CDSCO License for Ureteral patency kit

Comprehensive Guide to CDSCO Licensing for Ureteral Patency Kit (Class B Medical Device)

Navigating the regulatory landscape to market a Ureteral Patency Kit in India requires a thorough understanding of the CDSCO framework. As a trusted regulatory consultancy with over 25 years of experience supporting 500+ manufacturers and importers, we provide you with an expert roadmap tailored specifically for your Class B urology device designed to assist in treating blocked ureters and maintaining ureteral patency.

Understanding Your Device: Ureteral Patency Kit Overview and Regulatory Importance

The Ureteral Patency Kit is a specialized collection of devices used to ensure ureteral openness through natural or percutaneous access. Falling under the urology category and classified as a Class B medical device by CDSCO, it carries a moderate risk profile requiring a state-level manufacturing license (MD5). Compliance with CDSCO regulations is mandatory before manufacturing or importing this device into India, ensuring patient safety, product quality, and legal market access.

CDSCO Regulatory Framework for Ureteral Patency Kit

The Central Drugs Standard Control Organisation (CDSCO) regulates medical devices in India. Your Ureteral Patency Kit is covered under the notification File No. 29/Misc./03/2020-DC (145) dated 23.08.2021, confirming its inclusion in the regulatory purview. Being a Class B device, regulatory oversight includes:

• Mandatory factory audit by a notified body
• Product testing from CDSCO-approved laboratories
• Submission of a comprehensive dossier including technical and quality management documentation

Manufacturing licenses for Class B devices are granted by the State Licensing Authority through the MD5 license process.

Risk Classification and License Requirements for Class B Devices

Class B medical devices are considered low to moderate risk. The CDSCO mandates the MD5 manufacturing license for domestic production. If you intend to import Ureteral Patency Kits, the MD15 import license issued by the Central Licensing Authority is required.

For manufacturing, the process involves obtaining a test license first (MD13), product testing, documentation, audit, and final license issuance.

Step-by-Step Manufacturing License Process (MD5) for Ureteral Patency Kit

1. Apply for Test License (Form MD13):
   • Timeline: 1.5 to 2 months
   • Purpose: Allows manufacturing of samples for testing
2. Product Testing:
   • Conducted at CDSCO-approved laboratories
   • Typical duration: 4-6 weeks
   • Refer to the list of testing laboratories for authorized centers
3. Prepare Documentation:
   • Device Master File (DMF)
   • Plant Master File (PMF)
   • Essential Principles Checklist
   • Risk Management File
   • Quality Management System (QMS) documents
   • Test reports, labels, and Instructions for Use (IFU)
4. Submit MD5 License Application (Form MD3) on the CDSCO MD Online Portal:
   • Upload all required documents
   • Pay applicable fees
5. Audit by Notified Body:
   • Audit scheduling and execution
   • Refer to the list of notified bodies for authorized auditors
6. Resolve Queries:
   • Address any questions raised by CDSCO or notified body promptly
7. Grant of MD5 License:
   • Issued on Form MD5

Essential Documents Required for MD5 License Application

• Company Constitution and Incorporation Certificates
• Proof of Premises Ownership or Lease Agreement
• Technical Staff Qualifications and Experience
• Fire and Pollution NOCs
• Device Master File (comprehensive device specifications and manufacturing process) – see our detailed Device Master File guide
• Plant Master File (facility and quality system details) – detailed in our Plant Master File guide
• Essential Principles Checklist confirming compliance with Indian standards
• Risk Management File demonstrating hazard analysis and mitigation
• Product Test Reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System Documentation (ISO 13485 compliance preferred)

Import License Process (MD15) for Ureteral Patency Kit

If your company plans to import the Ureteral Patency Kit into India, the MD15 import license issued by the CDSCO Central Licensing Authority is mandatory. The process involves:

• Document preparation (including existing manufacturing license, Free Sale Certificate, ISO 13485:2016 certificate, CE Certificate)
• Submission of application via Form MD14 on the CDSCO MD Online Portal
• Response to departmental queries
• License issuance on Form MD15

The entire process generally takes 5 to 6 months.

Documents Required for Import License (MD15)

• 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 and Incorporation Documents

Timeline and Processing Duration for Ureteral Patency Kit Licensing

Government Fees and Costs Breakdown

• MD5 License:
  • Application Fee: Rs. 5,000 per application
  • Product Fee: Rs. 500 per product
• Test License (MD13):
  • Fees as per CDSCO norms (usually nominal)
• Import License (MD15):
  • Class B Device Fees: Approximately $2,000 per site and$1,000 per product

Additional costs to consider include notified body audit fees and product testing charges. We recommend budgeting ₹1-2 lakhs for comprehensive testing and audit combined.

Common Challenges in CDSCO Licensing and Practical Solutions

• Delayed Test License Approval:
  • Ensure complete and accurate Form MD13 submission
  • Engage with CDSCO officials proactively
• Testing Laboratory Backlogs:
  • Choose government-approved labs with shorter turnaround
  • Plan testing timelines well in advance
• Audit Non-Compliance:
  • Conduct internal mock audits
  • Maintain up-to-date QMS and documentation
• Query Resolution Delays:
  • Prepare detailed responses
  • Maintain regular communication with CDSCO officers

Expert Consultation and Support

Our extensive experience with 500+ successful CDSCO license applications positions us uniquely to help you navigate complex requirements for your Ureteral Patency Kit. We assist with:

• Comprehensive gap analysis and documentation preparation
• Liaising with notified bodies and CDSCO authorities
• Scheduling and preparing for audits
• Strategic timeline management to accelerate approvals

Getting Started with Your CDSCO License Application

1. Classify Your Device Accurately: Confirm your device is Class B using CDSCO classification tools (Medical Device Classification).
2. Register on CDSCO MD Online Portal: Create your account to submit applications and track status.
3. Apply for Test License (MD13): Begin with the test license to legally manufacture samples.
4. Engage a Government-Approved Testing Laboratory: Arrange sample testing early.
5. Prepare Your Device and Plant Master Files: Use our expert guides for accurate document creation.
6. Schedule and Prepare for Audit: Select a notified body and ensure compliance readiness.

By following this tailored roadmap, you can confidently navigate the regulatory process for your Ureteral Patency Kit, ensuring timely market entry and regulatory compliance in India. For personalized assistance, reach out to our expert team today.

References and Resources:

• Submit your application through the CDSCO MD Online Portal
• Check the list of notified bodies authorized for audits
• Find authorized Testing Laboratories
• Explore our Device Master File guide
• Learn how to Easily Create Plant Master Files
• Understand detailed Medical Device Classification