CDSCO License for Angiographic Coronary Vascular Physiologic Simulation Software

Introduction to Angiographic Coronary Vascular Physiologic Simulation Software and Regulatory Importance

Angiographic Coronary Vascular Physiologic Simulation Software serves a critical role in cardiovascular healthcare by assisting clinicians in identifying functionally significant coronary artery disease. As an advanced medical device software categorized under Class C by CDSCO, it carries moderate to high risk, demanding rigorous regulatory compliance to ensure safety and efficacy. In India’s evolving medical device landscape, obtaining the proper CDSCO license is not just a regulatory formality but a gateway to market access, patient safety, and commercial success.

With over 25 years of expertise and having supported 500+ companies, we provide clear, actionable guidance to help you secure your CDSCO license efficiently.

CDSCO Regulatory Framework for Software Medical Devices (Class C)

The Central Drugs Standard Control Organization (CDSCO) governs medical devices under the Medical Device Rules (MDR) 2017, with amendments incorporating software as a medical device (SaMD). Since your device is a Class C software device, it falls under the Central Licensing Authority's jurisdiction, requiring a stringent approval process including testing, audit, and compliance verification.

The relevant notification for your device is 29/Misc./03/2020-DC (198), dated 13.09.2021, which formally classifies angiographic physiologic simulation software as a Class C device.

Risk Classification and License Requirements

Class C devices represent moderate to high risk and include many diagnostic and therapeutic software tools. For your angiographic coronary vascular physiologic simulation software, the mandatory license is the MD9 Manufacturing License (Application Form MD7) for manufacturers, and the MD15 Import License for importers.

• MD9 License: Required for local manufacturing of Class C devices.
• MD15 License: Required for importing Class C devices into India.

For both licenses, rigorous compliance with technical, quality, and safety standards is essential.

Manufacturing License Process (MD9) for Class C Software Devices

The MD9 license process is governed by the CDSCO Central Licensing Authority and typically spans 4 to 5 months. The steps include:

1. Test License Application (Form MD13): Initiate with a test license application to legally conduct product testing. This stage takes approximately 1.5 to 2 months.
2. Product Testing: Conduct testing at government-approved laboratories to validate device safety and performance. Reference the list of approved testing laboratories.
3. Document Preparation: Compile the required documents including Device Master File (DMF), Plant Master File (PMF), risk management files, etc.
4. MD9 License Application (Form MD7): Submit the manufacturing license application via the CDSCO MD Online Portal.
5. Audit by CDSCO Inspectors: Undergo on-site audit verifying compliance with QMS and manufacturing standards.
6. Query Resolution: Respond promptly to any queries from CDSCO or auditors.
7. Grant of License (Form MD9): Upon satisfying all criteria, the license is granted.

Refer to our detailed MD9 License Guide for step-by-step assistance.

Manufacturing License Documents Required for Angiographic Software

Prepare the following comprehensive documentation to strengthen your application:

• Company Constitution Documents: Certificate of Incorporation, Memorandum & Articles of Association.
• Proof of Ownership or Lease of Manufacturing Premises: Registered address proof.
• Technical Staff Details: Qualification and experience certificates of software developers, quality assurance, and regulatory personnel.
• Fire and Pollution No Objection Certificates (NOC): As mandated by local authorities.
• Device Master File (DMF): Detailed description of your software architecture, algorithms, validation studies. Our Device Master File Guide helps streamline this.
• Plant Master File (PMF): Manufacturing processes, infrastructure, and quality control measures. See our Plant Master File Guide.
• Essential Principles Checklist: Compliance with safety and performance requirements.
• Risk Management File: Comprehensive risk analysis and mitigation aligned with ISO 14971. Learn more about implementing medical device risk management.
• Test Reports: From CDSCO-approved labs validating device performance.
• Device Labels and Instructions for Use (IFU): Clear, compliant labeling and user manuals.
• Quality Management System (QMS) Documents: ISO 13485 certification and internal SOPs.

Import License Process (MD15) for Class C Software Devices

If you are importing the angiographic software, the MD15 import license is mandatory. The process is managed by the Central Licensing Authority and typically takes 5 to 6 months. Key steps include:

1. Gather Required Documents: Including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE certificates, and other technical documents.
2. License Application (Form MD14): Apply via the CDSCO MD Online Portal.
3. Departmental Review and Queries: Address any clarifications raised.
4. License Grant (Form MD15): Upon approval, receive the import license.

The Import License Guide offers detailed insights.

Import License Documents Required

• Valid manufacturing license from the country of origin.
• Free Sale Certificate.
• ISO 13485:2016 certification.
• CE Certificate or equivalent international certification.
• Device Master File and Plant Master File.
• Wholesale license for distribution in India.
• Company constitution documents.

Timeline and Processing Duration

Government Fees and Costs

• MD9 License: Rs 50,000 per application + Rs 1,000 per product.
• MD15 Import License: Class C/D fees approximately Rs 3,00,000 per site + Rs 1,50,000 per product (converted to INR as per current exchange rates).

Additional costs to anticipate include testing fees at approved labs and consultancy fees if you engage regulatory experts.

Common Challenges and Solutions

• Delays in Testing: Select accredited laboratories early and schedule your tests promptly to avoid bottlenecks.
• Incomplete Documentation: Utilize our comprehensive Device Master File Guide and checklist templates to ensure completeness.
• Audit Non-compliance: Prepare rigorously for audits, focusing on QMS documentation and technical staff readiness.
• Query Management: Respond quickly and thoroughly to CDSCO queries to prevent delays.

Expert Consultation and Support

Navigating the CDSCO regulatory landscape for Class C medical device software is complex. Our experience with over 500 successful license applications enables us to provide tailored strategies, document preparation, liaison with authorities, and audit readiness support. We recommend engaging expert consultants early to streamline your path to market.

Getting Started with Your CDSCO License Application

1. Register on the CDSCO MD Online Portal: Create your user account for application submissions.
2. Initiate Test License (MD13) Application: This is mandatory prior to full license application for manufacturing.
3. Engage Accredited Testing Labs: Book your product testing early to avoid delays.
4. Begin Document Preparation: Use our guides to compile DMF, PMF, risk management files, and QMS documentation.
5. Plan for Audit: Organize internal pre-audit checks with your quality team and consultants.
6. Submit Manufacturing License Application (Form MD7) or Import License (Form MD14): Once testing and documentation are complete.

Following these practical steps will position your angiographic coronary vascular physiologic simulation software for successful regulatory approval and market entry in India.

For personalized assistance, detailed checklists, and audit support, contact our regulatory experts who have empowered hundreds of companies to navigate CDSCO licensing with confidence.