CDSCO License for Flexible ureteral sheath/fibreoptic telescope

Introduction to Flexible Ureteral Sheath/Fibreoptic Telescope and Regulatory Importance

Flexible ureteral sheaths and fibreoptic telescopes are specialized sterile medical devices designed for flexible endoscopic procedures within the urinary tract. These devices enable urologists to visually examine and treat body cavities accessible via the ureter, supporting cystoscopic, nephroscopic, laparoscopic, and ureteroscopic interventions. Given their critical role in patient care and invasive nature, regulatory compliance is essential to ensure safety, efficacy, and quality.

At our consultancy, with over 25 years of experience and having assisted 500+ companies, we understand the nuances of obtaining CDSCO approval for devices like the Flexible Ureteral Sheath/Fibreoptic Telescope classified as Class B under Indian regulations. This comprehensive guide will walk you through the CDSCO framework, licensing processes, timelines, costs, and practical tips to secure your license efficiently.

CDSCO Regulatory Framework for Flexible Ureteral Sheath/Fibreoptic Telescope

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India. Since the device falls under the urology category and is notified under File No. 29/Misc./03/2020-DC (145) dated 23.08.2021, it must comply with CDSCO’s specific requirements for Class B devices.

This classification subjects the device to a state-level manufacturing license (MD5) or import license (MD15) if applicable. The regulatory framework emphasizes conformity with essential principles, risk management, and quality management systems such as ISO 13485:2016.

Risk Classification and License Requirements for Class B Devices

As a Class B (low-moderate risk) device, the Flexible Ureteral Sheath/Fibreoptic Telescope requires the MD5 manufacturing license for local production and MD15 for importation.

• MD5 License: Issued by the State Licensing Authority.
• MD15 License: Issued by the Central Licensing Authority for imports.

The MD5 license process involves obtaining a test license (MD13) first, followed by product testing, document submission, and an audit by a notified body. The process generally takes 3-4 months.

For detailed classification, refer to our Medical Device Classification guide.

Manufacturing License Process (MD5) for Flexible Ureteral Sheath/Fibreoptic Telescope

1. Test License Application (Form MD13): Apply through the CDSCO MD Online Portal for a test license. This license allows product testing and takes approximately 1.5 to 2 months to obtain.

2. Product Testing: After receiving the test license, product samples must be tested at CDSCO-approved laboratories. For your device, ensure testing for sterility, biocompatibility, mechanical integrity, and optical performance. Find approved labs in the Testing Laboratories list.

3. Document Preparation: Compile comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, test reports, labels, and Instructions for Use (IFU).

4. Application Submission (Form MD3): Submit the manufacturing license application through the CDSCO portal.

5. Audit by Notified Body: A CDSCO-recognized notified body will audit your manufacturing facility. Check the Notified Bodies List to identify authorized auditors.

6. Query Resolution: Address any queries raised by the CDSCO or the notified body promptly.

7. License Grant: Upon successful audit and document approval, the MD5 license on Form MD5 is granted.

For an in-depth procedural overview, our MD5 License Guide offers step-by-step assistance.

Manufacturing License Documents Required

For the Flexible Ureteral Sheath/Fibreoptic Telescope, the following documents must be meticulously prepared:

• Company constitution and registration proof
• Proof of ownership or lease of manufacturing premises
• Qualification and experience certificates of technical staff
• Fire and pollution NOCs
• Device Master File (DMF) detailing product specifications and design
• Plant Master File (PMF) outlining manufacturing processes and quality control
• Essential Principles Checklist confirming compliance with CDSCO guidelines
• Risk Management File demonstrating hazard analysis and mitigation strategies
• Product test reports from CDSCO-approved labs
• Product labels and Instructions for Use (IFU) compliant with Indian regulations
• Quality Management System (QMS) documents, preferably ISO 13485:2016 certified

For guidance on preparing DMF and PMF, consult our Device Master File Guide and Plant Master File Guide.

Import License Process (MD15) for Flexible Ureteral Sheath/Fibreoptic Telescope

If you are importing the device into India, the MD15 license from the Central Licensing Authority is mandatory.

1. Document Preparation: Assemble all required documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), DMF, PMF, wholesale license, and company constitution.

2. Application Submission (Form MD14): File the import license application on the CDSCO MD Online Portal.

3. Query Resolution: Respond to departmental queries promptly to avoid delays.

4. License Grant: After thorough review, the MD15 license is issued.

Refer to our detailed Import License Guide for comprehensive instructions.

Import License Documents Required

Key documents for MD15 include:

• Manufacturing License from the exporting country
• Free Sale Certificate or Certificate of Export
• ISO 13485:2016 certificate
• CE Certificate if marketed in Europe
• Device Master File and Plant Master File
• Wholesale Drug License valid in India
• Company constitution and registration proof

Ensuring these documents are accurate and up-to-date accelerates the approval process.

Timeline and Processing Duration

Proactive preparation of documents and rapid response to queries can significantly reduce these timelines.

Government Fees and Costs

For Class B devices like the Flexible Ureteral Sheath/Fibreoptic Telescope, the fees are as follows:

• MD5 Manufacturing License: Rs 5,000 per application + Rs 500 per product
• Test License (MD13): Included in overall process, no separate fee

For import:

• MD15 Import License:
  • Class B: $2000 per site +$1000 per product

All applications are submitted and fees paid through the CDSCO MD Online Portal.

Common Challenges and Solutions

Challenge: Delays due to incomplete documentation.

Solution: Utilize detailed checklists and expert review to ensure all documents meet CDSCO requirements before submission.

Challenge: Audit non-conformities leading to extended timelines.

Solution: Pre-audit assessments and gap analysis with a notified body can prepare your facility for successful audits.

Challenge: Prolonged testing due to lack of knowledge about testing parameters.

Solution: Engage with CDSCO-approved testing labs early to understand precise test protocols for flexible ureteral sheaths.

Challenge: Confusion over risk classification and corresponding license forms.

Solution: Refer to authoritative classification resources and consult experienced regulatory professionals.

Expert Consultation and Support

With over 25 years of regulatory expertise and over 500 successful CDSCO license applications, our team offers:

• Tailored regulatory strategy for your device
• Complete documentation preparation and review
• Coordination with notified bodies and testing labs
• Application submission and tracking via CDSCO MD Online Portal
• Post-approval compliance and renewal assistance

Our practical, hands-on approach ensures smoother, faster approvals and peace of mind.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm Class B status via official CDSCO resources.

2. Prepare Quality and Risk Management Files: Begin compiling DMF, PMF, and Risk Management File using our guides.

3. Apply for Test License: Submit Form MD13 on the CDSCO MD Online Portal to start product testing.

4. Engage Testing Laboratories: Coordinate with government-approved labs for sterility and performance testing.

5. Plan for Audit: Identify a notified body for your state and schedule a pre-audit consultation.

6. Compile Application: Assemble all documentation and submit Form MD3 for MD5 manufacturing license.

7. Monitor and Respond: Actively track application status and respond to queries swiftly.

Starting early and following these steps methodically will position your Flexible Ureteral Sheath/Fibreoptic Telescope for timely market entry in India.

For personalized assistance, connect with our regulatory experts to navigate your CDSCO licensing journey efficiently.