CDSCO License for X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device

Introduction to X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device and Regulatory Importance

The X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device is a cutting-edge software tool designed to analyze coronary blood flow using X-ray angiographic imaging data. It provides simulation-based metrics that assist cardiologists in clinical decision-making, enhancing diagnostic accuracy and patient outcomes. As a Class B medical device software under CDSCO’s framework, it demands strict regulatory compliance to ensure safety, performance, and quality before entering the Indian market.

Navigating the regulatory landscape for such specialized software devices can be challenging. With over 25 years of experience and having guided 500+ companies through CDSCO licensing, we understand the nuances and critical steps involved. This comprehensive guide offers practical insights, timelines, costs, and documentation requirements specifically tailored for Class B software devices like this angiographic simulation tool.

CDSCO Regulatory Framework for Software-Based Medical Devices

India’s Central Drugs Standard Control Organization (CDSCO) governs the import and manufacture of medical devices, including software classified as medical devices. The device falls under the notified category per Notification 29/Misc./03/2020-DC (198) dated 13.9.2021, which explicitly includes software that provides diagnostic or therapeutic functions.

The CDSCO framework classifies medical devices into four risk classes (A, B, C, D) based on intended use and risk to patients. For software devices like the coronary vascular simulation software, classification as Class B indicates a low to moderate risk level, requiring compliance with specific quality and safety standards.

Risk Classification and License Requirements for Class B Software Devices

Class B devices require a manufacturing license under Form MD3 leading to an MD5 license granted by the State Licensing Authority. This process involves product testing, documentation review, and an audit by a notified body listed on the CDSCO Notified Bodies List.

Key takeaways:

• License Type: MD5 Manufacturing License
• Application Form: MD3
• Authority: State Licensing Authority
• Risk Class: B (Low to moderate risk)
• Process Duration: Approximately 3-4 months including test license and audit

Manufacturing License Process (MD5) for Coronary Vascular Simulation Software

The MD5 license process is a multistep journey:

1. Test License (Form MD13): Before applying for MD5, you must secure a test license on Form MD13. This initial step allows product testing and typically takes 1.5 to 2 months.
2. Product Testing: Conduct product testing at CDSCO-approved government labs, which validate the software’s compliance with safety and performance standards. Refer to the list of Testing Laboratories.
3. Documentation Preparation: Prepare comprehensive documents, including Device Master File and Plant Master File, risk management files, and quality management documentation.
4. Application Submission: Apply for the MD5 manufacturing license using Form MD3 through the CDSCO MD Online Portal.
5. Audit by Notified Body: A notified body conducts an on-site audit of your manufacturing setup and quality system to verify compliance.
6. Query Resolution: Address any queries raised by the notified body or CDSCO during the review process.
7. Grant of License: Upon successful audit and document approval, CDSCO grants the MD5 license on Form MD5.

For detailed guidance, our MD5 License Guide covers each step comprehensively.

Manufacturing License Documents Required

For a Class B software device such as this coronary vascular simulation software, the documentation package must be robust and precise. Essential documents include:

• Company Constitution and Legal Entity Proof
• Proof of Ownership or Legal Occupancy of Manufacturing Premises
• Documents of Key Technical Personnel (Qualifications, Experience)
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF): Detailed description of the software design, architecture, development, validation, and maintenance processes. Our Device Master File Guide is an excellent resource.
• Plant Master File (PMF): Description of the manufacturing site and quality systems. See our Plant Master File Guide for best practices.
• Essential Principles Compliance Checklist
• Risk Management File demonstrating compliance with ISO 14971 standards. We recommend following our Risk Management Guide.
• Test Reports from CDSCO-approved labs
• Device Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485:2016 certified

Ensuring completeness and accuracy in these documents significantly reduces review time and audit findings.

Import License Process (MD15) for Software Devices

If your company plans to import the X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device into India, an MD15 import license from the Central Licensing Authority is mandatory.

The process involves:

• Preparing import-specific documents, including existing manufacturing license, Free Sale Certificate, ISO 13485:2016 and CE certificates.
• Submission of application on Form MD14 via the CDSCO MD Online Portal.
• Resolution of any queries raised by CDSCO.
• Grant of MD15 import license.

Note that no test license is required for import. The typical processing duration is 5-6 months.

For a full walkthrough, see our Import License Guide.

Import License Documents Required

Key documents for MD15 license include:

• Valid Manufacturing License (MD5 or MD9)
• Free Sale Certificate from the country of origin
• ISO 13485:2016 Certification
• CE Certificate or equivalent regulatory approval
• Device Master File and Plant Master File
• Wholesale License (if applicable)
• Company Constitution and Legal Documents

Preparing these documents in advance expedites the application process.

Timeline and Processing Duration

For Class B software devices like this one, expect the following approximate timelines:

Total estimated duration: 3 to 4 months for MD5 manufacturing license.

Import licensing (MD15) typically takes 5 to 6 months.

Government Fees and Costs

The fee structure for Class B manufacturing under MD5 is as follows:

• Application Fee: INR 5,000 per application
• Product Fee: INR 500 per product

Additional costs include testing fees charged by government-approved labs and notified body audit fees.

For imports under MD15, fees vary by class and product quantity but are generally higher, reflecting the central authority’s involvement.

Common Challenges and Practical Solutions

Challenge 1: Delays in Test License Approval

Solution: Submit a complete application with all supporting documents and proactively follow up on the CDSCO MD Online Portal to avoid delays.

Challenge 2: Incomplete or Poorly Structured Documentation

Solution: Utilize templates and checklists from our Device Master File and Plant Master File guides to ensure compliance and clarity.

Challenge 3: Audit Non-Conformities

Solution: Conduct internal mock audits before notified body visits. Ensure your QMS, especially document control and risk management, is audit-ready.

Challenge 4: Query Resolution Delays

Solution: Address queries promptly with precise and evidence-backed responses. Engage expert consultants to draft technical replies.

Expert Consultation and Support

Navigating CDSCO licensing, especially for sophisticated software devices, demands technical expertise and regulatory acumen. Our team has successfully supported over 500 manufacturers and importers with:

• End-to-end application preparation
• Device and Plant Master File development
• Risk management implementation
• Liaison with CDSCO and notified bodies

Partnering with seasoned consultants can significantly reduce approval timelines and ensure compliance.

Getting Started with Your CDSCO License Application

To initiate your CDSCO licensing process for the X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device:

1. Register your company on the CDSCO MD Online Portal.
2. Prepare the Device Master File and Plant Master File using expert guidance.
3. Apply for the Test License (Form MD13) and schedule product testing at approved labs.
4. Simultaneously, organize your quality management system documentation and risk management files.
5. Engage a notified body from the official List of Notified Bodies early to plan your audit.
6. Submit your MD5 license application with complete documents upon test license and testing completion.

Starting early and maintaining strict adherence to CDSCO requirements will smooth your path to market entry. Our dedicated regulatory consultants are ready to help you every step of the way.

Begin your licensing journey today with confidence and expert support!