CDSCO License for Urethral Catheter/Nelaton Catheter/ Foley Catheter
Medical Device Information
Intended Use
A long, small gauge catheter designed f or insertion directly into a ureter, either through the urethra andbladder or post eriorly via the kidney.
Comprehensive Guide to CDSCO Licensing for Urethral Catheters (Class B Medical Devices)
Manufacturers and importers of Urethral Catheters (including Nelaton and Foley Catheters), classified as Class B medical devices under Indian regulations, must navigate a detailed regulatory framework to lawfully market these devices in India. These catheters are designed for insertion directly into a ureter, either through the urethra and bladder or posteriorly via the kidney, playing a critical role in urological care. Given their invasive nature and patient safety implications, obtaining the correct CDSCO license is essential.
With over 25 years of experience assisting more than 500 companies in securing regulatory approvals, we provide an expert, step-by-step breakdown of the licensing process, timelines, fees, and common challenges for Urethral Catheters under CDSCO jurisdiction.
CDSCO Regulatory Framework for Urethral Catheters
The Central Drugs Standard Control Organization (CDSCO) governs medical device registration and licensing in India. Since the notification dated 06.06.2018 (29/Misc/3/2017-DC (292)), Urethral Catheters have been regulated under the Catheters category, classified as Class B devices.
Class B devices are considered low to moderate risk and require a Manufacturing License (MD5 license) issued by the State Licensing Authority. For imports, an MD15 import license from the Central Licensing Authority is mandatory.
You must comply with the Medical Devices Rules, 2017, and submit all documentation through the official CDSCO MD Online Portal.
Risk Classification and License Requirements for Urethral Catheters
| Risk Class | License Type | Licensing Authority | Typical Timeline | Fees (Approx) |
|---|---|---|---|---|
| Class B | MD5 (Manufacturing) | State Licensing Authority | 3-4 months | Rs 5,000 + Rs 500 per product |
| Import | MD15 (Import License) | Central Licensing Authority | 5-6 months | Rs 3000 per site + Rs 1500 per product |
The MD5 license is required for manufacturing these catheters in India. This involves multiple steps, including a mandatory test license (MD13), product testing from CDSCO-approved labs, documentation, and audits by notified bodies.
For importers, the MD15 import license is compulsory, which requires a different set of documents and approvals.
Manufacturing License Process for Class B Urethral Catheters (MD5 License)
The manufacturing license process involves the following key stages:
Test License (Form MD13): Apply for a test license to enable initial manufacturing for testing purposes. This takes approximately 1.5-2 months.
Product Testing: Get your urethral catheters tested at government-approved laboratories. Refer to the list of Testing Laboratories for accredited centers.
Documentation Preparation: Prepare detailed technical files including Device Master File (DMF), Plant Master File (PMF), Risk Management File, Essential Principles Checklist, and Quality Management System documents.
Application Submission: Submit the manufacturing license application using Form MD3 via the CDSCO MD Online Portal.
Audit by Notified Body: Schedule and complete an audit by a notified body accredited for Class B devices. Check the Notified Bodies List to select a suitable auditor.
Query Resolution: Address any queries raised by the CDSCO or notified body promptly.
License Grant: Upon satisfactory compliance, the MD5 license is granted.
For a detailed walkthrough, our MD5 License Guide provides invaluable insights.
Manufacturing License Documents Required
The documentation for MD5 license for urethral catheters includes:
- Company Constitution (Incorporation Certificate, MOA/AOA)
- Proof of ownership or lease agreement of manufacturing premises
- Technical staff credentials and qualification documents
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) detailing design, manufacturing process, and specifications (Device Master File Guide)
- Plant Master File (PMF) describing manufacturing facilities and quality controls (Plant Master File Guide)
- Essential Principles Checklist ensuring compliance with safety and performance standards
- Risk Management File documenting hazard analysis and mitigation (Risk Management Guide)
- Test Reports from government-approved labs
- Product labels and Instructions for Use (IFU)
- Quality Management System documentation (e.g., ISO 13485:2016 certification)
Accurate and complete documentation significantly reduces processing time and query frequency.
