CDSCO License for Upper Urinary  Tract Catheter

Comprehensive Guide to CDSCO Licensing for Upper Urinary Tract Catheters (Class B)

Upper Urinary Tract Catheters are critical medical devices designed to facilitate drainage from the bladder up to the upper urinary tract. Given their invasive nature and clinical significance, regulatory compliance with CDSCO (Central Drugs Standard Control Organization) is mandatory for manufacturers and importers aiming to market these devices in India. With over 25 years of expertise and having assisted 500+ companies, we provide an in-depth walkthrough of the licensing process specifically tailored for Class B devices like Upper Urinary Tract Catheters.

CDSCO Regulatory Framework for Upper Urinary Tract Catheters

The CDSCO regulates medical devices under the Medical Device Rules, 2017, ensuring safety, quality, and performance standards. Upper Urinary Tract Catheters fall under the category of Catheters and are notified as per Notification No. 29/Misc/3/2017-DC (292) dated 06.06.2018. This notification mandates compliance with specific regulatory pathways, including obtaining a manufacturing license (MD5) for Class B devices.

Risk Classification and License Requirements for Class B Devices

According to CDSCO's classification, Class B devices present a low to moderate risk. Upper Urinary Tract Catheters are designated Class B, which requires manufacturers to obtain an MD5 license. This license is issued by the State Licensing Authority and involves a detailed process including testing, documentation, and audit by a notified body.

For an overview of device classifications, manufacturers can refer to the Medical Device Classification guide.

Manufacturing License Process (MD5) for Upper Urinary Tract Catheters

The pathway to an MD5 license involves several critical steps:

1. Test License Application (Form MD13): Before manufacturing license application, a test license must be secured. This allows limited production for testing purposes and typically takes 1.5 to 2 months for approval.

2. Product Testing: The catheter must undergo testing at CDSCO-recognized laboratories. Testing covers biocompatibility, sterility, mechanical properties, and other relevant parameters. Refer to the List of Testing Laboratories for approved labs.

3. Document Preparation: Compile comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, test reports, labeling, and Instructions for Use (IFU). Our detailed Device Master File guide and Plant Master File guide can assist in preparation.

4. Application Submission (Form MD3): Apply for the manufacturing license via the CDSCO MD Online Portal.

5. Audit by Notified Body: A notified body conducts a thorough audit of the manufacturing facility and quality management systems. Find the list of notified bodies here.

6. Resolution of Queries: Address any observations or queries raised by CDSCO or the notified body promptly.

7. License Grant (Form MD5): Upon successful audit and document compliance, the State Licensing Authority issues the manufacturing license.

Manufacturing License Documents Required for Upper Urinary Tract Catheters

To ensure a smooth licensing process, the following documents must be meticulously prepared:

• Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of ownership or lease agreement of manufacturing premises
• Details and qualifications of technical staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (including design, specifications, manufacturing process)
• Plant Master File (facility layout, equipment details, utilities)
• Essential Principles Checklist demonstrating compliance with Indian medical device standards
• Risk Management File aligned with ISO 14971 principles; practical implementation tips available in our Risk Management guide
• Test Reports from CDSCO-approved laboratories
• Labels and Instructions for Use (IFU) compliant with regulatory guidelines
• Quality Management System (QMS) documents, preferably ISO 13485 certified

Import License Process (MD15) for Upper Urinary Tract Catheters

If you are an importer, obtaining an MD15 import license from the Central Licensing Authority is mandatory. The process is as follows:

• Prepare required documentation including manufacturing license of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device Master File, Plant Master File, Wholesale license, and company constitution.
• Submit application on the CDSCO MD Online Portal.
• Respond to any departmental queries.
• License grant typically occurs within 5-6 months.

For detailed guidance, review our Import License guide.

Timeline and Processing Duration

This timeline assumes prompt responses and complete documentation. Delays often arise due to incomplete submissions or audit non-compliance.

Government Fees and Costs

For Class B devices such as Upper Urinary Tract Catheters, the fee structure is as follows:

• Application Fee: Rs. 5000 per application
• Product Fee: Rs. 500 per product

Additional costs may include notified body audit fees, product testing charges, and consultancy fees if applicable.

Common Challenges and Solutions

Challenge 1: Incomplete Documentation Many applicants underestimate the depth of documentation required. We recommend starting documentation early and using checklists to ensure completeness.

Challenge 2: Delays in Product Testing Testing capacity at government-approved labs can be limited. Pre-book your slots and prepare samples meticulously to avoid repeated tests.

Challenge 3: Audit Non-Compliance Audit failures often relate to QMS deviations or facility inadequacies. Conduct pre-audit internal reviews and training.

Challenge 4: Query Resolution Delays Timely and clear responses to CDSCO queries are critical. Assign dedicated personnel for communication.

Expert Consultation and Support

Navigating CDSCO licensing for Upper Urinary Tract Catheters can be complex. Our seasoned regulatory team has a proven track record of guiding manufacturers through every step — from test license applications to audit readiness and final license grant. We provide tailored solutions to expedite approvals while ensuring regulatory compliance.

Getting Started with Your CDSCO License Application

1. Assess Your Classification: Confirm your device is Class B and understand the MD5 license requirements.
2. Initiate Test License Application: Apply for Form MD13 early on the CDSCO MD Online Portal.
3. Engage a Notified Body: Select and coordinate with an accredited notified body for the audit. Refer to the notified bodies list.
4. Plan Product Testing: Schedule product testing at an approved laboratory.
5. Prepare Documentation: Utilize our Device Master File and Plant Master File guides.
6. Submit Application: Upload all documentation and apply for the manufacturing license (Form MD3) via the CDSCO portal.
7. Coordinate Audit and Follow-up: Prepare for audit, promptly address queries, and track application status.

By adhering to these steps and leveraging expert support, you can significantly enhance your chances of securing the MD5 manufacturing license for your Upper Urinary Tract Catheter efficiently and compliantly.

For personalized assistance and to initiate your CDSCO licensing journey, contact our regulatory consultancy team today.