CDSCO License for Quantitative calculation software for IGC test
Medical Device Information
Intended Use
A software that performs quantitative calculation of blood flow in relation to a brightness time change based on information obtained from video images of indocyanine green angiography.
Introduction to Quantitative Calculation Software for IGC Test and Its Regulatory Importance
As a specialized software designed to perform quantitative calculations of blood flow via brightness time changes from indocyanine green angiography (IGC), this medical device plays a critical role in diagnostics. Given its classification as a Class B medical device under CDSCO regulations and its specific notification (29/Misc./03/2020-DC (198) dated 13.9.2021), regulatory compliance is essential to legally market and distribute this software within India. Proper licensing not only ensures adherence to safety and performance standards but also builds trust with healthcare providers and end users.
With over 25 years of experience and having assisted 500+ companies in obtaining CDSCO licenses, we understand the intricacies involved in navigating the Indian regulatory landscape. This guide provides a comprehensive roadmap tailored for manufacturers and importers of this software, focusing on the Class B risk profile.
CDSCO Regulatory Framework for Software Medical Devices
Software as a Medical Device (SaMD) is now an established category under CDSCO's regulatory purview. The CDSCO classifies medical devices based on risk, and software that influences clinical decisions or patient management is typically categorized as Class B or higher. For your quantitative calculation software for the IGC test, which processes video images to calculate blood flow, Class B classification applies.
Regulatory oversight ensures that such software meets quality, safety, and efficacy standards before entering the market. The CDSCO framework requires manufacturers to obtain the appropriate license, conduct testing in government-approved labs, and maintain thorough documentation.
Risk Classification and License Requirements for Class B Software
Class B devices are considered low to moderate risk and require a Manufacturing License (MD5) issued by the State Licensing Authority. This involves a multi-step process, including obtaining a Test License, product testing, document submission, and an audit by a notified body.
Key points for Class B devices:
- License Type: MD5 (Form MD3 application)
- Licensing Authority: State CDSCO
- Total Processing Time: Approximately 3-4 months (including test license and audit)
- Fees: Rs 5,000 per application + Rs 500 per product
You can verify the device classification and requirements further on our Medical Device Classification page.
Manufacturing License Process (MD5) for Class B Software
The MD5 license process for your software involves several crucial steps:
Test License Application (Form MD13): Apply for a test license granting permission to manufacture and test the device. This step typically takes 1.5 to 2 months.
Product Testing: Conduct mandatory testing at government-approved laboratories to verify safety and performance. Refer to the Testing Laboratories list for accredited facilities.
Document Preparation: Compile comprehensive documentation including technical details, quality management system, and compliance evidence.
License Application (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal.
Audit by Notified Body: Undergo an audit conducted by a CDSCO notified body. You can consult the Notified Bodies list to select an authorized auditor.
Query Resolution: Address any queries raised by the licensing authority or the notified body promptly.
License Grant (Form MD5): Upon successful completion of all stages, the manufacturing license is granted.
For detailed guidance, our MD5 License Guide provides step-by-step insights.
Manufacturing License Documents Required for Class B Software
Preparing a robust dossier is critical to avoid delays. For your quantitative calculation software, the following documents are essential:
- Company Constitution and Incorporation Proof: Legal documents establishing your business.
- Proof of Premises Ownership or Lease Agreement: Validating the manufacturing site.
- Technical Staff Details: Qualifications and experience of personnel involved in manufacturing and quality assurance.
- Fire and Pollution NOCs: No-objection certificates from relevant authorities.
- Device Master File (DMF): Detailed product specifications, design, and validation data. Our Device Master File guide can assist in preparation.
- Plant Master File (PMF): Information about the manufacturing facility and quality systems. Refer to our Plant Master File guide.
- Essential Principles Checklist: Compliance with applicable safety and performance requirements.
- Risk Management File: Documentation of risk analysis and mitigation strategies, crucial for software devices. Implement best practices with our Risk Management guide.
