CDSCO License for Computer- Assisted Diagnostic Software For Lesions Suspicious For Cancer

Comprehensive Guide to CDSCO Licensing for Computer-Assisted Diagnostic Software (Class C Medical Device)

Computer-Assisted Diagnostic Software for lesions suspicious for cancer represents a cutting-edge class of medical devices that assist clinical users in characterizing suspicious lesions on acquired medical images. This software plays a critical role in enhancing diagnostic accuracy, making it an indispensable tool in modern oncology and radiology workflows. Given its significant impact on patient care and diagnosis, it falls under Class C risk classification in India’s regulatory framework.

Navigating the licensing requirements set forth by the Central Drugs Standard Control Organization (CDSCO) for such software devices can be complex. With over 25 years of experience and having supported more than 500 companies in securing CDSCO licenses, we provide you with a detailed, actionable roadmap to successfully obtain your MD9 manufacturing license tailored specifically for Class C medical device software.

CDSCO Regulatory Framework for Computer-Assisted Diagnostic Software

India’s medical device regulations have evolved to incorporate software as a medical device (SaMD), acknowledging their specialized risk profiles and intended clinical uses. Your diagnostic software is regulated under the CDSCO's framework following the notification number 29/Misc./03/2020-DC (198) dated 13.09.2021, which explicitly includes software aiding lesion characterization in cancer diagnostics.

The regulatory oversight ensures the device meets safety, quality, and performance standards before it enters the Indian market to protect patient health and support clinical efficacy.

Risk Classification and License Requirements for Class C Software

According to CDSCO’s classification:

• Class A & B devices are low to moderate risk.
• Class C devices, such as computer-assisted diagnostic software, are moderate to high risk due to their potential clinical impact.
• Class D covers high-risk devices like implantables.

Your diagnostic software is classified as Class C, mandating an MD9 manufacturing license issued by the Central Licensing Authority.

You can verify device classification specifics on the Medical Device Classification guide.

Manufacturing License Process for Class C Devices (MD9 License)

The MD9 license approval process is detailed and rigorous, reflecting the criticality of the device. Here's a step-by-step overview:

1. Test License (Form MD13) Application:

   • Duration: 1.5 to 2 months
   • Purpose: Allows initial testing and evaluation of the software before full license application.

2. Product Testing:

   • Testing must be conducted at CDSCO-approved testing laboratories to validate performance and safety.
   • Refer to the Testing Laboratories list for authorized labs.

3. Document Preparation:

   • Compile comprehensive technical documentation including Device Master File, Plant Master File, Risk Management File, and essential principles checklist.

4. MD9 License Application (Form MD7):

   • Submit your application via the CDSCO MD Online Portal.

5. Inspection and Audit:

   • CDSCO inspectors conduct audits to verify compliance with QMS and technical requirements.

6. Query Resolution:

   • Address any queries or deficiencies raised by CDSCO during the review process.

7. License Grant (Form MD9):

   • Upon satisfactory review, the manufacturing license is granted.

For a detailed walkthrough, explore our MD9 License Guide.

Essential Documents Required for MD9 License Application

The following documentation is mandatory for your Class C software device:

• Company Constitution Documents: Proof of company registration and legal entity.
• Proof of Ownership or Lease of Manufacturing Premises: Establishes control over manufacturing site.
• Technical Staff Qualification Documents: Details of personnel responsible for manufacturing and quality.
• Fire Safety and Pollution NOCs
• Device Master File (DMF): Comprehensive technical dossier covering design, development, and software validation. Our Device Master File guide offers best practices.
• Plant Master File (PMF): Details of manufacturing site, equipment, and processes. See our Plant Master File Guide for preparation tips.
• Essential Principles Checklist: Compliance with Indian Medical Device Rules (IMDR).
• Risk Management File: Documentation of hazard analysis and mitigation strategies. Refer to our Risk Management guide for implementation.
• Test Reports: Validated test results from CDSCO-approved labs.
• Labels and Instructions for Use (IFU): Clear, compliant labeling and user instructions.
• Quality Management System (QMS) Documents: ISO 13485:2016 certification and related SOPs.

Attention to detail in these documents significantly reduces back-and-forth queries and accelerates approval.

Import License Process (MD15) for Class C Devices

If you plan to import this software into India, an MD15 import license from the Central Licensing Authority is required.

Key highlights:

• No test license needed beforehand.
• Mandatory submission of manufacturing license from the country of origin.
• Required documents include Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, wholesale license, and company constitution.
• Application via the CDSCO MD Online Portal.

The process generally takes 5-6 months.

For a detailed overview, visit our Import License Guide.

Timeline and Processing Duration

Planning accordingly and preparing documents meticulously can help meet these timelines.

Government Fees and Costs for MD9 License

• Application Fee: ₹50,000 per application
• Per Product Fee: ₹1,000 per product
• Additional costs include testing fees at government-approved labs and audit fees if engaging notified bodies.

Budgeting for these expenses upfront will ensure smooth financial planning.

Common Challenges and Practical Solutions

Challenge 1: Documentation Gaps

• Solution: Utilize our detailed checklists for Device and Plant Master Files to ensure completeness.

Challenge 2: Delays in Testing

• Solution: Select CDSCO-approved testing labs early – see the Testing Laboratories list.

Challenge 3: Audit Non-Compliance

• Solution: Conduct internal mock audits and review QMS thoroughly before CDSCO inspection.

Challenge 4: Query Overload

• Solution: Maintain clear communication and swift response mechanisms with CDSCO officers.

Expert Consultation and Support

With a legacy of assisting over 500 companies, our consultants specialize in:

• Regulatory strategy tailored for Class C software devices
• Document preparation and gap analysis
• Liaison with CDSCO authorities and notified bodies
• End-to-end project management from test license to grant of MD9 license

Engaging expert support can significantly reduce approval timelines and improve submission quality.

Getting Started with Your CDSCO License Application

1. Initiate Internal Assessment: Confirm your software device’s classification and scope.
2. Compile Required Documents: Start with company constitution, premises proofs, and technical staff details.
3. Apply for Test License (MD13): Submit via the CDSCO MD Online Portal to begin product testing.
4. Engage Approved Testing Labs: Schedule timely testing to avoid bottlenecks.
5. Prepare Technical Files: Utilize our Device and Plant Master File guides to develop robust documentation.
6. Plan Audit Readiness: Ensure your quality system and manufacturing site comply with CDSCO standards.
7. Submit MD9 Application (Form MD7): Once testing and documents are ready, apply for the manufacturing license.

Taking these practical steps with expert guidance will empower your company to successfully navigate the regulatory pathway for your computer-assisted diagnostic software and enter the Indian market confidently.

For personalized assistance or to begin your application process, connect with our regulatory experts who have a proven track record of accelerating CDSCO approvals for advanced medical software devices.