CDSCO License for Fibreoptic ureteral catheter, reusable
Medical Device Information
Intended Use
A flexible tube containing a fibreoptic bundle that emits light throughout its length, intended to be inserted into the ureter for illumination to enable the path of the ureter to be seen. It also includes a plug for connection to a fibreoptic light source and a port for irrigation at its proximal end.
Comprehensive Guide to CDSCO Licensing for Fibreoptic Ureteral Catheters (Reusable)
As a medical device regulatory consultancy with over 25 years of experience and having successfully supported 500+ companies, we understand the intricacies involved in obtaining CDSCO licenses in India. This guide focuses on the Fibreoptic Ureteral Catheter, reusable—a Class B medical device used in urology for ureter illumination—detailing the regulatory framework, licensing requirements, timelines, and practical tips for manufacturers and importers.
Understanding the Fibreoptic Ureteral Catheter and Its Regulatory Importance
The reusable fibreoptic ureteral catheter is a highly specialized device designed to provide illumination within the ureter during urological procedures. Its fibreoptic bundle emits light throughout its length, facilitating clear visualization of the ureter path. This device’s reusable nature necessitates strict compliance with regulatory standards to ensure patient safety, especially given its direct contact with sensitive internal tissues.
Given its classification as a Class B device under the CDSCO risk framework, this catheter requires a manufacturing license MD5 issued by the State Licensing Authority. Compliance with these regulations is mandatory before marketing or manufacturing within India.
CDSCO Regulatory Framework for Fibreoptic Ureteral Catheters (Reusable)
The Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices in India under the Medical Device Rules, 2017. For reusable fibreoptic ureteral catheters, the key regulatory steps involve:
- Risk classification confirmation as Class B (moderate risk)
- Obtaining a Test License (Form MD-13) for product testing
- Product testing from CDSCO-approved laboratories
- Submission of a manufacturing license application (Form MD-3 for MD5 license)
- Audit by a notified body
- Final grant of manufacturing license (Form MD-5)
Risk Classification and License Requirements for Class B Devices
The fibreoptic ureteral catheter falls under Class B due to its moderate risk profile linked to internal use and reusability. This classification mandates the following licensing pathway:
| License Type | Form Used | Licensing Authority | Timeline | Government Fees (INR) |
|---|---|---|---|---|
| Manufacturing MD5 | MD-3 | State Licensing Authority | 3 to 4 months total | Rs. 5,000 per application + Rs. 500/product |
For detailed classification criteria, manufacturers can refer to the Medical Device Classification guide.
Manufacturing License Process for Fibreoptic Ureteral Catheter (MD5 License)
The MD5 license process for Class B devices like the fibreoptic ureteral catheter involves several sequential steps that must be meticulously followed:
Obtain a Test License (Form MD-13): This initial step permits sample testing and typically takes 1.5 to 2 months. The test license allows submission of product samples to CDSCO-approved testing laboratories.
Product Testing: Samples must be tested at government-approved labs to verify compliance with applicable standards. Refer to the CDSCO Testing Laboratories list for authorized facilities.
Document Preparation: Prepare a comprehensive dossier including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, test reports, and device labeling.
Application Submission (Form MD-3): Submit your manufacturing license application via the CDSCO MD Online Portal with all required documents.
Audit by Notified Body: The manufacturing site will be audited by a notified body certified for Class B audits. Check the list of notified bodies to select an appropriate auditor.
Resolution of Queries: Address any queries raised by the CDSCO or the notified body promptly to avoid delays.
Grant of Manufacturing License (Form MD-5): Upon satisfactory completion of the audit and document review, the state licensing authority issues the MD5 license.
