CDSCO License for Software for radiation planning

Comprehensive Guide to CDSCO Licensing for Software for Radiation Planning (Class C Medical Device)

Navigating the regulatory landscape for medical devices in India can be complex, especially for specialized software like radiation planning tools. These software solutions are critical in oncological treatments, calculating and displaying radiation treatment areas and internal dose distributions based on CT imaging and other diagnostic inputs. As a trusted regulatory consultancy with over 25 years of experience and having assisted 500+ companies, we provide you with a detailed roadmap to secure your CDSCO license efficiently.

CDSCO Regulatory Framework for Radiation Planning Software

The Central Drugs Standard Control Organization (CDSCO) governs the import and manufacture of medical devices in India. Software for radiation planning falls under the medical device category, notified under 29/Misc./03/2020-DC (198) dated 13.9.2021. Given its critical role in treatment planning, it is classified as a Class C device based on potential risk to patients.

This means the licensing and compliance requirements are overseen by the Central Licensing Authority, involving stringent documentation, testing, and audits.

Risk Classification and License Requirements for Class C Software

According to the CDSCO medical device classification guidelines, Class C devices represent moderate to high risk to patients. Radiation planning software, due to its direct influence on treatment doses, demands rigorous evaluation.

For Class C devices, the applicable manufacturing license is the MD9 license, applied via Form MD7. Importers must obtain the MD15 import license using Form MD14. These licenses ensure compliance with Indian regulations and adherence to safety and performance standards.

Manufacturing License Process for Class C Software (MD9 License)

The manufacturing license process for a Class C radiation planning software involves the following steps:

1. Test License (Form MD13): Before manufacture, you must obtain a test license, allowing you to conduct product testing in CDSCO-recognized laboratories.
2. Product Testing: The software must be tested for safety, performance, and compliance with the Essential Principles. Testing labs can be found on the CDSCO Testing Laboratories list.
3. Document Preparation: Compile comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.
4. Application Submission: File Form MD7 on the CDSCO MD Online Portal, paying the requisite fees.
5. Audit by CDSCO Inspectors: The Central Licensing Authority will conduct an audit of manufacturing premises and quality systems.
6. Query Resolution: Address any observations or queries raised during audit or document review.
7. Grant of MD9 License: Upon satisfactory compliance, the license is granted.

Manufacturing License Documents Required for MD9

For your radiation planning software manufacturing license, the following documents must be ready:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File detailing software architecture, validation, and verification processes (Device Master File Guide)
• Plant Master File describing manufacturing processes and infrastructure (Plant Master File Guide)
• Essential Principles Checklist demonstrating compliance with safety and performance standards
• Risk Management File documenting hazard analysis and risk mitigation (Risk Management)
• Test Reports from CDSCO approved laboratories
• Labels and Instructions for Use (IFU) specific to the software
• Quality Management System (QMS) documentation; ISO 13485:2016 certification is highly recommended

Import License Process for Radiation Planning Software (MD15 License)

If you intend to import the software rather than manufacture it locally, you must obtain an MD15 import license by following these steps:

1. Document Preparation: Collect all required documents including manufacturing license from the country of origin, free sale certificate, and quality certifications.
2. Application Submission: Submit Form MD14 via the CDSCO MD Online Portal.
3. Review and Queries: CDSCO will review your application and may raise queries for additional information.
4. Grant of MD15 License: After satisfactory evaluation, the import license is issued.

Import License Documents Required

• Valid Manufacturing License from exporting country
• Free Sale Certificate from exporting country’s regulatory authority
• ISO 13485:2016 Certificate
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution

Timeline and Processing Duration

Understanding the timeline helps you plan effectively:

• MD9 Manufacturing License: Approximately 4-5 months total.

  • Test License (MD13): 1.5-2 months
  • Testing and Reports: 1-1.5 months
  • Application, Audit, and License Grant: 1.5-2 months

• MD15 Import License: Approximately 5-6 months total.

These timelines assume complete and accurate documentation and prompt resolution of queries.

Government Fees and Costs

The fee structure for Class C devices is as follows:

• MD9 License: Rs 50,000 per application + Rs 1,000 per product
• MD15 Import License: Rs 3,000 per site + Rs 1,500 per product

Additional costs include testing fees charged by government-approved labs and audit-related expenses.

Common Challenges and Solutions

• Incomplete Documentation: Many applicants struggle with compiling comprehensive Device and Plant Master Files. We recommend referring to our Device Master File Guide and Plant Master File Guide for detailed instructions.
• Test Lab Delays: Testing in government-approved labs can be time-consuming due to capacity constraints. Early scheduling and continuous follow-up with labs listed on the CDSCO Testing Laboratories portal can mitigate delays.
• Audit Non-Compliance: Lack of preparedness during CDSCO audits often leads to delays. Conduct internal audits and gap analyses before official inspections.
• Query Resolution: Respond promptly and comprehensively to any queries from CDSCO or notified bodies to avoid prolonged processing.

Expert Consultation and Support

Our team has supported over 500 companies in successfully obtaining CDSCO licenses for complex Class C software devices. We provide end-to-end assistance including:

• Gap analysis of technical and regulatory documentation
• Preparation and review of Device and Plant Master Files
• Coordination with testing laboratories
• Audit readiness training and mock inspections
• Application filing and query management

Getting Started with Your CDSCO License Application

To initiate your CDSCO license application for the radiation planning software:

1. Assess Your Product Classification: Confirm Class C status by reviewing the Medical Device Classification.
2. Prepare Detailed Documentation: Start compiling your Device Master File, Plant Master File, and QMS documents.
3. Apply for Test License (MD13): Submit through the CDSCO MD Online Portal to begin product testing.
4. Plan for Testing and Audit: Coordinate with CDSCO-approved testing labs and schedule your audit with the Central Licensing Authority.
5. Consult Experts: Engage with regulatory consultants experienced in MD9 licensing to streamline your process.

Embarking on the CDSCO licensing journey with a clear, informed approach significantly enhances your chances of timely approval. Reach out to us for personalized support tailored to your radiation planning software, and let's make your entry into the Indian market seamless and successful.