CDSCO License for Coude Catheters

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

Coude catheters are specialized urinary catheters designed for the treatment and diagnosis of bladder conditions by facilitating the injection of therapeutic or diagnostic liquids. Classified as Class B medical devices under India's regulatory framework, these catheters require meticulous adherence to the Central Drugs Standard Control Organization (CDSCO) licensing process to ensure market authorization. With over 25 years of experience and having assisted more than 500 companies, we provide you with a detailed, practical roadmap for obtaining your CDSCO manufacturing or import license for Coude catheters.

CDSCO Regulatory Framework for Coude Catheters

Coude catheters fall under the medical device category "Catheters" and are notified under the CDSCO notification 29/Misc/3/2017-DC (292) dated 06.06.2018. As a Class B device, they are considered low moderate risk, and their regulatory oversight primarily involves the State Licensing Authority for manufacturing and the Central Licensing Authority for import. Compliance with the Medical Device Rules, 2017 (amended) is mandatory.

Risk Classification and License Requirements

India follows a four-tier risk classification system: Class A (low risk), B (low moderate risk), C (moderate high risk), and D (high risk). Coude catheters are Class B devices, which means:

• Manufacturing License: Must obtain an MD5 license from the State Licensing Authority.
• Import License: Requires an MD15 license from the Central Licensing Authority.

This classification dictates the application process, documentation, fees, and timelines.

Manufacturing License Process (MD5 for Class B Devices)

The manufacturing license process for Coude catheters involves several sequential steps:

1. Test License (Form MD13): Before applying for the MD5 license, manufacturers must secure a test license, valid for 6 months, allowing limited manufacturing to conduct product testing.
2. Product Testing: Conduct product testing at CDSCO-approved government labs. Informed selection of testing laboratories is critical; you can review the list of CDSCO-approved testing labs here.
3. Document Preparation: Prepare a comprehensive dossier, including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, and Risk Management File.
4. Application Submission: Submit the MD5 application (Form MD3) via the CDSCO MD Online Portal.
5. Audit by Notified Body: Arrange for an audit by a notified body approved by CDSCO. You can check the notified bodies list here.
6. Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
7. Grant of License: Upon satisfactory review and audit, the MD5 license is granted, permitting commercial manufacturing.

Manufacturing License Documents Required

To ensure a smooth application experience, prepare the following documents tailored for Coude catheters:

• Company Constitution and Incorporation Documents
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Technical Staff Qualification and Experience Records
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF): Detailed design, specifications, manufacturing process, and validation data. Our expert Device Master File guide can assist you in this preparation.
• Plant Master File (PMF): Infrastructure, equipment, utilities, and quality assurance systems. Check our Plant Master File guide for detailed insights.
• Essential Principles Checklist: Compliance with Indian Medical Device Rules and relevant standards.
• Risk Management File: Hazard analysis and mitigation strategies aligned with ISO 14971 principles. Learn more about medical device risk management.
• Test Reports from Approved Labs
• Labels and Instructions for Use (IFU)
• Quality Management System Documents (QMS), preferably ISO 13485:2016 certified.

Import License Process (MD15 for Class B Devices)

For importers of Coude catheters, the MD15 license is mandatory and involves:

1. Document Compilation: Prepare documents 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.
2. Application Submission: Apply using Form MD14 via the CDSCO MD Online Portal.
3. Query Handling: Respond to departmental queries swiftly.
4. License Issuance: The Central Licensing Authority grants the MD15 import license.

Import License Documents Required

• Manufacturing License of the Device Issued by the Country of Origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution Documents

Timeline and Processing Duration

For Coude catheters, the entire manufacturing license process typically spans 3 to 4 months, factoring in audit and testing. Import licenses take slightly longer due to central authority review.

Government Fees and Costs

• MD5 Manufacturing License Fees: Rs. 5,000 per application plus Rs. 500 per product (Coude catheters count as one product category).
• Test License Fee (MD13): Included in the manufacturing license process.
• MD15 Import License Fees: For Class B devices, approximately $2,000 per site and$1,000 per product.

Budget for additional costs such as notified body audit fees, testing charges at government-approved laboratories, and consultancy fees as applicable.

Common Challenges and Solutions

Challenge: Delays in product testing due to limited slots at government-approved labs.

Solution: Early booking of testing slots and considering multiple approved labs as per CDSCO’s testing laboratory list can mitigate this risk.

Challenge: Incomplete or inconsistent documentation leading to queries or rejection.

Solution: Engage with regulatory experts to ensure your Device and Plant Master Files, Risk Management, and QMS documents are robust and audit-ready.

Challenge: Audit non-conformities during notified body inspection.

Solution: Conduct internal mock audits ahead of notified body inspections to identify and rectify gaps.

Expert Consultation and Support

With over 25 years of experience in CDSCO licensing and regulatory compliance, we have successfully guided 500+ companies through the complexities of medical device approvals in India. Our end-to-end support includes:

• Detailed gap analysis and documentation support
• Liaison with notified bodies and CDSCO authorities
• Audit preparation and QMS implementation
• Training for regulatory and technical teams

Getting Started with Your CDSCO License Application for Coude Catheters

1. Assess Your Device Classification: Confirm Coude catheters as Class B under current CDSCO rules using resources like the Medical Device Classification Guide.
2. Initiate Test License Application: Apply for the test license (Form MD13) on the CDSCO MD Online Portal to start limited manufacturing and testing.
3. Plan Product Testing: Coordinate with CDSCO-approved laboratories early to schedule testing.
4. Prepare Documentation: Compile your Device Master File, Plant Master File, Risk Management File, and QMS documents with expert assistance.
5. Schedule Notified Body Audit: Identify and engage a notified body from the authorized list to conduct your mandatory audit.
6. Submit MD5 Application: Once testing and audit are complete, file your MD5 manufacturing license application (Form MD3) online.
7. Respond to Queries Promptly: Maintain open communication with CDSCO and notified bodies to resolve any queries efficiently.

Taking these actionable steps will streamline your regulatory journey, enabling timely market access for your Coude catheters in India. For personalized support, reach out to our regulatory consultancy to leverage our expertise and accelerate your CDSCO approval process.