CDSCO License for Intermittent urethral drainage catheter, antimicrobial

Comprehensive Guide to CDSCO Licensing for Intermittent Urethral Drainage Catheter, Antimicrobial (Class B)

As experienced regulatory consultants with over 25 years of expertise and having successfully assisted 500+ companies in navigating the CDSCO licensing landscape, we understand the nuances and critical steps involved in bringing a Class B medical device like the antimicrobial intermittent urethral drainage catheter to the Indian market. This device, a sterile, flexible or rigid catheter designed for episodic urine drainage via self-application, falls under the urology category with Notification File No. 29/Misc./03/2020-DC (145) dated 23.08.2021. Due to its moderate risk classification, the regulatory journey requires meticulous preparation and compliance.

CDSCO Regulatory Framework for Intermittent Urethral Drainage Catheters

The Central Drugs Standard Control Organization (CDSCO) administers medical device licensing in India under the Medical Device Rules, 2017. The antimicrobial intermittent urethral drainage catheter is classified as a Class B device. This classification dictates that manufacturers must obtain an MD5 manufacturing license issued by the State Licensing Authority, while importers require an MD15 import license granted by the Central Licensing Authority.

Risk Classification and License Requirements

• Device Risk Class: B (Low to Moderate Risk)
• Manufacturing License: MD5 License (Application Form MD3) via State Authority
• Import License: MD15 License (Application Form MD14) via Central Authority

Class B devices like this catheter are subject to rigorous quality, safety, and efficacy standards but benefit from a relatively streamlined approval process compared to higher-risk classes.

Manufacturing License Process (MD5)

The MD5 license process generally spans 3 to 4 months and involves several key phases:

1. Test License Application (Form MD13): The first step is securing a test license, valid for 6 months, to allow product testing and validation. This typically takes 1.5 to 2 months to obtain.

2. Product Testing: Samples must be tested at CDSCO-approved laboratories to verify compliance with Indian standards. You can consult the list of approved testing laboratories to select an authorized facility.

3. Document Preparation: Compile comprehensive technical documentation, including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, and Risk Management File.

4. License Application Submission: Submit the manufacturing license application on Form MD3 through the CDSCO MD Online Portal.

5. Audit by Notified Body: A third-party notified body will conduct a factory audit to verify compliance with Good Manufacturing Practices (GMP). Refer to the Notified Bodies List to choose an appropriate auditor.

6. Query Resolution: Address any observations or queries raised by the licensing authority or auditor promptly to avoid delays.

7. Grant of License: Upon satisfactory completion, the MD5 license is issued (Form MD5).

Manufacturing License Documents Required

For your antimicrobial intermittent urethral drainage catheter, prepare the following documents meticulously:

• Company Constitution (e.g., Incorporation Certificate, Partnership Deed)
• Proof of ownership or valid lease agreement of manufacturing premises
• Details and qualifications of technical staff
• Fire and Pollution NOCs
• Device Master File (DMF): Detailed device specifications, drawings, manufacturing processes, and quality controls (See our Device Master File guide)
• Plant Master File (PMF): Description of manufacturing facility, quality management systems, and infrastructure (Learn more from our Plant Master File guide)
• Essential Principles Checklist demonstrating compliance with safety and performance requirements
• Risk Management File detailing hazard analysis and mitigation strategies (Refer to our Risk Management resource)
• Test Reports from CDSCO-approved laboratories
• Labels and Instructions for Use (IFU) compliant with CDSCO labeling guidelines
• Quality Management System (QMS) documents, preferably ISO 13485:2016 certification

Import License Process (MD15)

For importers, the MD15 license issued by the Central Licensing Authority is mandatory. The process takes approximately 5 to 6 months and includes:

• Document Preparation: Assemble relevant documentation, including the 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.

• Application Submission: Apply using Form MD14 through the CDSCO MD Online Portal.

• Review and Query Resolution: Respond promptly to departmental queries.

• License Grant: Once all criteria are met, the MD15 license is issued.

Notably, test licenses are not required for import applications, but comprehensive product documentation and quality certifications are critical.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License or equivalent distribution license in India
• Company Constitution documents

Timeline and Processing Duration

Government Fees and Costs

• MD5 Manufacturing License:

  • Application Fee: ₹5,000
  • Per Product Fee: ₹500

• MD15 Import License:

  • Class B Devices: ₹2,000 per site
  • Per Product Fee: ₹1,000

Additional costs include fees for product testing at government-approved laboratories, auditor fees for factory inspections, and potential consultancy fees for documentation assistance.

Common Challenges and Solutions

Challenge: Delays in obtaining test licenses and audit scheduling.

Solution: Initiate test license application early and coordinate with notified bodies well in advance. Keep all documents ready to avoid back-and-forth.

Challenge: Incomplete or inconsistent documentation leading to queries.

Solution: Use standardized templates for DMF and PMF, and conduct internal audits before submission. Our guides on DMF and PMF offer detailed assistance.

Challenge: Navigating the complex CDSCO portal and tracking application status.

Solution: Familiarize yourself with the CDSCO MD Online Portal and maintain regular communication with licensing authorities.

Expert Consultation and Support

With our 25+ years of experience and a track record of over 500 successful CDSCO license acquisitions, we offer end-to-end support—from initial classification advice, documentation preparation, audit readiness, to application submission and post-license compliance. Our practical insights help you avoid common pitfalls and accelerate market entry.

Getting Started with Your CDSCO License Application

1. Classify Your Device Accurately: Confirm your catheter’s Class B status using the Medical Device Classification tool.

2. Prepare Test License Application: Begin by filing Form MD13 for the test license via the CDSCO MD Online Portal. This is essential before manufacturing license submission.

3. Select Testing Laboratory: Choose a CDSCO-approved lab from the Testing Laboratories list for product validation.

4. Compile Documentation: Develop your Device Master File, Plant Master File, Risk Management File, and other required documents meticulously.

5. Engage a Notified Body: Identify and coordinate with a notified body for your manufacturing site audit. Refer to the Notified Bodies List for options.

6. Submit Application & Track Progress: Upload your application through the online portal and maintain proactive communication with CDSCO to address queries promptly.

By following this structured approach, manufacturers and importers of antimicrobial intermittent urethral drainage catheters can confidently navigate the Indian regulatory landscape and achieve timely licensing compliance.

For personalized assistance and detailed consultation tailored to your product, contact our expert regulatory team today.