CDSCO License for Image Acquisition And/Or Optimization Guided By Artificial Intelligence
Medical Device Information
Intended Use
A radiological acquisition and/or optimization guidance system is a device that is intended to aid in the acquisition and/or optimization of images and/or diagnostic signals.
Introduction to Image Acquisition and Optimization Software Guided by AI
In the dynamic landscape of medical technology, Image Acquisition and/or Optimization Guided by Artificial Intelligence represents a cutting-edge software category designed to enhance radiological imaging processes. This device aids clinicians by improving the acquisition and optimization of diagnostic images and signals, thereby elevating diagnostic accuracy and patient outcomes. Given its critical role in healthcare, regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) is essential for market entry and sustained operations in India.
With over 25 years of experience and having assisted more than 500 companies in securing CDSCO licenses, we understand the nuances of navigating India’s regulatory environment for medical devices, especially software in Risk Class B. This comprehensive guide is tailored to manufacturers and importers aiming to obtain the MD5 manufacturing license for such AI-driven imaging software.
CDSCO Regulatory Framework for AI-Guided Image Acquisition Software
The CDSCO regulates medical devices under the Medical Device Rules, 2017 (MDR 2017), which classify devices based on risk and intended use. Software devices like AI-guided image acquisition tools fall under the category of medical devices and must comply with specific regulatory requirements. The relevant notification for your device is 29/Misc./03/2020-DC (198) dated 13.9.2021, which confirms its classification and regulatory pathway.
As a Risk Class B device, it necessitates a state-level manufacturing license (MD5) issued by the State Licensing Authority. The regulatory framework mandates adherence to quality management systems, thorough documentation, product testing, and mandatory audits before license approval.
Risk Classification and License Requirements for Class B Software Devices
According to CDSCO’s classification:
- Class A & B devices require an MD5 license, applied via Form MD3.
- Class B devices pose low to moderate risk, such as AI-based radiological software, meaning stricter controls than Class A but less than Classes C and D.
Manufacturers must first obtain a Test License (Form MD13) to conduct necessary testing in government-approved labs. Following successful testing and audit by a notified body, the final MD5 license is granted.
Manufacturing License Process (MD5) for AI Imaging Software
The MD5 license process is sequential and typically spans 3 to 4 months. Here's a step-by-step breakdown:
Application for Test License (MD13): Submit initial application via the CDSCO MD Online Portal to conduct product testing. The test license is valid for 3 months and takes approximately 1.5 to 2 months to process.
Product Testing: The AI software must be tested in CDSCO-approved laboratories to validate safety, efficacy, and compliance. Refer to the list of testing laboratories for selection.
Document Preparation: Compile comprehensive technical documentation including Device Master File and Plant Master File.
Application for MD5 License (Form MD3): Post-testing, apply for the manufacturing license.
Audit by Notified Body: A notified body conducts an on-site audit of manufacturing premises and quality systems. Check the list of notified bodies for approved auditors.
Query Resolution: Address any observations or queries from the CDSCO or auditors promptly.
License Grant: Upon satisfactory compliance, the MD5 license is issued.
Manufacturing License Documents Required for Class B AI Software
Accurate and complete documentation expedites approval. Key documents include:
- Company Constitution: Certificate of Incorporation or registration documents.
- Proof of Ownership or Lease of Premises: Valid property documents.
- Technical Staff Details: Qualification and experience of key personnel including software engineers and quality managers.
- Fire and Pollution NOCs: Obtain clearance certificates as applicable.
- Device Master File (DMF): Detailed description of the AI software, algorithms, design, and performance data. Our Device Master File guide offers practical insights.
- Plant Master File (PMF): Manufacturing infrastructure, processes, and quality control measures. Learn how to create a compliant PMF here.
- Essential Principles Checklist: Demonstration of compliance with MDR 2017 essential principles.
- Risk Management File: Risk analysis and mitigation strategies per ISO 14971; see our Risk Management guidelines.
- Test Reports: From government-approved labs verifying software safety and performance.
- Labels and Instructions for Use (IFU): Clear, compliant user manuals and labeling.
- Quality Management System (QMS) Documents: ISO 13485:2016 certification and internal SOPs.
Import License Process (MD15) for AI Imaging Devices
If you intend to import this AI software into India, an MD15 import license from the Central Licensing Authority is mandatory. The process, spanning 5 to 6 months, includes:
- Preparation of import-specific documentation.
- Submission of application on the CDSCO MD Online Portal.
- Addressing departmental queries.
- Final grant of import license.
Required documents include manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE certificate, DMF, PMF, wholesale license, and company constitution.
Our detailed Import License guide can help streamline this process.
Timeline and Processing Duration
| Step | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 3 – 4 weeks |
| Document Preparation | 2 – 3 weeks |
| MD5 License Application | 1 week |
| Audit by Notified Body | 2 – 3 weeks |
| Query Resolution and Approval | 2 – 4 weeks |
Total Time: Approximately 3 to 4 months from start to finish.
Government Fees and Costs
- Application fee for MD5 license: ₹5,000 per application.
- Product fee: ₹500 per product.
Additional costs include laboratory testing fees, audit fees charged by notified bodies, and possible consultancy charges if you seek expert assistance.
Common Challenges and Solutions
Challenge: Delays in product testing due to backlog at government labs.
- Solution: Plan test license application well in advance and consider pre-submission lab consultations.
Challenge: Incomplete or inconsistent documentation causing audit observations.
- Solution: Use checklists and expert review to ensure all documents like DMF, PMF, and Risk Management files meet CDSCO standards.
Challenge: Lack of clarity on software validation and cybersecurity requirements.
- Solution: Incorporate comprehensive software validation reports and cybersecurity risk assessments as per international best practices.
Challenge: Communication gaps with the State Licensing Authority leading to prolonged query resolution.
- Solution: Maintain proactive communication and timely responses to queries.
Expert Consultation and Support
Navigating the CDSCO regulatory framework for AI-based medical software can be complex. With our extensive experience supporting over 500 medical device firms, we provide tailored consultation services including:
- Gap analysis of your current documentation.
- Assistance in preparing DMF, PMF, and Risk Management files.
- Coordination with notified bodies and testing labs.
- Application submission and follow-up.
- Training on post-market regulatory compliance.
Engaging expert support significantly reduces approval timelines and mitigates risks of non-compliance.
Getting Started with Your CDSCO License Application
Assess Device Classification: Confirm your device is Risk Class B as per Medical Device Classification.
Initiate Test License Application: Prepare and submit Form MD13 via the CDSCO MD Online Portal.
Identify Testing Laboratory: Select an approved lab from the CDSCO’s Testing Laboratories list.
Compile Documentation: Develop Device Master File, Plant Master File, risk management, and QMS documentation with expert guidance.
Schedule Notified Body Audit: Coordinate with notified bodies early to align audit schedules.
Maintain Open Communication: Regularly track application status on the CDSCO portal and promptly address any queries.
By following these actionable steps and leveraging expert assistance, manufacturers and importers can successfully navigate the CDSCO regulatory process for AI-guided image acquisition software, ensuring timely market access and compliance.
For further detailed guidance, explore our MD5 License Guide.
We are here to support your regulatory journey with proven strategies and comprehensive documentation support to help you achieve CDSCO approval efficiently and confidently.