- Test Reports: Laboratory test results validating device performance.
- Labels and Instructions for Use (IFU): Clear, compliant labeling and user manuals.
- Quality Management System (QMS) Documents: Evidence of ISO 13485:2016 certification and internal procedures.
Ensuring completeness and accuracy of these documents significantly expedites the approval process.
Import License Process (MD15) for Software Medical Devices
If you are importing the quantitative calculation software into India, an Import License (MD15) is mandatory and issued by the Central Licensing Authority. The process is as follows:
Document Preparation: Compile necessary documents including manufacturing license, Free Sale Certificate, ISO 13485:2016 certification, CE certificate, Device and Plant Master Files, wholesale license, and company constitution.
Submission of Application (Form MD14): Apply through the CDSCO MD Online Portal.
Queries Resolution: Respond to any queries raised by CDSCO officials.
License Grant (Form MD15): The import license is issued upon successful review.
The entire process usually spans 5-6 months. Detailed procedural information is available in our Import License Guide.
Import License Documents Required for Class B Software
Key documents include:
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale License
- Company Constitution
Accurate and complete documentation minimizes processing delays.
Timeline and Processing Duration
For your Class B software device, expect the following timelines:
| Activity | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing (Govt Labs) | 3 – 4 weeks |
| Document Preparation | 2 – 3 weeks |
| License Application & Audit | 4 – 6 weeks |
| Query Resolution & Final Grant | 2 – 4 weeks |
Total: Approximately 3-4 months for manufacturing license (MD5).
Import licenses (MD15) generally take 5-6 months.
Government Fees and Costs for Class B Software Licensing
- MD5 Manufacturing License: Rs 5,000 per application + Rs 500 per product
- Test License (MD13): Included in the process; separate fees may apply depending on state
These fees are payable online via the CDSCO portal.
Additional costs may include:
- Testing laboratory charges
- Notified Body audit fees
- Consultancy fees if external expert support is engaged
Budgeting for these fees upfront avoids surprises during the licensing journey.
Common Challenges and Solutions in CDSCO Licensing for Software Devices
- Incomplete Documentation: Ensure all required documents, especially DMF and risk management files, are thorough and up-to-date.
- Delays in Testing: Schedule testing promptly with government-approved labs to avoid bottlenecks.
- Audit Nonconformities: Prepare for audits by conducting internal pre-audits and training staff.
- Regulatory Updates: Stay informed about notifications like 29/Misc./03/2020-DC (198) to remain compliant.
Our experience shows proactive preparation and expert consultation significantly reduce approval times.
Expert Consultation and Support
Navigating CDSCO licensing for Class B software devices can be complex. With our 25+ years of expertise and proven track record across 500+ companies, we provide tailored support including:
- Gap analysis of your documentation
- Strategic planning of test and audit scheduling
- Direct liaison with state licensing authorities and notified bodies
- Training your team on regulatory compliance
Partnering with experienced consultants mitigates risks and accelerates market entry.
Getting Started with Your CDSCO License Application for Quantitative Calculation Software
- Assess Device Classification: Confirm your software’s Class B status using CDSCO guidance.
- Prepare a Project Timeline: Allocate 3-4 months for the entire MD5 license process.
- Collect Required Documents: Begin compiling all necessary files, focusing on DMF, PMF, and risk management.
- Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal to start testing.
- Schedule Product Testing: Contact listed government-approved labs early to book testing slots.
- Engage a Notified Body: Identify and appoint a notified body from the Notified Bodies list for your audit.
- Submit Manufacturing License Application: Apply using Form MD3 once testing and documentation are ready.
- Prepare for Audit and Queries: Conduct internal reviews and be prompt in responding to CDSCO queries.
Starting with a clear action plan and expert guidance ensures a smooth licensing journey for your quantitative calculation software for the IGC test. Contact us to leverage our expertise and secure your CDSCO license efficiently.
