CDSCO License for Radiological computer- assisted diagnostic software for lesions suspicious of cancer
Medical Device Information
Intended Use
A radiological computer-assisted diagnostic software for lesions suspicious of cancer is an image processing prescription device intended to aid in the characterization of lesions as suspicious for cancer identified on acquired medical images such as magnetic resonance, mammography, radiography, or computed tomography. The device characterizes lesions based on features or information extracted from the images and provides information about the lesion(s) to the user.
Comprehensive Guide to CDSCO Licensing for Radiological Computer-Assisted Diagnostic Software (Class C)
Navigating the regulatory landscape for medical devices in India can be complex, especially for sophisticated technologies like radiological computer-assisted diagnostic (CAD) software designed to aid in cancer lesion characterization. As seasoned regulatory consultants with over 25 years of experience and having supported 500+ companies in securing CDSCO licenses, we provide you with an authoritative, step-by-step roadmap to obtain your MD9 manufacturing license efficiently.
Understanding the Device and Regulatory Importance
Your device, a radiological computer-assisted diagnostic software for lesions suspicious of cancer, falls under the Interventional Radiology category and is classified as a Class C medical device. This reflects a moderate to high risk profile due to its critical role in cancer diagnosis. The device processes medical images from MRI, mammography, radiography, or CT scans to aid clinicians in lesion characterization, making regulatory compliance vital for patient safety and market access.
India’s Central Drugs Standard Control Organization (CDSCO) mandates stringent licensing for Class C devices to ensure efficacy, safety, and quality. Timely and accurate adherence to these regulatory requirements is essential to avoid delays, penalties, or market entry barriers.
CDSCO Regulatory Framework for Class C Radiological CAD Software
Radiological CAD software is regulated under the Medical Device Rules (MDR) 2017, enforced by CDSCO. As a Class C device, it requires a central license (MD9) issued by the CDSCO Central Licensing Authority. The license process entails rigorous testing, documentation, and an onsite audit to confirm compliance with Indian standards and international best practices.
For more on medical device classification, refer to our detailed Medical Device Classification guide.
Risk Classification and License Requirements
- Risk Class: C (Moderate to high risk)
- License Type: MD9 (Manufacturing License)
- Issuing Authority: CDSCO Central Licensing Authority
- Application Form: MD7
- Audit: Conducted by CDSCO Inspectors
MD9 Manufacturing License Process for Class C Devices
The entire approval process typically spans 4 to 5 months and involves the following key steps:
Test License Application (Form MD13): Obtain a test license to manufacture and test the device prototype. This stage takes approximately 1.5 to 2 months.
Product Testing: Conduct mandatory product testing at CDSCO approved government laboratories. Testing ensures compliance with essential principles and performance standards.
Document Preparation: Compile comprehensive documentation including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) evidence.
License Application (Form MD7): Submit your manufacturing license application through the CDSCO MD Online Portal.
CDSCO Audit: The CDSCO team audits your manufacturing facility and reviews documents.
Query Resolution: Address any queries or clarifications raised by CDSCO inspectors promptly.
License Grant: Upon successful audit and document approval, the MD9 license is granted on Form MD9.
Essential Documents Required for MD9 License Application
To ensure a smooth approval process, prepare the following documentation meticulously:
- Company Constitution and Incorporation Certificate: Proof of legal entity.
- Proof of Premises Ownership or Lease Agreement: Valid premises documentation.
- Technical Staff Details: Qualifications and experience of key personnel involved in manufacturing.
- Fire and Pollution NOCs: No Objection Certificates from local authorities.
- Device Master File (DMF): Detailed technical specifications, design, and manufacturing process of the software. Our Device Master File guide offers comprehensive insights.
- Plant Master File (PMF): Documentation of manufacturing facility and quality controls. Learn how to prepare a PMF here: Plant Master File Guide.
- Essential Principles Checklist: Compliance checklist based on Indian MDR.
- Risk Management File: Risk analysis and mitigation strategies following ISO 14971 standards. For guidance, visit our Risk Management resource.
- Test Reports: Results from government-approved testing laboratories. Refer to available Testing Laboratories.
- Product Labels and Instructions for Use (IFU): Compliant with CDSCO labeling requirements.
- Quality Management System (QMS) Documentation: ISO 13485:2016 certification and internal SOPs.
Import License Process (MD15) for Radiological CAD Software
If you plan to import this software into India, an MD15 import license granted by CDSCO Central Licensing Authority is mandatory. Unlike manufacturing, no test license is required, but document preparation and application on the CDSCO portal remain essential.
Required documents include:
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 and CE Certificate
- Device and Plant Master Files
- Wholesale license
- Company Constitution
Government fees vary by device risk class and number of products imported; more details can be found in our Import License Guide.
Timeline and Processing Duration
| Process Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 2 – 4 weeks |
| Document Preparation | 3 – 4 weeks |
| License Application & Audit | 1.5 – 2 months |
| Total Estimated Time | 4 – 5 months |
Government Fees and Costs
- Test License (MD13): Government fees typically around INR 5,000
- MD9 Manufacturing License Application: INR 50,000 per application
- Product Fee: INR 1,000 per product
Additional costs include audit fees charged by notified bodies and testing laboratory fees. For notified bodies, consult the Notified Bodies List.
Common Challenges and Practical Solutions
Challenge 1: Delayed Test Report Availability
- Solution: Engage accredited labs early and schedule tests in advance.
Challenge 2: Incomplete Documentation
- Solution: Use comprehensive checklists and expert consultation to ensure all files (DMF, PMF, risk files) are complete.
Challenge 3: Audit Non-Compliance
- Solution: Conduct pre-audit internal assessments and corrective actions.
Challenge 4: Query Resolution Delays
- Solution: Assign dedicated regulatory personnel for prompt communication with CDSCO.
Expert Consultation and Support
Given the technical complexity and regulatory nuances of Class C radiological CAD software, partnering with an experienced regulatory consultant can dramatically reduce approval timelines and minimize risks. We offer tailored support, including document preparation, audit readiness, and direct liaison with CDSCO officials.
Getting Started with Your CDSCO License Application
- Assess Device Classification: Confirm your device classification as Class C.
- Prepare for Test License: Initiate your MD13 application on the CDSCO MD Online Portal.
- Identify Testing Laboratories: Engage government-approved labs early.
- Compile Documentation: Develop your Device Master File, Plant Master File, Risk Management File, and QMS documents.
- Plan for Audit: Schedule and prepare your facility for CDSCO inspection.
- Submit MD9 Application: Apply using Form MD7 and monitor the application status.
- Address Queries Quickly: Maintain open communication to resolve any CDSCO concerns.
Embarking on this regulatory journey with expert guidance ensures your radiological CAD software meets Indian regulatory standards, enabling timely market entry and commercial success. For personalized assistance or to begin your licensing process, connect with our regulatory experts today.