Import License Process (MD15 License) for Urethral Catheters
For importers of urethral catheters, the MD15 import license process includes:
Document Preparation: Compile necessary documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate, Device Master File, Plant Master File, wholesale license, and company constitution.
Application Submission: File the application on the CDSCO portal using Form MD14.
Query Resolution: Address any queries raised by the CDSCO.
License Grant: Upon satisfactory evaluation, the import license (MD15) is issued.
This process typically takes 5-6 months due to the centralized review and multiple document verifications. See our Import License Guide for detailed assistance.
Import License Documents Required
The MD15 import license requires:
- Valid manufacturing license from the exporting country
- Free Sale Certificate
- ISO 13485:2016 certification
- CE Certificate or equivalent international approval
- Device Master File and Plant Master File
- Wholesale License
- Company Constitution
Ensuring authenticity and proper notarization of foreign documents expedites approval.
Timeline and Processing Duration
| License Type | Step | Duration |
|---|---|---|
| MD5 License | Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 month (varies) | |
| Documentation & Application | 2 weeks | |
| Audit by Notified Body | 3-4 weeks | |
| Query Resolution & Grant | 2-3 weeks | |
| Total | 3-4 months |
| MD15 License | Document Preparation | 1 month | | | Application & Review | 3-4 months | | | Query Resolution & Grant | 1 month | | Total | | 5-6 months |
Timely responses to queries and preemptive document readiness are key to avoiding delays.
Government Fees and Costs
| License Type | Application Fee (INR) | Per Product Fee (INR) | Notes |
|---|---|---|---|
| MD5 | 5,000 | 500 | Applies to manufacturing license |
| MD15 | 3,000 (Class B site) | 1,000 | Import license fees |
Additional costs include notified body audit fees (varies by auditor), testing lab charges (approx Rs 50,000-1,00,000 depending on tests), and consultancy fees if engaged.
Common Challenges and Solutions
Challenge 1: Delays in Product Testing
- Solution: Engage with CDSCO-approved labs early and schedule testing slots in advance.
Challenge 2: Incomplete Documentation
- Solution: Use comprehensive checklists and expert consultations to ensure all documents, especially DMF and PMF, are correctly prepared.
Challenge 3: Audit Non-Compliance
- Solution: Conduct internal audits and mock inspections to prepare technical staff and facilities before notified body audits.
Challenge 4: Query Backlogs and Response Delays
- Solution: Assign dedicated regulatory personnel for prompt query resolution and maintain clear communication with CDSCO.
Expert Consultation and Support
Navigating the CDSCO licensing process for urethral catheters can be complex, especially for first-time manufacturers and importers. With our 25+ years of experience and 500+ successful approvals, we offer tailored consultancy services including:
- Gap analysis of your current compliance status
- Detailed document preparation support
- Coordination with notified bodies and testing labs
- End-to-end application management via the CDSCO MD Online Portal
Our proactive approach minimizes risk of rejection and accelerates market entry.
Getting Started with Your CDSCO License Application for Urethral Catheters
Assess Your Product Classification: Confirm your catheter falls under Class B using the Medical Device Classification resource.
Engage Testing Labs: Immediately contact CDSCO-approved testing laboratories to initiate product testing.
Prepare Documentation: Collect and compile all required documents, focusing on Device Master File and Plant Master File.
Apply for Test License (MD13): Submit your test license application through the CDSCO MD Online Portal.
Plan Audit: Schedule audits with notified bodies early to fit within your timeline.
Submit Manufacturing License Application (MD3): Once testing and documentation are ready, file your MD5 license application.
Stay Responsive: Assign a regulatory coordinator to promptly handle any queries from CDSCO or auditors.
By following these actionable steps, you position your urethral catheter product for timely approval and successful market launch in India.
For detailed assistance tailored to your specific needs, connect with our expert regulatory consultants to streamline your CDSCO licensing journey.
