CDSCO License for Software for radiotherapy QAQC planning

Introduction to Software for Radiotherapy QAQC Planning and Regulatory Importance

Software for radiotherapy QAQC planning plays a crucial role in ensuring patient safety by verifying the accuracy of radiotherapy treatment plans. Specifically, this software recalculates dose and monitor units (MU) to validate radiotherapy plans generated by planning systems. Given its critical role in patient care and potential impact on treatment outcomes, it falls under Class C as per CDSCO’s medical device classification, indicating moderate to high risk.

Navigating the CDSCO regulatory framework for such software demands a detailed understanding of process nuances, timelines, and documentation. With 25+ years of experience and having assisted over 500 companies, we provide you with precise, actionable insights to successfully obtain your MD9 license for this device category.

CDSCO Regulatory Framework for Radiotherapy QAQC Software

In India, software intended for medical use, especially those involved in radiotherapy QAQC, are regulated under the medical device rules notified by CDSCO. The applicable notification for this software is 29/Misc./03/2020-DC (198), dated 13.9.2021, which classifies this device as Class C. This classification mandates that the licensing and inspection process be managed by the Central Licensing Authority.

Risk Classification and License Requirements for Radiotherapy QAQC Software

• Risk Class: Class C
• Applicable License: MD9 Manufacturing License (for manufacturing in India) or MD15 Import License (for importing)
• Authority: Central Licensing Authority (CDSCO)

Class C devices require stringent compliance with quality management systems, clinical evaluation, and risk management standards. For software devices, ensuring compliance with IEC 62304 (software lifecycle processes) and ISO 13485:2016 is critical.

Manufacturing License Process (MD9) for Class C Radiotherapy QAQC Software

Obtaining an MD9 license involves several stages:

1. Test License (Form MD13): Before applying for the MD9 license, you must obtain a test license valid for 3-6 months to conduct product testing in CDSCO-approved laboratories. This typically takes 1.5 to 2 months to process.

2. Product Testing: Get your software tested at government-approved testing laboratories for compliance with relevant standards such as IEC 62304 and IEC 60601-1 for software and medical electrical equipment safety. A list of approved testing laboratories can be found on the CDSCO portal.

3. Document Compilation and Application: Prepare and submit your MD9 license application on Form MD7 via the CDSCO MD Online Portal. This includes comprehensive technical documentation, quality management records, and test reports.

4. Inspection and Audit: CDSCO officials will conduct a thorough inspection of your manufacturing facility to verify compliance with regulatory requirements.

5. Query Resolution: Address any queries raised by the CDSCO office or inspectors promptly.

6. Grant of License: Upon satisfactory review and inspection, the MD9 license will be granted via Form MD9.

Manufacturing License Documents Required for Class C Software

For your radiotherapy QAQC software, ensure you have the following documents prepared:

• Company constitution and incorporation certificates
• Proof of ownership or lease of manufacturing premises
• Details and qualifications of technical staff
• Fire and pollution NOCs
• Device Master File (DMF): Detailed technical documentation of the software design, development, validation, and updates. Our Device Master File guide offers detailed insights.
• Plant Master File (PMF): Description of your manufacturing environment and controls. Refer to our Plant Master File guide.
• Essential Principles Checklist confirming compliance with medical device regulations
• Risk Management File detailing hazard analysis, risk evaluation, and mitigation strategies aligned with ISO 14971. Learn more about risk management.
• Complete test reports from CDSCO-approved labs
• Product labeling and Instructions for Use (IFU)
• Quality Management System (QMS) documentation demonstrating adherence to ISO 13485:2016

Import License Process (MD15) for Radiotherapy QAQC Software

If you plan to import the software rather than manufacture it locally, the MD15 import license is applicable:

1. Document Preparation: Gather all requisite documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate (if applicable), Device and Plant Master Files, and wholesale license.

2. Application Submission: Apply on Form MD14 through the CDSCO MD Online Portal.

3. Review and Queries: The Central Licensing Authority reviews your application and may raise queries.

4. Grant of License: On satisfactory completion of review, MD15 import license is issued.

Import License Documents Required for Class C Software

• Valid manufacturing license from the country of origin
• Free Sale Certificate
• ISO 13485:2016 certification
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale license
• Company constitution and incorporation certificates

Timeline and Processing Duration for Class C Radiotherapy QAQC Software

Government Fees and Costs for MD9 License

• Application fee: ₹50,000 per application
• Product fee: ₹1,000 per product
• Additional costs may include testing fees charged by laboratories (vary by lab and test scope)

Budgeting for these fees early in the process will help avoid delays.

Common Challenges and Solutions

Challenge 1: Delays in product testing due to insufficient documentation or non-compliance.

• Solution: Pre-assess your software against IEC 62304 and other relevant standards. Engage accredited labs early and ensure submission of complete technical files.

Challenge 2: Incomplete or inconsistent documentation leading to audit queries.

• Solution: Maintain updated and harmonized Device and Plant Master Files. Use templates aligned with CDSCO expectations.

Challenge 3: Misunderstanding classification leading to incorrect license application.

• Solution: Confirm device classification through the official CDSCO classification resource or expert consultation. For detailed classification, refer to our Medical Device Classification guide.

Expert Consultation and Support

Navigating the MD9 licensing process for Class C radiotherapy QAQC software requires expertise in regulatory compliance, technical documentation, and audit readiness. Our consultancy has successfully supported over 500 clients, ensuring smooth approvals through meticulous preparation and proactive query handling.

We offer:

• Gap analysis of your existing documentation
• Preparation of Device and Plant Master Files
• Support for risk management and QMS compliance
• Coordination with CDSCO officials and notified bodies
• Assistance with testing and audit processes

Getting Started with Your CDSCO License Application

1. Evaluate Device Classification: Confirm your software’s classification as Class C.
2. Initiate Test License Application: Submit Form MD13 on the CDSCO MD Online Portal to obtain a test license.
3. Prepare Technical Documentation: Compile your Device Master File, Plant Master File, test protocols, risk management files, and QMS documents.
4. Select Testing Laboratory: Identify and engage a CDSCO-approved testing laboratory early. You can access the list of testing laboratories online.
5. Plan for Audit: Prepare your manufacturing site and documentation for the CDSCO inspection.
6. Apply for MD9 License: Once testing is complete, submit Form MD7 with all supporting documents.
7. Engage Expert Help: To avoid pitfalls and reduce processing time, consider expert regulatory consultancy support.

By following these steps and leveraging experienced guidance, you can efficiently navigate the regulatory pathway and bring your radiotherapy QAQC software to the Indian market with confidence.