collaborate closely with CDSCO-approved testing labs to define test protocols upfront.

• Challenge: Extended query resolution timelines.

  • Solution: Maintain a dedicated regulatory liaison to respond promptly and comprehensively.

Expert Consultation and Support

Navigating CDSCO licensing for specialized Class B software devices demands expertise and experience. Our team has successfully guided over 500 companies through this process. We offer tailored consultation services including:

• Regulatory strategy development
• Documentation preparation and review
• Coordination with notified bodies and testing labs
• Training on compliance and quality management

Partnering with experts reduces risk, accelerates timelines, and ensures compliance.

Getting Started with Your CDSCO License Application

1. Evaluate Your Device Classification: Confirm Class B status and regulatory requirements.

2. Register on CDSCO MD Online Portal: Create your account at the CDSCO MD Online Portal to initiate applications.

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

4. Apply for Test License (Form MD13): Submit your application promptly to start the clock on your licensing timeline.

5. Engage with Approved Testing Labs: Schedule testing as soon as you receive the test license.

6. Select a Notified Body: Choose from the official list of notified bodies and schedule your audit.

7. Prepare for Audit: Ensure your QMS and documentation are audit-ready.

8. Submit Manufacturing License Application (Form MD3): Once testing and audit preparations are complete, file your application.

By following these practical steps with our expert support, you can efficiently secure your CDSCO license and bring your innovative cardiac function analyzing software to the Indian market with confidence.