CDSCO License for Supporting software for differential diagnosis with endoscopic imaging

Introduction to Supporting Software for Differential Diagnosis with Endoscopic Imaging and Its Regulatory Importance

Supporting software for differential diagnosis with endoscopic imaging is a critical medical device designed to enhance diagnostic accuracy by processing endoscopic images and providing quantitative analysis. This software outputs numeric data, graphs, and diagnostic suggestions including benign/malignant differentiation and disease staging. Given its significant role in clinical decision-making, regulatory oversight is essential to ensure safety, efficacy, and compliance with Indian medical device regulations.

As a company with over 25 years of experience and having assisted more than 500 manufacturers and importers, we understand the complexities involved in navigating the Central Drugs Standard Control Organization (CDSCO) licensing process for such advanced software devices. This guide specifically addresses the regulatory framework, risk classification, and step-by-step licensing process for Class C medical device software in India.

CDSCO Regulatory Framework for Supporting Software as a Medical Device

The CDSCO classifies medical devices including software based on risk to public health. Our software, notified under Notification 29/Misc./03/2020-DC (198) dated 13.9.2021, falls under Class C due to its diagnostic function, which directly influences clinical decisions.

Under CDSCO regulations, Class C devices require a Manufacturing License MD9 granted by the Central Licensing Authority, following detailed documentation, testing, and audits to ensure compliance with the Medical Device Rules (MDR) 2017.

Risk Classification and License Requirements for Class C Software

Class C devices are considered moderate to high risk. This includes software that performs diagnostic functions with potential patient impact. Obtaining an MD9 license (Form MD7 application) is mandatory for manufacturing such devices in India. Importers must obtain an MD15 license for market entry.

You can review the detailed Medical Device Classification to verify classifications and understand regulatory obligations.

Manufacturing License Process for Class C Software (MD9 License)

The manufacturing license process for Class C software involves multiple phases spanning approximately 4-5 months:

1. Test License (Form MD13): Initially, the manufacturer applies for a test license to conduct product testing. This typically takes 1.5-2 months.

2. Product Testing: Testing must be performed at CDSCO-approved laboratories. This validates the software’s safety and performance claims. Refer to the CDSCO Testing Laboratories List to select an authorized lab.

3. Document Preparation: Comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and QMS documents must be compiled.

4. License Application (Form MD7): Submit the MD9 license application through the CDSCO MD Online Portal.

5. Audit by CDSCO Inspectors: A detailed audit covering manufacturing premises, quality systems, and technical documentation will be conducted.

6. Query Resolution: Respond promptly to any queries from CDSCO or audit teams to avoid delays.

7. Grant of License (Form MD9): Upon successful compliance, the MD9 manufacturing license is issued.

For detailed guidance, consult our MD9 License Guide.

Manufacturing License Documents Required for Class C Software

Key documents needed for the MD9 license include:

• Company Constitution (Incorporation Certificate, PAN, GST)
• Proof of Ownership or Lease of Manufacturing Premises
• Qualifications and Experience of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF) detailing software design, development, and validation (Device Master File Guide)
• Plant Master File (PMF) describing manufacturing facilities (Plant Master File Guide)
• Essential Principles Checklist demonstrating conformity to MDR 2017
• Risk Management File outlining hazard analysis and mitigation (Risk Management)
• Test Reports from approved laboratories
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485:2016 certification

Meticulous preparation of these documents greatly minimizes audit findings and accelerates approval.

Import License Process for Class C Software (MD15 License)

If you plan to import the software into India, an MD15 license is required from the Central Licensing Authority. The process typically takes 5-6 months and includes:

• Document preparation as per CDSCO requirements
• Submission of application in Form MD14 via the CDSCO MD Online Portal
• Resolution of any queries from CDSCO
• Issuance of the MD15 import license

Supporting documents for import include:

• Valid Manufacturing License from country of origin
• Free Sale Certificate or Certificate of Market Authorization
• ISO 13485:2016 certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale license
• Company Constitution

Government fees vary by device class; for Class C, fees are approximately $3000 per site and$1500 per product.

Our Import License Guide provides a full checklist and insider tips.

Timeline and Processing Duration

Import license processing extends slightly longer to 5-6 months due to additional documentation and scrutiny.

Government Fees and Costs

For the MD9 manufacturing license of Class C devices:

• Application Fee: ₹50,000
• Per Product Fee: ₹1,000

Additional costs include testing laboratory fees (varies by scope), audit expenses, and professional consultancy if engaged.

For import licenses (MD15), fees are site and product-based, as detailed earlier.

Common Challenges and Solutions

Challenge: Insufficient or inconsistent documentation often leads to repeated queries and delays.

Solution: Utilize comprehensive checklists and templates, such as our Device Master File and Plant Master File guides, to ensure completeness and accuracy.

Challenge: Delays in product testing due to limited slots at government-approved labs.

Solution: Schedule testing early and consider multiple approved labs from the CDSCO Testing Laboratories list.

Challenge: Audit non-conformities related to inadequate QMS or technical staff qualifications.

Solution: Invest in ISO 13485:2016 certification and maintain detailed training records and qualifications.

Expert Consultation and Support

With over 25 years supporting 500+ companies in obtaining CDSCO licenses, we provide end-to-end consulting services including:

• Regulatory strategy and risk classification
• Documentation development and review
• Coordination with notified bodies and testing labs
• Application submission and query handling
• Audit preparedness coaching

Partnering with experts significantly streamlines your regulatory journey and reduces time-to-market.

Getting Started with Your CDSCO License Application

1. Assess your device classification using the CDSCO classification framework.

2. Prepare your Device Master File and Plant Master File leveraging our detailed guides.

3. Apply for the Test License (Form MD13) on the CDSCO MD Online Portal. Early application expedites testing.

4. Schedule product testing at an approved laboratory.

5. Compile all documentation including risk management, essential principles, and quality system files.

6. Submit your MD9 license application (Form MD7) via the CDSCO portal.

7. Prepare for and facilitate the CDSCO audit with thorough internal audits and mock inspections.

Starting early and following this structured approach ensures compliance and expedites approval for your supporting software for differential diagnosis with endoscopic imaging. For personalized assistance, reach out to our expert regulatory team to guide you seamlessly through the CDSCO licensing process.