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CDSCO License for Wound auto fluorescence imaging device

Medical Device Information

Device Class
Class B

Intended Use

A wound auto fluorescence imaging device is a tool to view auto fluorescence images from skin wounds that are exposed to an excitation light. The device is not intended to provide quantitative or diagnostic information.

Manufacturing License
MD5
Import License
MD15
CDSCO License for Wound auto fluorescence imaging device

Comprehensive Guide to CDSCO Licensing for Wound Auto Fluorescence Imaging Device

As an expert medical device regulatory consultancy with over 25 years of experience and 500+ successful CDSCO license approvals, we understand the critical importance of regulatory compliance for medical devices like the wound auto fluorescence imaging device. This device, categorized under dermatological and plastic surgery and classified as Class B, requires a meticulous approach to obtain the necessary CDSCO manufacturing license (MD5) to enter the Indian market.

Understanding the Wound Auto Fluorescence Imaging Device and Its Regulatory Importance

A wound auto fluorescence imaging device is designed to visualize auto fluorescence images from skin wounds exposed to excitation light. Importantly, it is not intended to provide quantitative or diagnostic information, which influences its classification as Class B under the CDSCO framework. Compliance with CDSCO regulations ensures patient safety, product quality, and market access in India.

CDSCO Regulatory Framework for Wound Auto Fluorescence Imaging Devices

Under the Medical Device Rules, 2017, wound auto fluorescence imaging devices fall under Class B devices due to their moderate risk profile. The regulatory authority for Class B devices is the State Licensing Authority, which issues the MD5 manufacturing license.

Manufacturers must follow a structured process including obtaining a test license, product testing at government-approved labs, document compilation, audit by notified bodies, and final license approval.

Risk Classification and License Requirements for Class B Devices

Class B devices like the wound auto fluorescence imaging device require obtaining the MD5 license under Form MD3. The process involves:

  • Test license (Form MD13) application and approval
  • Product testing in CDSCO-approved laboratories
  • Submission of manufacturing license application
  • Audit by a notified body
  • Resolution of queries
  • Grant of the MD5 license (Form MD5)

This classification mandates adherence to specific documentation and regulatory compliances to ensure safety and efficacy.

Step-by-Step Manufacturing License Process (MD5) for Wound Auto Fluorescence Imaging Device

  1. Apply for Test License (MD13): Initiate with Form MD13 via the CDSCO MD Online Portal. The test license is mandatory before manufacturing or testing the device.
  2. Product Testing: Conduct product testing at government-approved labs listed on the CDSCO Testing Laboratories page. Testing duration typically ranges from 4 to 6 weeks.
  3. Document Preparation: Compile all necessary technical and quality documents including Device Master File, Plant Master File, Essential Principles Checklist, and Risk Management File.
  4. Application Submission: File the MD5 license application (Form MD3) through the CDSCO portal.
  5. Audit by Notified Body: Engage a notified body for a mandatory audit. Refer to the list of notified bodies to select an authorized auditor.
  6. Query Resolution: Address any queries or deficiencies raised by the notified body or CDSCO.
  7. Grant of MD5 License: Upon satisfactory compliance, the State Licensing Authority grants the manufacturing license.

Essential Documents Required for MD5 License Application

For a Class B wound auto fluorescence imaging device, the following documents are critical:

  • Company Constitution and Incorporation Certificate
  • Proof of Ownership or Lease Agreement of Manufacturing Premises
  • Technical Staff Qualification and Experience Proofs
  • Fire NOC and Pollution Control Board NOC
  • Device Master File detailing design and specifications (Device Master File Guide)
  • Plant Master File covering manufacturing facility details (Plant Master File Guide)
  • Essential Principles Compliance Checklist
  • Risk Management File demonstrating risk assessments (Risk Management)
  • Product Test Reports from CDSCO-approved labs
  • Product Labels and Instructions for Use (IFU)
  • Quality Management System (QMS) Documents such as ISO 13485 certification or equivalent

Ensuring these documents are complete and accurate substantially reduces the risk of delays.

Import License Process (MD15) for Wound Auto Fluorescence Imaging Devices

For importers looking to bring wound auto fluorescence imaging devices into India, the MD15 import license must be obtained from the Central Licensing Authority. The application is filed on Form MD14 via the CDSCO MD Online Portal.

Import license requires submission of documents including:

  • Valid Manufacturing License from the country of origin
  • Free Sale Certificate
  • ISO 13485:2016 Certification
  • CE Certificate or equivalent
  • Device Master File and Plant Master File
  • Wholesale License (if applicable)
  • Company Constitution

The MD15 license process takes approximately 5-6 months, with government fees based on device class and number of products.

For detailed import licensing guidance, refer to our Import License Guide.

Timeline and Processing Duration for MD5 License

  • Test License (MD13): 1.5 to 2 months
  • Product Testing: 4 to 6 weeks
  • Document Preparation: Concurrent with testing
  • Application Submission to License Grant: 1.5 to 2 months

Total Duration: Approximately 3 to 4 months from test license application to MD5 license grant.

Government Fees and Costs

  • Test License (MD13): Included within overall fees
  • MD5 License Application Fee: Rs. 5,000 per application
  • Product Fee: Rs. 500 per product
  • Notified Body Audit and Testing Costs: Variable, typically Rs. 50,000 to Rs. 1,00,000 depending on device complexity and notified body

Budgeting for these fees upfront helps avoid unexpected financial bottlenecks.

Common Challenges and Solutions in MD5 Licensing

  • Incomplete Documentation: Ensure all technical files and compliance documents are prepared meticulously. Use our Device Master File guide and Plant Master File guide for structured document preparation.
  • Delayed Product Testing: Plan testing schedules early and select government-approved labs with proven turnaround times.
  • Audit Non-Compliance: Conduct pre-audit internal inspections and QMS assessments to align with notified body expectations.
  • Query Resolution Delays: Promptly address CDSCO and notified body queries with clear, documented responses.

Expert Consultation and Support for Your Device Licensing

Navigating the MD5 licensing pathway for Class B devices like the wound auto fluorescence imaging device can be complex. Our consultancy has successfully supported over 500 manufacturers and importers by providing:

  • Comprehensive dossier preparation
  • Liaison with notified bodies and CDSCO authorities
  • Strategic planning for timelines and regulatory milestones
  • End-to-end application filing and post-submission support

Engaging experienced consultants reduces time-to-market and ensures regulatory compliance.

Getting Started with Your CDSCO License Application for Wound Auto Fluorescence Imaging Device

  1. Assess your device classification and intended use carefully. Confirm Class B designation as per CDSCO device classification.
  2. Register and submit the test license application (Form MD13) via the CDSCO MD Online Portal.
  3. Schedule product testing with a CDSCO-approved testing laboratory.
  4. Begin compiling your Device Master File, Plant Master File, and Risk Management File. Leverage our guides for efficient document creation.
  5. Engage a notified body early to prepare for the audit stage.
  6. Upon successful testing and document readiness, submit your MD5 license application (Form MD3) online.
  7. Prepare for and facilitate the audit, respond promptly to queries, and track your application status through the CDSCO portal.

By following these actionable steps and leveraging expert support, manufacturers of wound auto fluorescence imaging devices can confidently navigate the CDSCO licensing process and access the Indian medical device market smoothly.

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About the Author

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Tails Azimuth
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