CDSCO License for Information collating software for radiotherapy

Comprehensive Guide to CDSCO Licensing for Information Collating Software for Radiotherapy (Class C)

Navigating the regulatory landscape in India for medical devices, especially software used in radiotherapy, demands precision and thorough understanding. As experts with over 25 years of experience and having guided 500+ companies through the CDSCO licensing process, we provide you with a detailed roadmap to obtain the MD9 manufacturing license for your Class C Information Collating Software for Radiotherapy.

Understanding Your Device and Its Regulatory Importance

Your device, an Information Collating Software for Radiotherapy, plays a critical role in collating irradiation parameters specified by radiation planning software alongside real-time irradiation conditions of X-ray radiotherapy equipment. Given its direct impact on patient safety and treatment efficacy, it falls under Class C as per the CDSCO classification, indicating a moderate to high risk.

This classification aligns with the CDSCO medical device classification guidelines, ensuring that such software meets stringent regulatory controls before entering the Indian market.

CDSCO Regulatory Framework for Software-Based Medical Devices

The Central Drugs Standard Control Organization (CDSCO) regulates software medical devices under the Medical Devices Rules, 2017, amended periodically. Your software is recognized under Notification 29/Misc./03/2020-DC (198) dated 13.9.2021, which specifically addresses regulatory requirements for software devices in radiotherapy.

Regulatory compliance involves:

• Risk classification (Class C for your device)
• Obtaining a manufacturing license (MD9) from the Central Licensing Authority
• Ensuring conformity with essential principles including software validation, risk management, and quality systems

Risk Classification and License Requirements for Class C Software

Class C devices require a manufacturing license known as the MD9 license. This license is issued by the CDSCO Central Licensing Authority because of the device's higher risk profile and potential impact on patient safety.

The MD9 license process is more rigorous than Class A/B devices, incorporating extensive product testing, documentation scrutiny, and inspection.

Manufacturing License Process (MD9) for Class C Devices

The MD9 licensing process typically spans 4 to 5 months and involves these key steps:

1. Test License Application (Form MD13): Before applying for MD9, you must secure a test license to conduct necessary product testing. This takes approximately 1.5 to 2 months.

2. Product Testing: Testing must be performed at CDSCO-approved government laboratories. Testing ensures software safety, performance, and compliance with applicable standards. You can find the list of Testing Laboratories here.

3. Document Preparation: Compile comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and Quality Management System (QMS) documents. Our detailed Device Master File guide and Plant Master File guide can help streamline this process.

4. Application Submission (Form MD7): Submit your application with all supporting documents through the CDSCO MD Online Portal.

5. Audit and Inspection: CDSCO inspectors will conduct audits to verify compliance with QMS and manufacturing standards.

6. Query Resolution: Address any queries raised by CDSCO or notified bodies promptly to avoid delays.

7. Grant of License (Form MD9): Upon successful completion of all steps, your manufacturing license will be granted.

Manufacturing License Documents Required for MD9 Application

To ensure a smooth application process, prepare the following documents meticulously:

• Company Constitution Documents: Incorporation certificate, partnership deed, or equivalent
• Proof of Ownership or Lease of Premises: Rental agreement or ownership documents
• Technical Staff Qualifications: CVs and experience details of key technical personnel
• Fire NOC and Pollution Control NOC: Required clearances for facility safety and environmental compliance
• Device Master File (DMF): Detailed description of the software, architecture, intended use, and validation reports
• Plant Master File (PMF): Details of manufacturing facility and processes
• Essential Principles Checklist: Demonstrating compliance with applicable standards
• Risk Management File: Documented risk analysis and mitigation strategies following ISO 14971 principles. Refer to our Risk Management guide for best practices.
• Test Reports: From CDSCO-approved testing laboratories
• Labels and Instructions for Use (IFU): Clear and compliant labeling and user manuals
• Quality Management System (QMS) Documents: ISO 13485:2016 certification and related procedures

Import License Process (MD15) for Software Devices

If you plan to import your radiotherapy software into India, an MD15 import license is mandatory. The process is managed by the Central Licensing Authority and takes approximately 5 to 6 months.

Unlike manufacturing licenses, no test license (MD13) is required before MD15 application. However, the documentation requirements are stringent:

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master and Plant Master Files
• Wholesale License (if applicable)
• Company Constitution

Government fees vary based on risk class and number of products. For Class C, fees are typically $3000 per site and$1500 per product.

You can submit your application using the CDSCO MD Online Portal.

Timeline and Processing Duration Summary

Government Fees and Costs Breakdown

• MD9 Manufacturing License: ₹50,000 per application + ₹1,000 per product
• Test License (MD13): Fees vary by state, typically ₹5,000
• Import License (MD15): $3,000 per site +$1,500 per product for Class C devices

Budgeting for these costs upfront helps avoid surprises and ensures uninterrupted regulatory progress.

Common Challenges and Practical Solutions

• Delay in Testing: Many applicants face delays obtaining test reports from government-approved labs. Planning early, booking slots with labs in advance, and preparing test samples meticulously can mitigate this.

• Incomplete Documentation: Missing or insufficient technical files often trigger queries. Using checklists and expert consultation ensures completeness.

• Audit Non-Compliance: Audits require fully implemented QMS and documented processes. Conduct internal audits and mock inspections to prepare your team.

• Query Resolution Delays: Prompt, clear, and well-documented responses to CDSCO queries accelerate approval.

Expert Consultation and Support

With over 25 years of experience and a track record of assisting 500+ companies, our regulatory consultants specialize in:

• Document preparation and review
• Internal audit and gap analysis
• Liaison with CDSCO and notified bodies
• Training your team on compliance requirements

Partnering with experts significantly improves your chances of swift licensing.

Getting Started with Your CDSCO License Application

1. Determine Device Classification: Confirm Class C designation for your software using CDSCO guidelines.
2. Prepare Documentation: Begin assembling your Device Master File, Risk Management File, and QMS documents.
3. Apply for Test License (MD13): Submit online via the CDSCO MD Online Portal to initiate testing.
4. Schedule Product Testing: Coordinate with approved labs early to book testing slots.
5. Audit Preparation: Develop and implement QMS protocols aligned with ISO 13485:2016.
6. Seek Expert Guidance: Engage experienced consultants to review your application before submission.

By following these practical steps, you set a strong foundation for a successful MD9 license grant for your Information Collating Software for Radiotherapy.

For detailed assistance and tailored support, contact our regulatory experts today and leverage our extensive experience to bring your innovative software to the Indian market compliantly and efficiently.