CDSCO License for Flexible video ureteroscope, reusable

Comprehensive Guide to CDSCO Licensing for Flexible Video Ureteroscope (Reusable) – Class B Medical Device

As seasoned regulatory consultants with over 25 years of experience and having successfully assisted 500+ companies, we understand the nuances of securing CDSCO licenses for specialized devices like the flexible video ureteroscope (reusable). This Class B urology device plays a crucial role in minimally invasive urinary tract procedures, offering visual examination and treatment capabilities for the ureter. Given its critical clinical application, navigating the CDSCO regulatory framework accurately is essential for timely market entry in India.

CDSCO Regulatory Framework for Flexible Video Ureteroscope

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India. Since the 2020 notification (File No. 29/Misc./03/2020-DC (145), dated 23.8.2021), flexible video ureteroscopes fall under Class B risk classification due to their invasive yet low-risk nature.

This classification mandates compliance with the Medical Device Rules, 2017, including obtaining a manufacturing license (MD5) from the State Licensing Authority before production and marketing.

Risk Classification and License Requirements

• Device: Flexible Video Ureteroscope (Reusable)
• Risk Class: B (Low to moderate risk)
• Regulatory License: MD5 Manufacturing License
• Authority: State Licensing Authority
• Application Form: MD3 for manufacturing license

For Class B devices, the MD5 license process includes a mandatory test license (MD13), product testing by government-approved laboratories, documentation, audits by notified bodies, and regulatory review.

Manufacturing License Process (MD5) for Class B Devices

1. Obtain Test License (MD13):

   • Submit application through the CDSCO MD Online Portal
   • Processing time: Approximately 1.5 to 2 months

2. Product Testing:

   • Conduct product testing at CDSCO-approved labs such as those listed here: Testing Laboratories
   • Testing includes performance, electrical safety, biocompatibility, and sterilization validation specific to reusable endoscopic devices.

3. Prepare Documentation:

   • Compile comprehensive technical files including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist

4. Apply for MD5 License (Form MD3):

   • Submit complete application via the MD Online portal

5. Audit by Notified Body:

   • Coordinate audit with a notified body from the official list: Notified Bodies List
   • Audit covers quality management system compliance (ISO 13485), manufacturing practices, and technical documentation.

6. Resolve Queries:

   • Address any observations raised by CDSCO or notified body promptly

7. Grant of License:

   • Upon satisfactory review and audit, license is granted on Form MD5

Manufacturing License Documents Required

A successful MD5 application for the flexible video ureteroscope requires the following documentation:

• Company Constitution Documents (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of Ownership or Lease of Manufacturing Premises
• Qualification and Experience Documents of Technical Staff
• Valid Fire NOC and Pollution Control NOC
• Device Master File (DMF): Detailed design, specifications, and manufacturing processes (Device Master File Guide)
• Plant Master File (PMF): Description of manufacturing facilities and quality control (Plant Master File Guide)
• Essential Principles Compliance Checklist
• Risk Management File demonstrating hazard identification and mitigation (Risk Management Guide)
• Test Reports from approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documentation, typically ISO 13485:2016 certification

Import License Process (MD15) for Flexible Video Ureteroscope

If importing the flexible video ureteroscope instead of manufacturing in India, an MD15 import license from the Central Licensing Authority is required.

• Application Form: MD14
• Timeline: Approximately 5-6 months
• Documents Required:
  • Valid Manufacturing License from country of origin
  • Free Sale Certificate
  • ISO 13485:2016 and CE Certificates
  • Device Master File and Plant Master File
  • Wholesale License
  • Company Constitution Documents

The import license process does not require a test license but mandates thorough documentation and regulatory scrutiny.

Timeline and Processing Duration for MD5 License

Total Estimated Time: Approximately 3 to 4 months

Government Fees and Costs

• Application Fee: ₹5,000 per application
• Product Fee: ₹500 per product (device variation or accessories)
• Audit and Testing Costs: Variable depending on notified body and laboratory fees (typically ₹50,000 – ₹100,000)

Budgeting realistically for audit, testing, and consultancy support is crucial to avoid delays.

Common Challenges and Solutions

• Incomplete Documentation: Ensure all technical files are thorough and comply with CDSCO templates.
• Delays in Testing: Plan testing slots early with government-approved labs to avoid bottlenecks.
• Audit Readiness: Maintain a robust ISO 13485 QMS and document control to pass audits smoothly.
• Regulatory Queries: Prepare prompt, clear responses to CDSCO and notified body questions to expedite approval.

Expert Consultation and Support

Navigating the CDSCO licensing process for a Class B device like the flexible video ureteroscope requires precision and regulatory insight. Our consultants bring hands-on experience with over 500 successful approvals, guiding manufacturers from documentation setup to audit completion.

We offer tailored support including:

• Gap analysis of technical files
• Assistance in test license and manufacturing license applications
• Coordination with notified bodies and testing labs

Getting Started with Your CDSCO License Application

1. Register on the CDSCO MD Online Portal to initiate your application.
2. Prepare and submit the test license application (MD13) to kick-start product testing.
3. Engage an accredited testing laboratory early to schedule tests – this avoids critical path delays.
4. Gather all mandatory documentation with emphasis on Device Master File, Plant Master File, and Risk Management files.
5. Plan your notified body audit after test reports are finalized.

By following these steps and leveraging expert regulatory support, manufacturers of flexible video ureteroscopes can confidently secure their CDSCO MD5 license and successfully enter the Indian market.

For a personalized consultation or assistance with your CDSCO application, reach out to our experienced team today.