CDSCO License for Burn Resuscitation Decision Support Software
Medical Device Information
Intended Use
The burn resuscitation decision support system (BRDSS) is intended for use in prediction of hourly fluid volume during initial 24 hours of burn resuscitation. It is intended for patients who have greater than 20% total body surface area burn.
Comprehensive Guide to CDSCO Licensing for Burn Resuscitation Decision Support Software (Class C Medical Device)
As specialists with over 25 years of experience in medical device regulatory consulting, we understand the unique challenges manufacturers and importers face when seeking CDSCO licenses in India. The Burn Resuscitation Decision Support Software (BRDSS), a Class C medical device software designed to predict hourly fluid volume for patients with burns exceeding 20% total body surface area, demands a meticulous and compliant approach to navigate India’s regulatory framework.
CDSCO Regulatory Framework for Burn Resuscitation Decision Support Software
The Central Drugs Standard Control Organization (CDSCO) governs medical devices under a risk-based classification system. Software devices like BRDSS fall under this framework and require strict adherence to the notified regulations. According to Notification No. 29/Misc./03/2020-DC (198) dated 13.9.2021, BRDSS is classified as a Class C device due to its critical role in clinical decision-making during burn patient management.
Understanding the regulatory nuances ensures you align product development, quality management, and documentation with statutory requirements, thereby reducing delays and compliance risks.
Risk Classification and License Requirements for Class C Software Devices
Being a Class C device implies moderate to high risk, necessitating a license granted by the Central Licensing Authority. The applicable license is the MD9 Manufacturing License (Form MD7) if manufactured domestically, or the MD15 Import License (Form MD14) if imported.
For BRDSS, which is a software device critical for patient safety, the MD9 license process involves rigorous evaluation including product testing, detailed documentation, and audits by CDSCO inspectors.
Manufacturing License Process (MD9) for Burn Resuscitation Decision Support Software
If you plan to manufacture BRDSS in India, here’s the stepwise approach:
- Test License Application (Form MD13): Initiate by applying for a test license to manufacture the device for testing purposes, taking approximately 1.5 to 2 months.
- Product Testing: Get BRDSS tested at government-approved laboratories to verify compliance with performance and safety standards. Refer to the list of testing laboratories for authorized centers.
- Documentation Preparation: Compile all essential documents including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documentation.
- License Application (Form MD7): Submit the manufacturing license application via the CDSCO MD Online Portal for Class C devices.
- CDSCO Inspection: Undergo an on-site audit by CDSCO inspectors assessing manufacturing premises, quality controls, and compliance.
- Query Resolution: Address any queries raised during inspection or application review promptly.
- License Grant: Upon satisfactory evaluation, the MD9 license is granted, authorizing manufacturing.
The entire manufacturing license process for a Class C device like BRDSS typically spans 4 to 5 months.
Manufacturing License Documents Required for BRDSS
To facilitate a smooth application, ensure the following documents are prepared meticulously:
- Company Constitution and Incorporation Certificates
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Details of Technical Staff Qualifications and Experience
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF): Detailed description of the BRDSS software architecture, algorithms, validation, and intended use. Our detailed Device Master File guide can help you prepare this critical document.
- Plant Master File (PMF): Documentation of manufacturing facilities, infrastructure, equipment, and quality systems. Refer to our Plant Master File guide for comprehensive instructions.
- Essential Principles Checklist confirming conformance to Indian regulatory standards
- Risk Management File demonstrating hazard analysis and mitigation strategies, aligned with international standards. Learn more about risk management here.
- Product Test Reports from CDSCO-approved labs
- Labels and Instructions for Use (IFU) reflecting regulatory compliance
- Quality Management System (QMS) documents, typically ISO 13485:2016 certified
Import License Process (MD15) for Burn Resuscitation Decision Support Software
For importers of BRDSS, the MD15 license is mandatory. This process is managed centrally and involves:
- Document Compilation: Prepare all required documents including the valid manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), and Device & Plant Master Files.
- License Application (Form MD14): Submit the import license application through the CDSCO MD Online Portal.
- Regulatory Review and Queries: The CDSCO reviews submitted documents and may raise queries.
- License Grant: Upon satisfactory compliance, the MD15 license is issued.
The import license process generally takes 5 to 6 months.
Import License Documents Required for BRDSS
- Valid manufacturing license from country of origin
- Free Sale Certificate from the exporting country’s regulatory authority
- ISO 13485:2016 certification
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale license (if applicable in India)
- Company Constitution and Incorporation Certificates
Timeline and Processing Duration
| Process Step | Approximate Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 1 to 1.5 months |
| Document Preparation | 1 month (varies by readiness) |
| License Application Review | 1 to 2 months |
| CDSCO Inspection & Audit | 1 month |
| Query Resolution & Final Grant | 1 month |
Total Time for MD9 Manufacturing License: Approximately 4 to 5 months
Total Time for MD15 Import License: Approximately 5 to 6 months
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD9 (Class C) | Rs. 50,000 | Rs. 1,000 |
| MD15 (Import License) | USD 3,000 (per site) | USD 1,500 (per product) |
Note: Fees are payable via the CDSCO MD Online Portal during application submission.
Common Challenges and Solutions
Challenge 1: Delays in Product Testing
- Solution: Engage early with government-approved labs listed on the CDSCO Testing Laboratories page to book slots and understand test protocols.
Challenge 2: Incomplete Documentation Leading to Queries
- Solution: Use comprehensive checklists and leverage expert guides such as our MD9 License Guide to prepare robust submissions.
Challenge 3: Audit Non-compliance Issues
- Solution: Conduct internal audits and mock inspections to ensure facility and QMS compliance before CDSCO inspection.
Challenge 4: Understanding Software-Specific Regulatory Requirements
- Solution: Address software validation, cybersecurity, and clinical evaluation thoroughly in the Device Master File and Risk Management File.
Expert Consultation and Support
With a track record of assisting over 500 companies in obtaining CDSCO licenses, our team offers tailored consulting services that include:
- Regulatory strategy development for software-based medical devices
- Preparation and review of Device and Plant Master Files
- Guidance through testing and audit processes
- Liaison with CDSCO authorities for query resolution
- Training on Indian regulatory compliance for software medical devices
Getting Started with Your CDSCO License Application for BRDSS
- Assess Your Device Classification: Confirm BRDSS as Class C and decide between manufacturing license (MD9) or import license (MD15).
- Prepare Documentation: Begin compiling essential files including Device Master File, Risk Management File, and QMS certifications.
- Engage Testing Laboratories: Schedule product testing early to avoid bottlenecks.
- Submit Test License (if manufacturing): Apply for MD13 test license via the CDSCO MD Online Portal.
- Plan for Audit: Prepare your facility and quality systems for CDSCO inspections.
- Apply for License: Submit your MD9 or MD15 application, ensuring all fees are paid and documents are complete.
By following these practical steps and leveraging expert support, you can streamline your CDSCO licensing journey and bring your Burn Resuscitation Decision Support Software to the Indian healthcare market confidently and compliantly.
