CDSCO License for Closed-ended wearable urine collection bag, non- sterile

Comprehensive Guide for CDSCO License of Closed-ended Wearable Urine Collection Bag (Class A Medical Device)

As a trusted regulatory consultancy with over 25 years of experience and having supported 500+ manufacturers and importers, we understand the nuanced requirements for obtaining a CDSCO license for Class A medical devices like the closed-ended wearable urine collection bag. This device, classified under urology, is a non-sterile flexible plastic pouch designed to connect to urinary catheters, enabling discreet urine collection without drainage openings. Ensuring compliance with CDSCO regulations is critical for legal marketing and patient safety in India.

CDSCO Regulatory Framework for Closed-ended Wearable Urine Collection Bags

The Central Drugs Standard Control Organization (CDSCO) governs the import and manufacture of medical devices in India. Following the Medical Device Rules (MDR) 2017, devices are categorized by risk class, which determines the licensing and regulatory controls. Our device falls under Class A (low risk), regulated primarily by State Licensing Authorities through the MD5 manufacturing license.

Risk Classification and License Requirements for Class A Devices

Closed-ended wearable urine collection bags are classified as Class A devices owing to their low-risk profile. Class A devices require:

• Manufacturing License: MD5 (Application Form MD3)
• Test License: MD13 (for initial product testing)

The process involves a test license, product testing at government-approved labs, audit by a notified body, and final license grant.

Manufacturing License Process (MD5) for Class A Devices

The MD5 license is granted by the State Licensing Authority and typically takes 3 to 4 months from start to finish, dependent on timely submissions and audit scheduling. The detailed steps include:

1. Apply for Test License (Form MD13): This allows initial product testing and takes approximately 1.5 to 2 months.
2. Product Testing: Conduct testing at CDSCO-approved laboratories to verify compliance with Indian standards. Use the list of testing laboratories for authorized centers.
3. Documentation Preparation: Compile complete technical and quality files including Device Master File and Plant Master File.
4. Submit Application for MD5 License (Form MD3): Apply via the CDSCO MD Online Portal with all supporting documents.
5. Audit by Notified Body: A notified body conducts an onsite audit; consult the Notified Bodies List to select your auditor.
6. Resolve Queries: Address any clarifications raised by the licensing authority or auditor promptly.
7. Grant of MD5 License: Upon successful review, the license is granted.

Manufacturing License Documents Required

For the closed-ended wearable urine collection bag, prepare the following documents:

• Company Constitution and Incorporation Certificate
• Proof of Ownership/Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design, materials, and specifications (see our Device Master File guide)
• Plant Master File (PMF) describing manufacturing setup (Plant Master File guide)
• Essential Principles Checklist confirming compliance with safety standards
• Risk Management File documenting hazard analysis (Risk Management guide)
• Test Reports from government-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485 certification preferred)

Import License Process (MD15) for Class A Devices

If you intend to import this device, the MD15 import license is issued by the Central Licensing Authority and typically takes 5 to 6 months. However, for Class A devices, importers generally focus on obtaining the MD15 license with the following steps:

1. Prepare documentation including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016, CE certification if applicable, and Device/Plant Master Files.
2. Submit application on the CDSCO MD Online Portal.
3. Respond to queries from CDSCO promptly.
4. Receive MD15 license upon approval.

Import License Documents Required

• Valid Manufacturing License from exporting country
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution

Timeline and Processing Duration

Timely submission of complete documentation and proactive communication with licensing authorities can help avoid delays.

Government Fees and Costs

For Class A device manufacturing license (MD5):

• Application Fee: Rs 5,000 per application
• Per Product Fee: Rs 500

For import license (MD15):

• Site Fee: Approx. $1,000 per site
• Per Product Fee: $50

Additional costs include product testing fees at approved labs and notified body audit charges, which vary based on the service provider.

Common Challenges and Solutions

• Incomplete Documentation: Ensure all files like Device Master File, Risk Management File, and test reports are accurate and up-to-date.
• Delays in Product Testing: Schedule lab testing early using government-approved labs to avoid bottlenecks.
• Audit Non-compliance: Prepare for audits by thoroughly implementing ISO 13485 QMS and maintaining plant records.
• Query Resolution Delays: Assign dedicated regulatory personnel to respond promptly to CDSCO queries.

Expert Consultation and Support

Navigating the CDSCO licensing process can be complex. Our expert team has assisted over 500 companies in successfully obtaining MD5 and MD15 licenses. We offer end-to-end support including:

• Gap analysis of existing documentation
• Preparation of Device and Plant Master Files
• Coordination with notified bodies and testing labs
• Audit readiness and QMS consulting
• Application submission and follow-ups

Getting Started with Your CDSCO License Application

1. Evaluate your Device Classification: Confirm Class A status using the Medical Device Classification guide.
2. Engage a Notified Body: Select an appropriate notified body for audit from the Notified Bodies List.
3. Apply for Test License (MD13): Submit your test license application on the CDSCO MD Online Portal.
4. Initiate Product Testing: Send your samples to approved labs listed here.
5. Prepare Documentation: Develop a comprehensive Device Master File and Plant Master File.
6. Submit MD5 License Application: After successful testing and audit readiness, apply for the MD5 license.

Taking these proactive steps ensures a smoother licensing journey, allowing you to bring your closed-ended wearable urine collection bags to the Indian market compliantly and efficiently.

For personalized assistance with your CDSCO license, reach out to our consultancy team with 25+ years of expertise to guide you every step of the way.