CDSCO License for Patient positioning device for breast diagnostic imaging and radiotherapy

Comprehensive Guide to CDSCO Licensing for Patient Positioning Device in Breast Diagnostic Imaging and Radiotherapy

Navigating the Indian regulatory landscape for medical devices can be complex, especially for specialized equipment like a patient positioning device designed for breast diagnostic imaging and radiotherapy. With over 25 years of experience and having successfully assisted 500+ companies, we provide you with an authoritative, step-by-step guide on obtaining the necessary CDSCO license for your Class B device.

Understanding the Patient Positioning Device and Its Regulatory Importance

A patient positioning device for breast diagnostic imaging and radiotherapy is critical in ensuring accurate and reproducible positioning of the breast and chest during imaging, image-guided surgery, interventional therapy, or radiotherapy. This precision directly impacts diagnostic quality and treatment efficacy, making regulatory compliance not just a legal mandate but a patient safety priority.

CDSCO Regulatory Framework for Radiotherapy Devices

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules (MDR) 2017, which classify devices based on risk. Your patient positioning device falls under Class B, indicating low to moderate risk. This classification necessitates obtaining a Manufacturing License (MD5) from the State Licensing Authority before marketing or manufacturing the device in India.

Risk Classification and License Requirements for Class B Devices

Class B devices, like your patient positioning system, require:

• A Test License (MD13) to initiate product testing,
• Product testing at government-approved laboratories,
• A thorough audit by a notified body,
• Submission of extensive documentation, and
• Compliance with Indian regulatory standards.

For more insight on device classification, refer to our Medical Device Classification guide.

Step-by-Step Manufacturing License Process (MD5) for Your Device

1. Apply for Test License (Form MD13):
   • Duration: 1.5 to 2 months
   • Purpose: Enables testing of your device samples at CDSCO-approved labs.
2. Product Testing:
   • Conduct tests in government-recognized laboratories. Find approved labs on the CDSCO Testing Laboratories list.
3. Documentation Preparation:
   • Prepare comprehensive documents including Device Master File (DMF), Plant Master File (PMF), Risk Management File, Quality Management System (QMS) documentation, and others.
4. Application Submission for MD5 License (Form MD3):
   • Submit the completed application through the CDSCO MD Online Portal.
5. Audit by Notified Body:
   • The notified body conducts a facility and QMS audit. Check the list of notified bodies for your audit partner.
6. Query Resolution:
   • Address any queries raised by the department or notified body promptly.
7. License Grant:
   • Once compliant, the State Licensing Authority grants the MD5 license.

For a detailed walkthrough, our MD5 License Guide is an excellent resource.

Manufacturing License Documents Required for Class B Devices

Your application must include:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualifications and Experience
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF) detailing design, specifications, and manufacturing processes (Learn more here)
• Plant Master File (PMF) describing manufacturing facilities (PMF guide)
• Essential Principles Checklist confirming compliance with MDR 2017
• Risk Management File showcasing hazard analysis and mitigation (Risk Management insights)
• Test Reports from approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, typically ISO 13485:2016 certification

Import License Process (MD15) for Patient Positioning Devices

If you plan to import this device into India, an MD15 Import License from the Central Licensing Authority is mandatory. The process differs slightly:

• No test license is required, but robust documentation including Manufacturing License, Free Sale Certificate, and ISO certificates must be submitted.
• Apply on the CDSCO MD Online Portal using Form MD14.
• The usual processing timeline is 5 to 6 months.

For detailed import licensing requirements, consult our Import License Guide.

Timeline and Processing Duration Overview

Government Fees and Costs

For the MD5 manufacturing license of a Class B device like yours:

• Application Fee: ₹5,000 per application
• Product Fee: ₹500 per product

Additional costs will include:

• Testing fees charged by government-approved labs (varies by test scope)
• Audit fees charged by notified bodies
• Consultant fees if you engage regulatory experts

Being prepared financially and operationally with these figures in mind helps avoid delays.

Common Challenges and Practical Solutions

• Incomplete Documentation: Many applicants miss submitting a full Plant Master File or Risk Management File. We recommend using our detailed templates and guides to ensure completeness.
• Delayed Testing: Government labs often have backlogs. Submit your test license application early and consider parallel activities like document preparation.
• Audit Non-Compliances: Ensure your Quality Management System aligns with ISO 13485:2016 and that your manufacturing practices meet notified body expectations.
• Query Resolution Delays: Assign a dedicated regulatory affairs professional to respond swiftly to CDSCO queries.

Expert Consultation and Support

With over two decades of regulatory consulting, we assist manufacturers and importers by:

• Preparing and reviewing all documentation
• Coordinating with testing laboratories and notified bodies
• Guiding through audit preparedness
• Streamlining query responses
• Offering post-license compliance advice

Our track record includes enabling clients to achieve license grants within the shortest possible timelines while ensuring 100% compliance.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device is Class B using the MDR guidelines.
2. Register on the CDSCO MD Online Portal: Start your application process by creating an account at the CDSCO MD Online Portal.
3. Prepare Your Test License Application: Gather initial documents and apply for the MD13 test license.
4. Engage a Notified Body Early: Identify and contact a notified body from the official list to schedule your audit.
5. Compile Documentation: Utilize our comprehensive document templates for DMF, PMF, Risk Management, and QMS.
6. Plan Your Timelines: Account for 3-4 months from test license submission to final MD5 approval.

By following this roadmap and leveraging expert support, you can confidently navigate the CDSCO licensing process for your patient positioning device and successfully enter the Indian market.

For personalized assistance tailored to your device and business model, please contact our regulatory consultancy team.

Empower your medical device journey in India with compliance, confidence, and clarity.