CDSCO License for Software for public thoracic and abdominal health screening diagnostic X- ray system
Medical Device Information
Intended Use
A software, which is designed to process data obtained from a thoracic and abdominal public health screening diagnostic X-ray system. The resultant data are provided for diagnosis, etc. This term may involve the recording media where the software are stored.
Comprehensive Guide to CDSCO Licensing for Software in Thoracic and Abdominal Health Screening Diagnostic X-Ray Systems
As pioneers with over 25 years of experience in medical device regulatory affairs, we understand the critical importance of navigating the Central Drugs Standard Control Organization (CDSCO) licensing process efficiently. For manufacturers and importers of software designed for public thoracic and abdominal health screening diagnostic X-ray systems—classified as Class B devices—compliance with CDSCO requirements is paramount to entering and succeeding in the Indian medical device market.
Understanding Your Device: Software for Public Thoracic and Abdominal Health Screening Diagnostic X-Ray Systems
This software processes data obtained from thoracic and abdominal X-ray systems used in public health screening, facilitating diagnostic interpretation. It may also include the recording media where the software is stored. As a Class B medical device under the CDSCO framework, this software carries a moderate risk level requiring state-level licensing under the MD5 license category.
CDSCO Regulatory Framework for Software Medical Devices
Software intended for diagnostic use is regulated stringently due to its direct impact on patient outcomes. Under CDSCO’s regulatory framework, software that processes diagnostic data falls under the Medical Device Rules (MDR), 2017, and must comply accordingly. The latest notification (29/Misc./03/2020-DC (198), dated 13.9.2021) specifically addresses software in diagnostic X-ray systems, ensuring clarity on classification and submission requirements.
Risk Classification and License Requirements for Your Software
Per CDSCO classification guidelines, diagnostic software processing thoracic and abdominal X-ray data is categorized as Class B – low to moderate risk. This classification mandates obtaining an MD5 manufacturing license from the State Licensing Authority for domestic manufacturers. For importers, separate import licensing applies (MD15), but this guide focuses on the manufacturing license process.
Step-by-Step Manufacturing License Process (MD5) for Class B Software Devices
Apply for Test License (Form MD13): Before the manufacturing license, manufacturers must secure a test license, typically taking 1.5 to 2 months. This permits limited-scale production to facilitate product testing.
Product Testing: Conduct testing at government-approved laboratories to validate device safety and performance. Refer to the CDSCO list of testing laboratories for accredited facilities.
Document Preparation: Compile the required technical and quality documents, including Device Master File and Plant Master File.
Submit Manufacturing License Application (Form MD3): File your complete application through the CDSCO MD Online Portal.
Audit by Notified Body: Engage an authorized notified body to conduct a facility and quality system audit. The list of notified bodies includes entities qualified for MD5 audits.
Resolve Queries: Promptly address any clarifications or deficiencies raised by the CDSCO or notified body.
License Grant (Form MD5): Upon successful audit and document approval, the State Authority issues the MD5 manufacturing license.
The entire process averages around 3 to 4 months.
Essential Documents Required for MD5 License Application
- Company Constitution: Legal incorporation documents.
- Proof of Ownership or Lease of Premises: Demonstrates manufacturing site legitimacy.
- Technical Staff Qualification and Experience: Details of competent personnel.
- Fire and Pollution NOCs: Ensures compliance with safety and environmental norms.
- Device Master File (DMF): Comprehensive technical file as per our detailed Device Master File guide.
- Plant Master File (PMF): Documentation of manufacturing processes; refer to our Plant Master File guide.
- Essential Principles Checklist: Compliance with applicable standards.
- Risk Management File: Demonstrates hazard identification and mitigation strategies, crucial for software devices; learn more about implementing risk management.
- Test Reports: From government-approved labs validating device performance.
- Labels and Instructions for Use (IFU): Clear product labeling and user guidance.
- Quality Management System (QMS) Documents: Evidence of robust manufacturing controls.
Import License Process (MD15) Overview
While this guide primarily addresses manufacturing licensing, importers of Class B software devices must secure the MD15 license from the Central Licensing Authority. This involves submitting detailed documentation, including manufacturing licenses from the country of origin, ISO 13485 certification, CE certificates, and more. The process typically spans 5-6 months due to central authority review. For detailed guidance, visit our Import License Guide.
Timeline and Processing Duration
| Step | Duration |
|---|---|
| Test License (MD13) | 1.5-2 months |
| Product Testing | 1-1.5 months |
| Document Preparation | 2-3 weeks |
| Application Submission & Audit | 1-1.5 months |
| Query Resolution & License Grant | 2-3 weeks |
Total Expected Duration: Approximately 3 to 4 months.
Government Fees and Associated Costs
- Application Fee: Rs. 5,000 per application.
- Product Fee: Rs. 500 per product.
Additional expenses may include:
- Testing laboratory fees.
- Notified body audit charges (varies by body).
- Consultancy or professional service fees, if engaged.
Budgeting accurately ensures smooth financial planning for your CDSCO licensing journey.
Common Challenges and Practical Solutions
Incomplete Documentation: Missing or inconsistent files frequently delay approval. We recommend pre-audit internal reviews and checklists to ensure completeness.
Delays in Testing: Selecting government-approved labs early and scheduling tests promptly can streamline timelines.
Audit Non-Compliance: Familiarize your team with audit expectations and maintain up-to-date QMS documentation.
Query Resolution Delays: Assign dedicated personnel to monitor and respond to CDSCO communications swiftly.
Our extensive experience with over 500 successful license approvals enables us to anticipate and mitigate these common issues.
Expert Consultation and Support
Navigating CDSCO licensing for Class B software devices demands specialized knowledge. We offer tailored consulting, document preparation, gap analysis, and liaison services to expedite your license acquisition with confidence.
Getting Started with Your CDSCO License Application
Assess your Device Documentation: Gather all technical files, QMS evidence, and compliance documents.
Apply for Test License (MD13): Submit through the CDSCO MD Online Portal.
Plan Product Testing: Coordinate with government-approved labs early.
Prepare for Audit: Engage a notified body from the official list and ready your facilities.
Submit Manufacturing License Application (MD3): Once testing is successful and audit readiness confirmed.
Starting early and maintaining proactive communication with CDSCO will considerably enhance your licensing experience and time to market.
For more detailed insights and personalized assistance, explore our comprehensive MD5 License Guide or contact our expert team today.