Manufacturing License Documents Required for Fibreoptic Ureteral Catheter
To ensure a smooth licensing process, the following documents must be meticulously prepared and submitted:
- Company Constitution Documents (e.g., incorporation certificate, partnership deed)
- Proof of Premises Ownership or Lease
- Technical Staff Qualification and Experience Certificates
- Fire and Pollution NOCs
- Device Master File (DMF) detailing design, specifications, and manufacturing processes (Device Master File Guide)
- Plant Master File (PMF) describing the manufacturing facility and quality control systems (Plant Master File Guide)
- Essential Principles Checklist ensuring compliance with regulatory safety and performance requirements
- Risk Management File demonstrating identification and mitigation of risks (Risk Management)
- Test Reports from CDSCO-approved labs
- Device Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents aligned with ISO 13485 standards
Import License Process for Fibreoptic Ureteral Catheter (MD15 License)
Manufacturers or importers intending to bring this Class B device into India must secure an Import License (MD15) from the Central Licensing Authority. The process includes:
- Preparation of import dossier including Manufacturing License, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate if applicable, Device and Plant Master Files.
- Submission of application on the CDSCO MD Online Portal.
- Resolution of any departmental queries.
- Final grant of Import License (Form MD-15).
For detailed guidance, consult our comprehensive Import License Guide.
Import License Documents Required for Fibreoptic Ureteral Catheter
- Valid manufacturing license from the country of origin
- Free Sale Certificate from the country of origin
- ISO 13485:2016 Quality Management System certificate
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale Drug License (if applicable)
- Company Constitution documents
- Application Form MD-14
Timeline and Processing Duration
| Process Step | Approximate Duration |
|---|---|
| Test License (MD-13) | 1.5 to 2 months |
| Product Testing | 1 to 1.5 months |
| Documentation Preparation | Concurrent with testing |
| Manufacturing License (MD5) | 3 to 4 months (total) |
| Import License (MD15) | 5 to 6 months |
Government Fees and Costs
For the manufacturing license (MD5) of a Class B device such as the fibreoptic ureteral catheter:
- Application Fee: Rs. 5,000 per application
- Product Fee: Rs. 500 per product
Testing and audit costs vary depending on the notified body and testing laboratory fees. Budget an additional Rs. 50,000 to Rs. 1,00,000 for comprehensive testing and audit services.
Common Challenges and Practical Solutions
Delayed Test Reports: Testing can take longer than expected. Engage with approved labs early and submit complete samples to avoid rejections.
Incomplete Documentation: Ensure all files, especially Device Master File and Risk Management File, are detailed and compliant to avoid audit non-conformities.
Audit Non-Compliance: Pre-audit mock inspections can help identify gaps in manufacturing and QMS.
Query Resolution Delays: Respond promptly and comprehensively to CDSCO queries; engage regulatory experts if needed.
Expert Consultation and Support
Navigating CDSCO licensing for a reusable fibreoptic ureteral catheter can be complex. Our team offers hands-on support from initial classification to license grant:
- Preparation of Device and Plant Master Files
- Coordination with notified bodies and testing labs
- Comprehensive document audit and gap analysis
- Strategic query management with CDSCO authorities
Our proven track record with over 500 successful CDSCO licenses means we can help you avoid common pitfalls and accelerate market entry.
Getting Started with Your CDSCO License Application
Confirm Device Classification: Verify Class B status using the CDSCO classification tool.
Register on CDSCO MD Online Portal: Create your company profile and prepare for application submission.
Apply for Test License (Form MD-13): Initiate product testing by applying for the test license.
Prepare Documentation: Simultaneously prepare your Device and Plant Master Files, risk management, and QMS documents.
Engage Notified Body: Schedule and prepare for the manufacturing site audit.
Submit Manufacturing License Application (Form MD-3): Once test reports and audits are complete, file the license application.
For detailed guidance and personalized support, contact our regulatory consultants who specialize in medical devices like the fibreoptic ureteral catheter. Leverage our expertise to ensure a smooth, timely, and compliant CDSCO licensing process.
Embark on your regulatory journey today by submitting your application through the CDSCO MD Online Portal. Our expert team is ready to assist you at every step.
