CDSCO License for Lung Computed Tomography System, Computer- Aided Detection
Medical Device Information
Intended Use
To assist radiologists in the review of multi-slice computed tomography (msct) exams of the chest and highlight potential nodules that the radiologist should review.
Comprehensive CDSCO Licensing Guide for Lung Computed Tomography System, Computer-Aided Detection (Class B Software)
As regulatory consultants with over 25 years of experience and a track record of assisting 500+ medical device companies, we understand the critical importance of securing timely and compliant CDSCO licenses for innovative devices like the Lung Computed Tomography System, Computer-Aided Detection (CAD). This Class B software device is designed to assist radiologists in reviewing multi-slice computed tomography (MSCT) chest exams by highlighting potential nodules, thus enhancing diagnostic accuracy.
Navigating the Indian regulatory landscape for such advanced medical software requires detailed knowledge of the CDSCO framework, meticulous documentation, and strategic planning. In this guide, we provide a step-by-step roadmap, practical timelines, cost breakdowns, and solutions to common challenges to help you successfully enter the Indian market.
CDSCO Regulatory Framework for Lung CT System CAD Software
The Central Drugs Standard Control Organization (CDSCO) governs the approval process for medical devices in India. Given the device’s classification as Class B and its software nature, it falls under the purview of the State Licensing Authority for manufacturing licenses (MD5 license) and the Central Licensing Authority for import licenses.
Your Lung CT CAD software must comply with the Medical Device Rules (MDR) 2017, and subsequent amendments including notification 29/Misc./03/2020-DC (198), dated 13th September 2021, which specifically references this device category.
Risk Classification and License Requirements
- Device Risk Class: B (Low to moderate risk)
- Applicable License: MD5 Manufacturing License (Form MD3)
- Licensing Authority: State Licensing Authority
- Approval Timeline: Approximately 3-4 months (including test license, testing, audit, and final approval)
The MD5 license is mandatory for manufacturers intending to produce Class A and B devices in India. For the Lung CT CAD software, this means the device must undergo a rigorous quality and safety assessment before market entry.
Manufacturing License Process (MD5 License)
The MD5 license process involves several sequential steps:
- Test License Application (Form MD13): Required before manufacturing begins. This license takes about 1.5 to 2 months to obtain and allows limited production for testing purposes.
- Product Testing: The Lung CT CAD software must be tested at a CDSCO-approved government laboratory to validate performance and safety. Refer to the list of testing laboratories for accredited centers.
- Documentation Preparation: Assemble all required documents, including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and QMS documents.
- License Application (Form MD3): Submit the MD5 application through the CDSCO MD Online Portal after successful testing.
- Audit by Notified Body: An audit of your manufacturing facility and quality systems is conducted by a CDSCO-approved notified body. Check the notified bodies list to select the appropriate auditor.
- Resolution of Queries: Address any observations or deficiencies raised by the regulatory authorities or auditors promptly.
- Grant of License (Form MD5): Upon satisfactory review, the MD5 manufacturing license is granted.
Manufacturing License Documents Required
Detailed and accurate documentation is critical. For the Lung CT CAD software, ensure submission of:
- Company Constitution (Incorporation Certificate, Memorandum and Articles of Association)
- Proof of Ownership or Lease of Manufacturing Premises
- Qualification and Experience Certificates of Technical Staff
- Fire Safety NOC
- Pollution Control Board NOC (if applicable)
- Device Master File (DMF): Comprehensive technical documentation on device design, software architecture, validation, and intended use (see our Device Master File guide)
- Plant Master File (PMF): Details of manufacturing processes, quality control, and infrastructure (refer to our Plant Master File guide)
- Essential Principles Checklist
- Risk Management File (per ISO 14971 standards, see our Risk Management guide)
- Test Reports from Government-Approved Labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents, preferably ISO 13485:2016 certified
Import License Process (MD15 License)
If you intend to import the Lung CT CAD software into India, the MD15 import license is required from the Central Licensing Authority. The process is as follows:
- Document Preparation: Assemble required documents including manufacturing license from the country of origin, Free Sale Certificate, CE Certificate, ISO 13485:2016 certification, Device and Plant Master Files, Wholesale License, and company constitution.
- Application Submission: File Form MD14 through the CDSCO MD Online Portal.
- Queries Resolution: Respond to any departmental queries.
- License Grant: MD15 license granted typically within 5-6 months.
Note: For this device category, no test license is required prior to import application.
Import License Documents Required
- Valid Manufacturing License from Country of Origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Marking Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale License for distribution in India
- Company Constitution Documents
Timeline and Processing Duration
| Process Step | Expected Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 3 – 4 weeks |
| Documentation Preparation | 2 – 4 weeks (parallel) |
| License Application (MD5) | Immediate after testing |
| Audit by Notified Body | 3 – 4 weeks |
| Query Resolution | 2 – 3 weeks |
| Final License Grant | Within 3-4 months total |
In total, expect approximately 3-4 months from start to finish for manufacturing license approval.
Government Fees and Costs
For the MD5 license specific to Class B devices like the Lung CT CAD software:
- Application Fee: INR 5,000 per application
- Product Fee: INR 500 per product
Additional costs include:
- Testing fees at government-approved laboratories (varies by lab and test scope)
- Notified body audit fees (typically INR 50,000 to INR 1,00,000 depending on scope)
- Consultancy and documentation preparation (varies by service provider)
Budgeting carefully for these expenses upfront can prevent delays and budget overruns.
Common Challenges and Solutions
Challenge 1: Delays in product testing due to lab backlogs.
- Solution: Schedule testing appointments early and consider alternate CDSCO-approved labs if available.
Challenge 2: Incomplete or inconsistent documentation causing audit observations.
- Solution: Utilize expert consultants to prepare and review DMF and PMF thoroughly before submission.
Challenge 3: Misinterpretation of intended use leading to classification errors.
- Solution: Refer to the official medical device classification guidelines and consult CDSCO experts.
Challenge 4: Query resolution delays prolonging license grant.
- Solution: Respond promptly with clear, evidence-backed answers to regulatory queries.
Expert Consultation and Support
Given the complexity of regulatory requirements for medical device software, engaging experienced regulatory consultants can streamline the process significantly. Our team has successfully guided over 500 companies, ensuring document accuracy, audit readiness, and timely license approvals. We offer tailored support including:
- Preparation of Device and Plant Master Files
- Risk management strategy implementation
- Liaison with notified bodies and CDSCO officials
- End-to-end license application management
Getting Started with Your CDSCO License Application
To initiate your Lung Computed Tomography System CAD software licensing:
- Assess your device classification and confirm it as Class B.
- Prepare or update your Device Master File and Plant Master File with detailed technical and manufacturing information.
- Apply for the Test License (MD13) through the CDSCO MD Online Portal.
- Schedule product testing at a CDSCO-approved testing laboratory.
- Compile all documentation including QMS certificates, risk management files, and regulatory checklists.
- Engage a notified body early to schedule the audit.
- Submit your MD5 license application (Form MD3) post successful testing and audit readiness.
Starting early and maintaining transparent communication with regulatory authorities will greatly enhance your chances of smooth and timely approval. For detailed, tailored assistance, consider partnering with seasoned regulatory consultants who specialize in CDSCO medical device licensing.
By following this comprehensive roadmap, your Lung CT CAD software can successfully navigate the regulatory landscape and reach Indian healthcare providers, contributing significantly to improved patient outcomes.
