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CDSCO License for Fluorescent scanner

Medical Device Information

Device Class
Class C

Intended Use

A fluorescent scanner is a device intended to measure the induced fluorescent radiation in the body by exposing the body to certain x-rays  or low-energy gamma rays.

Manufacturing License
MD9
Import License
MD15
CDSCO License for Fluorescent scanner

Comprehensive Guide to CDSCO Licensing for Fluorescent Scanners (Class C Medical Device)

As specialists with over 25 years of experience in medical device regulatory affairs, having supported more than 500 manufacturers and importers, we understand the complexities of navigating CDSCO licensing in India. Fluorescent scanners, classified as Class C devices under the CDSCO regulatory framework, demand meticulous documentation and compliance due to their interventional radiology application and inherent risks.

Understanding Fluorescent Scanners and Their Regulatory Significance

A fluorescent scanner is designed to measure induced fluorescent radiation within the body by exposing tissues to specific x-rays or low-energy gamma rays. Given its role in interventional radiology, it carries a moderate to high risk, necessitating a Class C classification as per the CDSCO medical device classification. This classification impacts the licensing pathway and regulatory scrutiny.

CDSCO Regulatory Framework for Fluorescent Scanners

The Central Drugs Standard Control Organization (CDSCO) governs medical device approvals in India. For Class C devices like fluorescent scanners, the manufacturing license (MD9) is issued by the Central Licensing Authority. The framework encompasses multiple stages including test licensing, product testing, documentation, audit inspections, and final licensing.

Risk Classification and Licensing Requirements for Fluorescent Scanners

  • Device Risk Class: C
  • Applicable License: Manufacturing License MD9 (Form MD7) for domestic manufacturing
  • Regulatory Authority: Central Licensing Authority, CDSCO
  • Process Duration: Approximately 4-5 months

This process ensures thorough assessment of safety and efficacy given the device’s use in sensitive radiological interventions.

Step-by-Step Manufacturing License Process for MD9

  1. Test License Application (Form MD13):
    • Initial step requiring application for a test license enabling sample production for testing.
    • Processing time: 1.5-2 months.
  2. Product Testing:
  3. Documentation Preparation:
    • Compile comprehensive technical and quality documentation.
  4. Application Submission (Form MD7):
  5. Audit Inspection:
    • CDSCO inspectors conduct on-site audits to verify compliance.
  6. Query Resolution:
    • Address any queries raised by inspectors or CDSCO.
  7. License Granting:
    • Upon satisfactory compliance, the MD9 license is granted.

Essential Documents Required for MD9 Manufacturing License

  • Company Constitution: Certificate of Incorporation, MOA/AOA.
  • Proof of Premises Ownership or Lease: Valid property documents.
  • Technical Staff Qualifications: Details of qualified personnel.
  • No Objection Certificates (NOCs): Fire safety, pollution control.
  • Device Master File (DMF): Detailed device specifications and manufacturing process. For guidance, see our Device Master File guide.
  • Plant Master File (PMF): Manufacturing facility details; refer to our Plant Master File guide.
  • Essential Principles Checklist: Compliance with Indian regulations.
  • Risk Management File: Demonstration of risk assessment and mitigation strategies. Learn more about implementation in our Risk Management resource.
  • Test Reports: From government-approved testing laboratories.
  • Labeling and Instructions for Use (IFU): Compliant with CDSCO requirements.
  • Quality Management System (QMS) Documents: ISO 13485 certification and SOPs.

Import License Process (MD15) for Fluorescent Scanners

For companies intending to import fluorescent scanners into India, the CDSCO MD15 license is mandatory. This process is handled entirely by the Central Licensing Authority and typically takes 5-6 months. Unlike manufacturing, no test license is required; however, rigorous documentation such as Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, and wholesale licenses must be provided.

Import License Documents Required

  • Manufacturing License from the manufacturing country.
  • Free Sale Certificate.
  • ISO 13485:2016 Certificate.
  • CE Certificate or equivalent.
  • Device Master File and Plant Master File.
  • Wholesale license in India.
  • Company Constitution.

Government fees vary by risk class and product count. For Class C devices, fees are approximately 3000persiteand3000 per site and 1500 per product.

Timeline and Processing Duration

Process StepDuration
Test License (MD13)1.5-2 months
Product Testing3-4 weeks
Documentation Preparation3-4 weeks
Manufacturing License (MD9)2-3 months
Audit and Query Resolution1-2 months
Total Time4-5 months

These timelines are approximate and may vary depending on the quality of submission and CDSCO workload.

Government Fees and Costs for MD9 License

  • Application Fee: ₹50,000 per application.
  • Per Product Fee: ₹1,000.

Additional costs include laboratory testing fees and audit expenses. Budgeting for these upfront can prevent surprises.

Common Challenges and Practical Solutions

  • Delayed Test Reports: Engage with CDSCO-approved labs early to schedule testing and avoid bottlenecks.
  • Incomplete Documentation: Use comprehensive checklists and templates to ensure all files such as DMF, PMF, and Risk Management are complete.
  • Audit Non-compliance: Conduct pre-audit internal reviews and training to ensure readiness.
  • Query Management: Maintain prompt and clear communication with CDSCO to resolve queries swiftly.

Expert Consultation and Support for Fluorescent Scanner Licensing

Our extensive experience with 500+ successful CDSCO licenses allows us to offer tailored consulting services, from documentation preparation to audit support. We help streamline the process, minimize delays, and ensure compliance, leveraging our knowledge of CDSCO nuances.

Getting Started with Your CDSCO License Application for Fluorescent Scanners

  1. Assess Device Classification: Confirm Class C status with CDSCO guidelines.
  2. Plan Test Licensing and Sampling: Initiate test license application (Form MD13) via the CDSCO MD Online Portal.
  3. Engage Accredited Testing Labs: Schedule product testing early.
  4. Prepare Complete Documentation: Utilize our Device Master File guide and Plant Master File guide for comprehensive file creation.
  5. Submit Manufacturing License Application (Form MD7): Through the CDSCO MD Online portal after test license and testing are complete.
  6. Prepare for Audit: Conduct internal mock audits to ensure compliance.
  7. Respond Promptly to Queries: Maintain an organized process for query resolution.

By following these actionable steps, manufacturers and importers can reduce approval time and confidently enter the Indian market with their fluorescent scanners. For detailed assistance, connect with our regulatory experts who specialize in CDSCO medical device licensing.


For further insights and assistance, explore our MD9 License Guide and start your seamless CDSCO licensing journey today.

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Tails Azimuth
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