CDSCO License for Continous Irrigation Catheter

Comprehensive Guide to CDSCO Licensing for Continuous Irrigation Catheters (Class B Medical Device)

As a trusted regulatory consultancy with over 25 years of experience and having supported 500+ companies in securing CDSCO licenses, we understand the nuances of medical device approvals in India. Today, we focus on the Continuous Irrigation Catheter, a Class B medical device under the catheter category, notified under 29/Misc/3/2017-DC (292) dated 06.06.2018. This device is intended to introduce fluids into body cavities other than blood vessels, drain fluids, or evaluate physiological conditions—critical applications that demand strict regulatory compliance.

CDSCO Regulatory Framework for Continuous Irrigation Catheters

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules (MDR) 2017, which classifies devices based on risk. Continuous Irrigation Catheters fall under Class B (low to moderate risk). This classification impacts the licensing pathway, inspection requirements, and timelines.

Risk Classification and License Requirements

Continuous Irrigation Catheters are Class B devices. For Class A and B devices, manufacturers must obtain an MD5 license issued by the State Licensing Authority. This involves a multi-step process including a test license, product testing, documentation, and audit by a notified body.

To verify device classification and regulatory requirements, manufacturers can refer to the Medical Device Classification guide.

Manufacturing License Process (MD5) for Continuous Irrigation Catheters

The MD5 license process for Class B devices typically spans 3 to 4 months and involves the following steps:

1. Test License (Form MD13): Apply for a test license to legally manufacture the device for testing purposes. This usually takes 1.5 to 2 months to be granted.

2. Product Testing: Once the test license is obtained, submit your Continuous Irrigation Catheter samples to government-approved labs for testing. Refer to the list of CDSCO-approved testing laboratories to select the appropriate facility.

3. Documentation Preparation: Compile all required documents, including Device Master File (DMF), Plant Master File (PMF), risk management files, and quality management system (QMS) documentation.

4. MD5 License Application (Form MD3): Submit your application through the CDSCO MD Online Portal, including all documentation and test reports.

5. Audit by Notified Body: An audit will be conducted by a notified body listed on the Notified Bodies List to verify compliance with MDR requirements.

6. Queries Resolution: Address any queries raised by the state licensing authority or notified body promptly to avoid delays.

7. Grant of License: Upon satisfactory audit and query resolution, the MD5 license will be issued on Form MD5.

For a detailed walkthrough, our MD5 License Guide offers valuable insights.

Manufacturing License Documents Required for Continuous Irrigation Catheters

The following documents are essential for the MD5 application:

• Company Constitution (e.g., Memorandum & Articles of Association)
• Proof of ownership or lease agreement of manufacturing premises
• Qualification and experience certificates of technical staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) detailing product specifications and design (see our DMF guide)
• Plant Master File (PMF) describing manufacturing facilities and processes (PMF guide here)
• Essential Principles Checklist confirming compliance with safety and performance requirements
• Risk Management File demonstrating hazard identification and mitigation (Risk Management insights)
• Product Test Reports from CDSCO-approved labs
• Product labels and packaging details
• Instructions for Use (IFU)
• Quality Management System (QMS) certificates (preferably ISO 13485:2016)

Import License Process (MD15) for Continuous Irrigation Catheters

If you are an importer instead of a manufacturer, the import license (MD15) is issued by the Central Licensing Authority and takes approximately 5 to 6 months. The process does not require a test license but involves detailed documentation and regulatory compliance checks.

The MD15 application requires submitting Form MD14 through the CDSCO MD Online Portal, followed by query resolution and license grant. Refer to our Import License Guide for comprehensive assistance.

Import License Documents Required

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

Timeline and Processing Duration

For imports (MD15 license), expect approximately 5 to 6 months from application to license grant.

Government Fees and Costs

For a Continuous Irrigation Catheter (Class B device), the fee structure is as follows:

• Test License (MD13): Rs. 5,000 per application
• MD5 Manufacturing License: Rs. 5,000 per application + Rs. 500 per product

These fees are payable through the CDSCO portal during application submission.

Common Challenges and Solutions

1. Delays in Test License Approval:

• Tip: Ensure all test license application documents are complete and accurate. Early engagement with CDSCO officials can expedite processing.

2. Product Testing Failures:

• Tip: Conduct pre-testing in accredited private labs before submitting samples to CDSCO-approved labs to identify and mitigate issues early.

3. Incomplete Documentation:

• Tip: Use checklists aligned with CDSCO requirements. Our Device Master File guide can help you prepare comprehensive documentation.

4. Audit Non-Compliance:

• Tip: Familiarize your team with MDR and audit expectations. Engage with notified bodies early to understand audit scope.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for Class B devices like the Continuous Irrigation Catheter. Our consultancy offers:

• End-to-end license application management
• Documentation preparation and review
• Pre-audit readiness assessments
• Training for your technical and regulatory teams

Our proven track record with over 500 successful licenses ensures your application is in safe hands.

Getting Started with Your CDSCO License Application

Practical Next Steps:

1. Confirm Device Classification: Verify your Continuous Irrigation Catheter is Class B per CDSCO rules.

2. Register on CDSCO MD Online Portal: Create your company profile at the CDSCO MD Online Portal.

3. Prepare Test License Application: Gather all required documents for Form MD13 and submit.

4. Identify Testing Laboratory: Choose a CDSCO-approved lab from the Testing Laboratories list.

5. Develop Comprehensive Documentation: Assemble your Device Master File, Plant Master File, Risk Management File, and QMS documents.

6. Engage a Notified Body: Schedule your audit with a notified body from the official Notified Bodies List.

7. Submit MD5 License Application: Once testing and documentation are ready, submit Form MD3 through the CDSCO portal.

8. Address Queries Promptly: Maintain close communication with CDSCO and the notified body to resolve queries swiftly.

By following these precise steps and leveraging expert support, manufacturers of Continuous Irrigation Catheters can confidently navigate the CDSCO licensing process and successfully enter the Indian market.

For personalized assistance and detailed guidance tailored to your product, contact our regulatory experts today.