CDSCO License for X-ray CT system for radiotherapy planning

Comprehensive Guide to CDSCO Licensing for X-ray CT Systems in Radiotherapy Planning (Class C Device)

When it comes to medical devices like the X-ray CT system specially configured for radiotherapy planning, regulatory compliance is not just a legal formality but a crucial assurance of safety and efficacy. This advanced device, classified as a Class C medical device by CDSCO, plays a vital role in determining the size and positioning of therapeutic radiation fields, directly impacting patient outcomes. Navigating the regulatory landscape for such a high-risk device requires expert knowledge, meticulous documentation, and a clear understanding of the CDSCO processes.

With over 25 years of experience assisting 500+ companies in securing CDSCO licenses, we provide you with a detailed roadmap tailored specifically for your X-ray CT system.

CDSCO Regulatory Framework for X-ray CT Systems in Radiotherapy

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules (MDR) 2017. Your device falls under the category of radiotherapy equipment and is classified as Class C due to its critical role in patient treatment planning and higher associated risk.

Class C devices require a manufacturing license known as the MD9 license, which is granted by the Central Licensing Authority (CLA) of CDSCO. This centralized process involves stringent assessments including testing, documentation reviews, and on-site audits.

Refer to the Medical Device Classification guide for clarity on device categorization.

Risk Classification and License Requirements for Class C Devices

• Risk Class: C
• License Type: MD9 Manufacturing License
• Governing Authority: Central Licensing Authority, CDSCO
• Application Form: MD7 for manufacturing, MD13 for initial test license
• Total Timeline: Approximately 4-5 months
• Fees: ₹50,000 per application + ₹1,000 per product

Manufacturing License Process for MD9 (Class C Devices)

1. Test License (Form MD13): Obtain a test license which allows you to produce sample devices for testing purposes. This step typically takes 1.5 to 2 months.

2. Product Testing: Samples must be tested at CDSCO-approved government laboratories. You can find the list of Testing Laboratories here.

3. Document Preparation: Compile comprehensive documents including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documents.

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

5. Audit by CDSCO Inspectors: The CLA conducts on-site inspections and audits your manufacturing facility to ensure compliance.

6. Query Resolution: Address any queries or observations raised by CDSCO or auditors promptly.

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

For a detailed walkthrough, our MD9 License Guide is a valuable resource.

Manufacturing License Documents Required for X-ray CT Systems

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

• Company Constitution: Incorporation certificate, partnership deed, or equivalent.
• Proof of Ownership: Ownership or lease documents of the manufacturing premises.
• Technical Staff Details: Qualification certificates and experience profiles of key personnel.
• Fire and Pollution NOCs: Required clearances from local authorities.
• Device Master File (DMF): Detailed description of device design, specifications, and manufacturing process. See our Device Master File guide.
• Plant Master File (PMF): Documentation covering manufacturing facility layout, equipment, and processes. More details in our Plant Master File guide.
• Essential Principles Checklist: Compliance with safety and performance standards.
• Risk Management File: Risk analysis, mitigation strategies, and post-market surveillance plans.
• Test Reports: Certificates from government approved labs validating device performance and safety.
• Labels and Instructions for Use (IFU): Device labeling, packaging inserts, and user manuals.
• Quality Management System Documentation: ISO 13485:2016 certification and relevant SOPs.

Import License Process for X-ray CT Systems (MD15 License)

If you plan to import the X-ray CT system, an MD15 import license issued by the Central Licensing Authority is mandatory.

Key steps include:

• Document preparation including manufacturing license, Free Sale Certificate, ISO 13485:2016, CE certificate, Device and Plant Master Files, and wholesale license.
• Application submission on the CDSCO MD Online Portal.
• Addressing queries and document clarifications.
• No test license is required for imports.

The process generally takes 5-6 months, with government fees structured as per device class.

For detailed guidance, see our Import License Guide.

Timeline and Processing Duration

Keep in mind, delays often occur due to incomplete documentation or slow response to queries. Planning ahead and thorough preparation can significantly reduce turnaround times.

Government Fees and Costs

• MD9 License Application Fee: ₹50,000 per application
• Per Product Fee: ₹1,000 per product
• Test License (MD13) Fee: Typically ₹5,000 (varies by state)
• Additional Costs: Laboratory testing fees (varies by test complexity), audit fees payable to notified bodies if applicable.

Investing in professional consultancy and pre-audit assessments can prevent costly rejections and delays.

Common Challenges and Solutions

• Incomplete Documentation: Ensure all files including DMF, PMF, and Risk Management files are detailed and up-to-date.
• Testing Delays: Coordinate early with CDSCO-approved labs; ensure sample devices meet testing criteria before submission.
• Audit Non-compliance: Conduct mock audits and train staff on regulatory requirements.
• Query Management: Respond promptly with clear, evidence-backed replies to avoid processing delays.

Our team has successfully helped clients overcome these hurdles by providing tailored support and compliance checklists.

Expert Consultation and Support

Navigating the CDSCO regulatory process for a Class C device like your X-ray CT system requires specialized expertise. We provide:

• Regulatory gap analysis
• Document preparation services
• Coordination with testing laboratories
• Audit readiness support
• Liaison with CDSCO officials

Our proven track record with 500+ companies ensures your application is robust and compliant.

Getting Started with Your CDSCO License Application

1. Assess your device classification and confirm the need for an MD9 license.
2. Initiate the test license application (Form MD13) through the CDSCO MD Online Portal.
3. Prepare comprehensive documentation including Device and Plant Master Files.
4. Arrange for product testing at CDSCO-approved labs.
5. Plan your internal quality and audit processes in advance.
6. Submit your MD9 license application (Form MD7) on the portal once testing is complete.
7. Engage with expert consultants to streamline responses to queries and prepare for on-site audits.

By following these actionable steps and leveraging expert support, you can confidently enter the Indian market with your X-ray CT system for radiotherapy planning.

For further assistance, explore our detailed MD9 License Guide and contact us to schedule a personalized consultation.